Immunohistological analysis of the duodenal bulb: a new method for celiac disease diagnosis in children Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-05-26 Luigina De Leo, Vincenzo Villanacci, Fabiana Ziberna, Serena Vatta, Stefano Martelossi, Grazia Di Leo, Chiara Zanchi, Matteo Bramuzzo, Fabiola Giudici, Alessandro Ventura, Tarcisio Not
Background and Aims Anti-tissue transglutaminase antibodies (anti-tTG) have simplified celiac disease (CD) diagnosis. However, in atypical forms of CD, intestinal biopsy is still required. This prospective study investigates whether histological analysis of the duodenal bulb combined with intestinal IgA anti-tTG deposit immunoassay makes CD diagnosis possible in at-risk children with low concentrations of serum anti-tTG. Methods Histological and intestinal IgA anti-tTG deposit immunoassays were used. Results Two hundred forth-five symptomatic children positive for serum anti-tTG (>7 U/mL) were enrolled and divided into 3 groups: extensive duodenal atrophy – 209/245, with IgA anti-tTG deposits throughout the duodenum and high serum anti-tTG concentrations (157±178 U/mL); bulb duodenal atrophy – 22/245, with widespread IgA anti-tTG deposits in 9 and in the bulb alone in 13, and low serum anti-tTG concentrations (13.9±8.7 U/mL); normal duodenum – 14/245, with widespread IgA anti-tTG deposits in 8 and in the bulb alone in 6, and low serum anti-tTG concentrations (10.6±6.2 U/mL). All of the patients in the first 2 groups were diagnosed with CD, and 8 from the third group. All improved after one year of gluten-free diet. Bulb duodenal analysis led to a 12% (30/245) increase in CD diagnosis. No CD-related lesions were observed in the 30 controls. Conclusions In children at risk for CD, bulb duodenum biopsy is essential to identify villous atrophy and detect IgA anti-tTG deposits even in absence of intestinal lesions. These mucosal autoantibodies could well represent a new standard for diagnosing CD.
Incidence of Interval Colorectal Cancer Attributable to an Endoscopist in Clinical Practice Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-05-24 Furkan U. Ertem, Uri Ladabaum, Ateev Mehrotra, Shahrzad Tehranian, Zhuo Shi, Melissa Saul, Michele Morris, Seth D. Crockett, Robert E. Schoen
Background and Aims Endoscopists who encounter an interval colorectal cancer (I-CRC) may be concerned about the implications because I-CRCs may represent a lapse in colonoscopy quality and a missed opportunity for prevention. To determine the I-CRC rate per colonoscopy examination and to examine the effect of colonoscopy volume and adenoma detection rate (ADR) on the number of I-CRCs attributable to an endoscopist. Methods We determined the rate of I-CRC diagnosis per outpatient colonoscopy examination by measuring the incidence of CRC diagnosis in practice and by assessing, via literature review, the percentage of cancers that are interval. We also estimated the number of attributable I-CRCs as a function of ADR and colonoscopy volume. Results Among 93,562 colonoscopies performed in 2013 to 2015 by 120 physicians in 4 diverse U.S. medical centers, 526 CRCs were diagnosed (0.6%). Of 149,556 CRCs in the published literature, 7,958 were I-CRCs (5.25% ± 0.94). With rates of 0.6% (CRC per colonoscopy) and 5.25% (I-CRC per CRC) the rate of I-CRC is 1 per 3,174 colonoscopies (95% CI, 1 per 2,710-1 per 3,875). An endoscopist at the median of colonoscopy volume (316/year), in the lowest ADR quintile of detection (7%-19%) would have an I-CRC attributed every 8.2 years, or 4.2 I-CRCs in a 35-year career, versus every 16.7 years, or 2.0 I-CRCs in a 35-year career, for an endoscopist in the highest ADR quintile (33%-52%). Conclusions An average-volume endoscopist will have 2 to 4 attributable I-CRCs in a 35-year career, but the frequency will vary depending on colonoscopy volume and ADR.
Effects of Helicobacter pylori eradication for metachronous gastric cancer prevention: a randomized controlled trial Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-05-22 Ji Min Choi, Sang Gyun Kim, Jeongmin Choi, Jae Yong Park, Sooyeon Oh, Hyo-Joon Yang, Joo Hyun Lim, Jong Pil Im, Joo Sung Kim, Hyun Chae Jung
Background and AimsWhether eradication of Helicobacter pylori (H pylori) reduces incidence of metachronous gastric cancer (MGC) is still debatable. We aimed to evaluate the long-term effect of H pylori eradication on the development of MGC after endoscopic gastric tumor resection.MethodsWe undertook an open-label, prospective, randomized controlled trial at a tertiary hospital in Seoul, Korea. Participants were recruited during April 2005 to February 2011 and followed until December 2016. We assigned 898 patients with H pylori infection treated with endoscopic resection for gastric dysplasia or early gastric cancer to receive (n =442) or not receive (n =456) eradication therapy using a random-number chart. Eradication group patients received oral omeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily for a week; control group patients received no H pylori treatment. The primary outcome was the incidence of MGC (intention-to-treat analysis).ResultsThe 877 patients who attended ≥1 follow-up examination (eradication group, 437; control group, 440) were analyzed. Median follow-up was 71.6 months (IQR, 42.1–90.0 months). MGC developed in 18 (4.1%) eradication and 36 (8.2%) control group patients (log-rank test, P=0.01). In our yearly analysis, the effect of eradication showed a significant difference in 5 years after allocation (log-rank test, P=0.02). The adjusted HR for control group was 2.02 (95% CI, 1.14–3.56; P=0.02), compared with the eradication group.ConclusionsH pylori eradication significantly reduces the incidence of MGC after ER of gastric tumors and should be considered for H pylori-positive gastric tumor patients treated with ER. (ClinicalTrials.gov, number NCT01510730)
Outcomes of endoscopic resection for superficial duodenal epithelial neoplasia Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-05-09 Naohisa Yahagi, Motohiko Kato, Yasutoshi Ocihai, Tadateru Maehata, Motoki Sasaki, Yoshiyuki Kiguchi, Teppei Akimoto, Atsushi Nakayama, Ai Fujimoto, Osamu Goto, Toshio Uraoka
Background and AimPancreaticoduodenectomy is an invasive procedure, and endoscopic resection (ER) is an alternative therapy. However, details regarding the outcomes of ER are unknown, especially for superficial duodenal epithelial neoplasia (SDET). The aim of this study was to elucidate the outcomes of ER for SDET and to compare endoscopic mucosal resection (EMR) with endoscopic submucosal dissection (ESD).MethodsThis was a retrospective observational study. From June 2010 to June 2017, 320 cases of endoscopically resected SDET (146 EMR-treated cases and 174 ESD-treated cases) were included in this study. We analyzed the proportions of en bloc resection, R0 resection, perforation and bleeding as outcomes of ER and compared outcomes between the EMR and ESD groups. Next, we collected data on the features and clinical course of cases with adverse events.ResultsThe proportions of en bloc resection and R0 resection among all cases were 96.6% and 83.4%, respectively. In over 95% of cases, ESD achieved en bloc resection, regardless of lesion size. The incidences of perforation and bleeding were 8.8% and 3.4%, respectively, and the former was largely successfully managed by conservative treatment. The mortality rate was 0%, and all patients were discharged, with a median hospital stay of 8.5 days (range 4–52 days). Evaluation of the hospital stay duration according to lesion circumference revealed a significantly longer duration for lesions present on the medial wall than for other lesions (median 41 vs 7 days, p=0.0331).ConclusionThe present study revealed that ER achieved secure en bloc resection, with the treatment type (ESD or EMR) selected according to the lesion size. A lesion located on the medial wall was associated with worse outcomes, such asprolonged hospital stay after perforation.
Screening for gastric cancer with magnetically controlled capsule gastroscopy in asymptomatic individuals Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-05-09 An-Jing Zhao, Yang-Yang Qian, Hui Sun, Xi Hou, Jun Pan, Xiao Liu, Wei Zhou, Yi-Zhi Chen, Xi Jiang, Zhao-Shen Li, Zhuan Liao
Background and AimsGastric cancer (GC) is the fourth most common cancer and the fourth leading cause of cancer death worldwide. In some Asian countries, screening esophagogastroduodenoscopy (EGD) has greatly improved the survival rate. However, patients’ discomfort and the need for sedation may limit adherence to screening programs. Prior studies have shown good tolerance and good agreement of magnetically controlled capsule gastroscopy (MCCG) with EGD. This study was designed to assess the application of MCCG in GC detection in an asymptomatic population.MethodsIn this observational cohort study, 3182 asymptomatic individuals undergoing MCCG in 99 participating medical examination centers from April to December 2016 were enrolled. Patients with ulcers and suspected malignancies were referred for gastroscopy and biopsy. The detection rate of GC and focal lesions were used to explore the application of MCCG in asymptomatic individuals.ResultsSeven patients (0.22%) were diagnosed with GC in the enrolled 3182 individuals, accounting for 0.74% (7/948) in patients over 50. No gender disparity was observed and all were aged over 50 years. EGD and biopsy confirmed adenocarcinoma in all cases of suspected malignancy. Meanwhile, benign polyps, gastric ulcers, and submucosal tumors were found in 10.4%, 4.9%, and 3.6% of patients, respectively. There was a trend for prevalence of focal lesions to increase with age. MCCG examination proved to be safe.ConclusionsMCCG can detect cancer and benign lesions and is safe and clinically feasible in a large population. Studies of its role in a screening program should be considered.
Inspection of endoscope instrument channels after reprocessing using a prototype borescope Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-05-09 Adarsh M. Thaker, Stephen Kim, Alireza Sedarat, Rabindra R. Watson, V. Raman Muthusamy
Background and AimsVisual inspection of the instrument channel has been proposed as a quality assurance step during endoscope reprocessing. However, the nature and severity of findings in a broad array of endoscopes (gastroscopes, colonoscopes, duodenoscopes, and echoendoscopes) after systemic implementation of an inspection protocol remain unknown. In addition, a study using borescope inspection in upper endoscopes and colonoscopes raised concerns about persistent simethicone residue despite full reprocessing.MethodsA pilot inspection study using a prototype borescope (SteriCam Inspection Scope, SteriView Inc, San Rafael, Calif) was performed on routinely used endoscopes after high-level disinfection, manual forced air dry of the instrument channel, and overnight vertical storage. Video recordings 1.5 to 2 minutes in duration were reviewed for visible moisture, debris, discoloration, scratches, channel shredding (scratches that result in strips or filaments of the channel lining protruding into the lumen), and visible evidence of biofilm or simethicone residue.ResultsA total of 97 inspections of 59 endoscopes were reviewed. The most common finding was scratches, seen in 51 devices (86%). Channel shredding was found in 35 devices (59%). Intra-channel debris was identified in 22 (23%) of the 97 inspections. No moisture was seen (0%) in the 74 inspections performed after forced air dry and overnight vertical storage compared with moisture in 5 of 18 inspections (28%) performed after storage alone. No visual evidence of biofilm or simethicone residue was discovered despite its frequent use in our unit.ConclusionInternal defects of the instrument channel appear to occur frequently. Manual forced air drying of the channel appears highly effective in eliminating moisture compared with overnight hang drying alone. Video inspection of the endoscope channel may be useful to audit reprocessing performance and to identify damaged endoscopes.
Technical feasibility and oncological safety of diagnostic endoscopic resection for superficial esophageal cancer Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-05-08 Masashi Takeuchi, Koichi Suda, Yasuo Hamamoto, Motohiko Kato, Shuhei Mayanagi, Kayo Yoshida, Kazumasa Fukuda, Rieko Nakamura, Norihito Wada, Hirofumi Kawakubo, Hiroya Takeuchi, Naohisa Yahagi, Yuko Kitagawa
Background Active use of endoscopic resection (ER) for cM3-SM2 esophageal cancer may enable sufficient extent of esophageal resection and help determine the need for lymph node dissection based on histopathological findings. However, ER preceding esophagectomy may have an adverse impact on outcomes. This study was designed to determine the technical feasibility and oncological safety of diagnostic ER. Methods A single-institution retrospective cohort study was performed between July 2008 and June 2014. During this period, 135 consecutive patients with clinical T1a-M3N0M0, T1b-SM1N0M0, and T1b-SM2N0M0 primary esophageal cancer were referred to our division. Eight patients who underwent chemoradiothearpy as primary treatment were excluded because of inadequate pathological findings. Based on oncological and physical factors, we categorized the remaining 127 patients into two groups: primary esophagectomy (n=54) and primary ER (n=73). Results In all 127 patients, the 3-year overall survival (OS) and disease-free survival (DFS) rates were 95.7% and 87.6%, respectively. No adverse event requiring surgical intervention was observed after ER. Diagnostic ER had no negative impact on surgical outcomes, DFS, and OS after esophagectomy. Fourteen patients (19.2%) of those who received primary ER underwent curative resection, whereas 11 (20.4%) who had pT1a disease, no lymphovascular invasion, and no pathological lymph node metastasis underwent primary esophagectomy. Conclusions Diagnostic ER for cM3-SM2 esophageal cancer with or without subsequent esophagectomy was feasible and safe from not only surgical but also oncological perspective. Approximately 20% of cM3-SM2N0M0 patients can potentially avoid undergoing additional treatment including esophagectomy using diagnostic ER.
A novel submucosal injection solution for endoscopic resection of large colorectal lesions: a randomized, double-blind trial Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-05-08 Alessandro Repici, Michael Wallace, Prateek Sharma, Pradeep Bhandari, Gianluca Lollo, Roberta Maselli, Cesare Hassan, Douglas K. Rex
Background SIC-8000 (Eleview) is a new FDA-approved solution for submucosal injection developed to provide long-lasting cushion to facilitate endoscopic resection maneuvers. Our aim was to compare the efficacy and safety of SIC-8000 with those of saline solution, when performing endoscopic mucosal resection (EMR) of large colorectal lesions. Methods In a randomized double-blind trial, patients undergoing EMR for ≥20 mm colorectal non-pedunculated lesions were randomized in a 1:1 ratio between SIC-8000 and saline solution as control solution in 5 tertiary centers. Endoscopists and patients were blinded to the type of submucosal solution used. Total volume to complete EMR and per lesion size and time of resection were primary end-points, whereas the Sydney Resection Quotient (SRQ), as well as other EMR outcomes, and the rate of adverse events were secondary. A 30-day telephone follow up was performed. An alpha level <0.05 was considered as statistically significant (NCT 02654418). Results Of the 327 patients screened, 226 (mean age: 66±10; males: 56%) were enrolled in the study and randomized between the 2 submucosal agents. Of these, 211 patients (mean size of the lesions 33±13 mm; I-s: 36%; proximal colon: 74%) entered in the final analysis (SIC-8000: 102; saline solution: 109). EMR was complete in all cases. The total volume needed for EMR was significantly less in the SIC-8000 arm compared with saline solution (16.1±9.8 mL vs 31.6±32.0 mL; p<0.001). This corresponded to an average volume per lesion size of 0.5±0.3 mL/mm and 0.9±0.6 mL/mm with SIC-8000 and saline solution, respectively, (p<0.001). The mean time to completely resect the lesion tended to be lower with SIC-8000 as compared with saline solution (19.1±16.8 minutes vs 29.7±68.9 minutes; p=0.1). The SRQ was significantly higher with SIC-8000 as compared with saline solution (10.3±8.1 vs 8.0±5.7; p=0.04) with a trend for a lower number of resected pieces (5.7±6.0 vs 6.5±5.04; p=0.052) and a higher rate of en bloc resections (19/102, 18.6% vs 12/111, 11.0%; p=0.1). The rate of adverse events was similar between the 2 arms (SIC-8000: 18.6%, saline solution: 17%), and none of the serious adverse events (SIC-8000: 8.8%; saline solution: 10.7%) was related with study treatment. Conclusions In a double-blind, randomized clinical trial, a new FDA approved agent for sub-mucosal injection appeared to be a more effective and equally safe submucosal agent for EMR injection than saline solution.
Comparison of endoscopic submucosal dissection and surgery for superficial esophageal squamous cell carcinoma: A propensity score-matched analysis Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-05-08 Yang Won Min, Hyuk Lee, Byeong Geun Song, Byung-Hoon Min, Hong Kwan Kim, Yong Soo Choi, Jun Haeng Lee, Na-Young Hwang, Keumhee C. Carriere, Poong-Lyul Rhee, Jae J. Kim, Jae Ill Zo, Young Mog Shim
Background and Aims Endoscopic submucosal dissection (ESD) has been widely accepted for treating superficial esophageal squamous cell carcinoma (SESCC). However, long-term outcomes of ESD and esophagectomy for SESCC have not been compared. We compared the clinical outcomes of ESD and esophagectomy in a matched cohort. Methods Patients who underwent ESD and esophagectomy for SESCC were included. We selected SESCCs without obvious submucosal invasion from the surgical database by reviewing endoscopic images. To minimize the effect of selection bias, propensity score matching was performed. Overall survival (OS), disease-specific survival (DSS), recurrence-free survival (RFS), and metachronous RFS were compared between the 2 groups. Adverse event rates were also compared. Results In a matched cohort of 120 pairs, OS, DSS, and RFS were comparable between the 2 groups. The 5-year OS, DSS, and RFS rates were 93.9% versus 91.2%, 100% versus 97.4%, and 92.8% versus 95.3% for the ESD and esophagectomy groups, respectively. The metachronous RFS was worse in the ESD group than in the esophagectomy group (P = .004). The 5-year metachronous RFS rates were 90.3% versus 100% for the ESD and esophagectomy groups, respectively. The esophagectomy group showed a higher overall adverse event rate than the ESD group (55.5% vs 18.5%, P < .0001). In each subgroup of mucosal and submucosal cancer, OS, DSS, and RFS were also comparable between the 2 groups. Conclusions ESD provides long-term outcomes comparable to esophagectomy in patients with SESCC without endoscopic evidence of obvious submucosal invasion. ESD should be considered as the first-line treatment for these patients.
Liquid nitrogen spray cryotherapy for dysphagia palliation in patients with inoperable esophageal cancer Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-05-08 Toufic Kachaamy, Ravi Prakash, Madappa Kundranda, Raman Batish, Jeffrey Weber, Scott Hendrickson, Leon Yoder, Hannah Do, Theresa Magat, Rajeev Nayar, Digant Gupta, Trisha DaSilva, Ashish Sangal, Shivangi Kothari, Vivek Kaul, Pankaj Vashi
Background and Aims Dysphagia is a debilitating symptom in patients with inoperable esophageal cancer contributing to poor quality of life and worsening nutritional status. The 2 most commonly used palliative modalities for dysphagia are radiation therapy (RT) and esophageal stent placement. However, RT is limited by adverse events (AEs) and total dose, and stent placement has a high rate of AEs including reflux, migration, and chest pain. A relatively new modality of liquid nitrogen endoscopic spray cryotherapy has been described as salvage when other options have been exhausted and when patients are no longer receiving systemic therapy. We evaluated the safety and efficacy of cryotherapy as the primary modality for relieving dysphagia in inoperable esophageal cancer including patients receiving systemic cancer therapy. Methods This is a retrospective multicenter consecutive case series of 49 inoperable esophageal cancer patients undergoing palliative endoscopic cryotherapy at 4 specialized cancer centers from May 2014 to May 2016. The primary outcomes were change in dysphagia scores between pre- and post-cryotherapy and AE. Dysphagia was measured using a 4-point Likert scale: 0, no dysphagia; 1, dysphagia to solids; 2, dysphagia to semi-solids; 3, dysphagia to liquids; 4, dysphagia to saliva. Results There were 39 males and 10 females with a mean age of 58 years who underwent a total of 120 cryotherapy treatments. The mean dysphagia score improved significantly from 2.4 pre-cryotherapy to 1.7 post-cryotherapy (improvement of 0.7 points; p<0.001). Minor AE were seen in 6/120 (5.0%) cryotherapy treatments (1 intra-procedural and 5 post-procedural). In addition, one patient developed a severe intra-procedural AE of dilation-related perforation whereas another patient developed a benign stricture requiring dilation. Conclusions This preliminary retrospective study suggests that liquid nitrogen spray cryotherapy may be safe and effective for dysphagia palliation in inoperable esophageal cancer. Large prospective studies are needed to confirm these findings and identify patient and procedure characteristics associated with the greatest benefit.
An international, multicenter, comparative trial of EUS-guided gastrogastrostomy-assisted ERCP versus enteroscopy-assisted ERCP in patients with Roux-en-Y gastric bypass anatomy Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-05-03 Majidah Bukhari, Thomas Kowalski, Jose Nieto, Rastislav Kunda, Nitin K. Ahuja, Shayan Irani, Apeksha Shah, David Loren, Olaya Brewer, Omid Sanaei, Lea Fayad, Yen-I. Chen, Saowanee Ngamruengphong, Vivek Kumbhari, Vikesh Singh, Hanaa Dakour Aridi, Mouen A. Khashab
Background & Aims ERCP is challenging in patients with Roux-en-Y gastric bypass (RYGB) anatomy. EUS-guided gastrogastrostomy (GG) creation is a promising novel technique to access the excluded stomach in order to facilitate conventional ERCP. We aimed to compare procedural outcomes and adverse events (AEs) between EUS-guided gastrogastrostomy-assisted ERCP (EUS-GG-ERCP) and enteroscopy assisted ERCP (e-ERCP) in patients with RYGB. Methods Patients with RYGB anatomy who underwent EUS-GG-ERCP or e-ERCP between 2014 and 2016 at 5 tertiary centers were included. The primary outcome was technical success of ERCP, defined as successful cannulation of the selected duct with successful intervention as intended. Secondary outcomes included (1) total procedural time (in the EUS-GG group, total procedural time included EUS-GG creation plus ERCP procedure time); (2) length of hospital stay; and (3) rate/severity of AEs graded according to the ASGE lexicon. Results A total of 60 patients (mean age 57.2 ±13.2, 75% female) were included, of whom 30 (50%) underwent EUS-GG-ERCP and 30 (50%) underwent e-ERCP (DBE-ERCP 19 and SBE-ERCP 11). The technical success rate was significantly higher in the EUS-GG-ERCP versus the e-ERCP group (100% vs 60.0%, p <0.001). Total procedure time was significantly shorter in patients who underwent EUS-GG-ERCP (49.8 min vs 90.7 min, p<0.001). Postprocedure median length of hospitalization was shorter in the EUS-GG group (1 vs 10.5 days, p=0.02). Rate of AEs was similar in both groups (10% vs 6.7%, p=1). Conclusion EUS-GG-ERCP may be superior to e-ERCP in patients with RYGB anatomy in terms of a higher technical success and shorter procedural times and offers a similar safety profile.
EUS-Guided Hepaticoenterostomy as a portal to allow definitive antegrade treatment of benign biliary diseases in patients with surgically altered anatomy Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-05-03 Theodore W. James, Y. Claire Fan, Todd H. Baron
Background & Aims EUS-guided hepaticoenterostomy (EUS-HE) is usually reserved for palliation of malignant biliary obstruction after failed endoscopic retrograde cholangiography (ERC) or inaccessible biliary tree in surgically altered anatomy (SAA). We describe outcome of EUS-HE and antegrade therapy for benign biliary disease in patients with SAA. Methods Retrospective review of 20 consecutive patients with surgically altered anatomy and benign biliary obstruction who underwent EUS-HE performed by one endoscopist at a tertiary center over a three-year period. Results During the study period, 37 patients underwent EUS-HE, 24 for benign disease. Of these, 20 patients had SAA and were analyzed (15 females, mean age, 62 years). SAA consisted of 9 Roux-en-Y Gastric Bypass, 6 Roux-en-Y Hepaticojejunostomy, 2 Billroth II, and 3 Whipple. Indications for ERC were common bile duct stone (8), benign postsurgical stricture (7), chronic pancreatitis (3), inflammatory stricture (1) and treatment of bile leak (1). Five patients had previously failed balloon enteroscopy-assisted ERC. The approach was transgastric in 15 and transjejunal in 5. In all cases a branch of the left hepatic duct with a mean diameter of 7.8 mm was accessed. Median stent length was 80 mm with diameters of 8 or 10 mm. Antegrade, definitive endoscopic therapy via the HE was performed in 18 patients with an average of 2.7 procedures performed for resolution of stones and/or downstream strictures. HE stents were removed in 17 patients after a mean of 91 days without adverse events. Three patients experienced mild adverse events (one with postprocedural pancreatitis after placement of a 10F transpapillary stent, one with postprocedural abdominal pain, and one with postprocedural cholangitis) requiring hospitalization for less than 3 nights; no severe adverse events occurred. Average postprocedural hospital stay was 1.3 days. No deaths occurred during follow-up. Conclusions EUS-guided hepaticoenterostomy is safe and effective in the management of benign biliary obstruction in patients with surgically-altered anatomy. It creates a portal to allow definitive, antegrade therapy and is a viable alternative to other endoscopic methods in this patient population.
A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-04-30 Douglas K. Rex, Raj Bhandari, Taddese Desta, Michael DeMicco, Cynthia Schaeffer, Kyle Etzkorn, Charles Barish, Ronald Pruitt, Brooks D. Cash, Daniel Quirk, Felix Tiongco, Shelby Sullivan, David Bernstein
Background Remimazolam is an ultrashort-acting benzodiazepine. Methods We performed a randomized double-blind comparison of remimazolam to placebo for outpatient colonoscopy. This study design was a requirement of the U.S. Food and Drug Administration. An additional group was randomized to open-label midazolam administered according to its package insert instructions (randomization ratio for remimazolam:placebo:midazolam was 30:6:10). Study medications were administered under the supervision of the endoscopist, without any involvement of an anesthesia specialist. Patients were given 50 to 75 μg of fentanyl before receiving study medications. Patients who failed to achieve adequate sedation in any arm were rescued with midazolam dosed at the investigator’s discretion. The primary endpoint was a composite that required 3 criteria be met: completion of the colonoscopy, no need for rescue medication, and ≤5 doses of remimazolam or placebo in any 15-minute interval (≤3 doses of midazolam in any 12-minute interval in the open-label midazolam arm). Results There were 461 randomized patients in 12 U.S. sites. The primary endpoint was met for remimazolam, placebo, and midazolam in 91.3%, 1.7%, and 25.2% of patients, respectively (P< 0.0001 for remimazolam vs placebo). Patients administered remimazolam received less fentanyl, had faster recovery of neuropsychiatric function, were ready for discharge faster, and felt back to normal faster than patients with both placebo and midazolam. Hypotension was less frequent with remimazolam and hypoxia occurred in 1% of subjects with remimazolam or midazolam. There were no treatment-emergent serious adverse events. Conclusion Remimazolam can be safely administered under the supervision of endoscopists for outpatient colonoscopy and allows faster recovery of neuropsychiatric function compared with placebo (midazolam rescue) and midazolam.
Transplantation of autologous esophageal mucosa to prevent stricture after circumferential endoscopic submucosal dissection of early esophageal cancer (with video) Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-04-25 ZhongLi Liao, GuoBin Liao, Xin Yang, Xue Peng., Xia Zhang, Xia Xie, XiaoYan Zhao, ShiMing Yang, ChaoQiang Fan, JianYing Bai
Backgroud and study aims Esophageal stricture is a common adverse event after endoscopic submucosal dissection (ESD) when it involves entire circumference of esophagus. We aimed to assess the effectiveness and safety of endoscopic transplantation of autologous esophageal mucosa in preventing stricture formation after circumferential ESD. Patients and methods Nine patients who underwent circumferential ESD for early esophageal cancer were enrolled. After undergoing ESD, autologous esophageal mucosal patches were attached to the “ulcer surface” using hemoclips and then fixed with a covered metal mesh stent. The stent was removed 7 days after the procedure. The patients were followed up with endoscopy at scheduled times. Results Epithelialization occurred within a median of 7.1 days with a graft survival rate of 96.5%. Strictures occurred at a mean of 24.7 days (range 18-34) after the procedure. The median number of endoscopic balloon dilatation (EBD) sessions was 2.7 (range 0–6). Conclusions Transplantation of autologous esophageal mucosa could be a safe way of relieving the severity of esophageal stricture after cESD.
The impact of chromoendoscopy for surveillance of the duodenum in patients with MUTYH-associated polyposis and familial adenomatous polyposis Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-04-24 Joanna J. Hurley, Laura E. Thomas, Sarah-Jane Walton, Siwan Thomas-Gibson, Adam Haycock, Noriko Suzuki, Matthew Mort, Geraint Williams, Meleri Morgan, Susan K. Clark, Julian R. Sampson, Sunil Dolwani
Background and Aims Duodenal polyposis and cancer have become a key issue for patients with familial adenomatous polyposis (FAP) and MUTYH-associated polyposis (MAP). Almost all patients with FAP will develop duodenal adenomas, with 5% developing cancer. The incidence of duodenal adenomas in MAP appears to be lower than in FAP but the limited available data suggest a comparable increase in the relative risk and lifetime risk of duodenal cancer. Current surveillance recommendations, however, are the same for FAP and MAP, using the Spigelman score--incorporating polyp number, size, dysplasia, and histology--for risk stratification and determination of surveillance intervals. Previous studies have demonstrated a benefit of enhanced detection rates of adenomas by use of chromoendoscopy both in sporadic colorectal disease and in groups at high risk of colorectal cancer. We aimed to assess the effect of chromoendoscopy on duodenal adenoma detection, to determine the impact on Spigelman stage and to compare this in individuals with known pathogenic mutations in order to determine the difference in duodenal involvement between MAP and FAP. Methods A prospective study examined the impact of chromoendoscopy on the assessment of the duodenum in 51 consecutive patients with MAP and FAP in 2 academic centers in the United Kingdom (University Hospital Llandough, Cardiff and St Mark's Hospital, London) from 2011 to 2014. Results Enhanced adenoma detection of 3 times the number of adenomas after chromoendoscopy was demonstrated in both MAP (p=0.013) and FAP (p=0.002), but did not affect adenoma size. In both conditions, there was a significant increase in Spigelman stage after chromoendoscopy compared with endoscopy without dye spray. Spigelman scores and overall adenoma detection was significantly lower in MAP compared with FAP. Conclusions Chromoendoscopy improved the diagnostic yield of adenomas in MAP and FAP 3-fold, and in both MAP and FAP this resulted in a clinically significant upstaging in Spigelman score. Further studies are required to determine the impact of improved adenoma detection on the management and outcome of duodenal polyposis.
Use of diphenhydramine as an adjunctive sedative for colonoscopy in patients on chronic opioid therapy: a randomized controlled trial Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-04-22 Salman Nusrat, Mohammed F. Madhoun, William M. Tierney
Background and Aims Chronic opioid use increases tolerance to sedatives. Diphenhydramine is recommended for difficult-to-sedate patients during endoscopic procedures. We hypothesized that the addition of diphenhydramine to midazolam and fentanyl would improve objective and subjective measures of procedural sedation. Methods This randomized, double-blind, placebo-controlled trial included patients on chronic opioids undergoing colonoscopy. Patients were randomized to receive intravenous 50 mg of diphenhydramine (N=61) or placebo (N=58), in addition to fentanyl and midazolam. Baseline characteristics, amount of fentanyl and midazolam, procedure times, and adverse events were recorded. Quality of sedation was assessed by the physician and nurse. Patients rated pain and amnesia on a 10-point scale. Results There was no difference in amounts of fentanyl (125.4 ± 56.2 μg vs 126.9 ± 53.5 μg, p=0.88) and midazolam (4.9 ± 2.1 mg vs 5 ± 1.9 mg, p=0.79) used. The mean sedation scores from the physician (6.2 ± 1.1 vs 5.3 ± 1.2, p=0.0002) and nurses (5.6 ± 1.5 vs 5.1 ± 1.4, p=0.04) were statistically significant in favor of the diphenhydramine arm. Patient scores for pain (2.05 ± 2.17 vs 3.09 ± 3.95, p=0.047) and amnesia (7.8 ± 3.4 vs 6.5 ± 3.8, p=0.047) favored the group that received diphenhydramine. Qualitative assessment showed no significant difference between groups. There was no difference in induction time (p=0.86), procedure duration (p=0.98), or recovery time (p=0.16). Hypotensive episodes were more common in the placebo group (p=0.027). Conclusions In patients on chronic opioid therapy, administration of diphenhydramine does not allow for lower doses of procedural sedatives but improves quality of sedation without increasing the number of adverse events.
Valuing innovative endoscopic techniques: per-oral endoscopic myotomy for the management of achalasia Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-04-21 Eric D. Shah, Andrew C. Chang, Ryan Law
Background and Aims Unclear reimbursement for new and innovative endoscopic procedures can limit adoption in clinical practice despite effectiveness in clinical trials. The aim of this study was to determine maximum cost-effective reimbursement for per-oral endoscopic myotomy (POEM) in treating achalasia. Methods We constructed a decision analytic model assessing POEM versus laparoscopic Heller myotomy with Dor fundoplication (LHM) in managing achalasia from a payer perspective over a 1-year time horizon. Reimbursement data were derived from 2017 Medicare data. Responder rates were based on clinically meaningful improvement in validated Eckardt scores. Validated health utility values were assigned to terminal health states based on data previously derived with a standard gamble technique. Contemporary willingness-to-pay (WTP) levels per quality-adjusted life year (QALY) were used to estimate maximum reimbursement for POEM using threshold analysis. Results Effectiveness of POEM and LHM was similar at one year of follow-up (0.91 QALY). Maximum cost-effective reimbursement for POEM was $1,200.07 to $1,389.85 (33.4-38.7 total 2017 RVUs). This compares to contemporary total reimbursement of 10-15 total RVU for advanced endoscopic procedures. The model was most sensitive to the probability of GERD after procedure. The rate of conversion to open laparotomy due to perforation or bleeding was infrequent in published clinical practice experience, thus did not significantly affect reimbursement. Conclusion POEM is an example of an innovative and potentially disruptive endoscopic technique offering greater cost-effective value and similar outcomes to the established surgical standard at contemporary reimbursement levels.
Duodenoscope reprocessing practice patterns in U.S. endoscopy centers: a survey study Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-04-21 Adarsh M. Thaker, V. Raman Muthusamy, Alireza Sedarat, Rabindra R. Watson, Michael L. Kochman, Andrew S. Ross, Stephen Kim
Background and Aims After recent outbreaks of duodenoscope-related infections from multidrug-resistant organisms (MDRO), the United States Food and Drug Administration (FDA) recommended implementing one or more of four enhanced reprocessing measures in addition to updated manual cleaning methods and high-level disinfection (HLD). The implementation of these techniques in endoscopy facilities and provider opinions regarding reprocessing priorities remain unknown. Methods Physicians, nurse managers, nurses, and infection control staff at endoscopy units performing ERCP in the United States were surveyed to assess current institutional practices and individual opinions regarding future reprocessing solutions. Results A total of 249 distinct institutions participated in the survey. Of these, 223 (89.6%) implemented at least 1 of the 4 supplemental reprocessing methods after MDRO outbreaks. Overall, 63% of centers used repeat HLD, 53% performed surveillance microbiological culturing, 35% used liquid chemical sterilization, and 12% used ethylene oxide sterilization. Thirty-seven centers (15%) routinely screened patients for MDRO. Forced air drying after reprocessing was used by 47.8% of centers. Fifty percent of individual respondents, including 58.6% of physicians, believed that redesign of the duodenoscope is the best long-term reprocessing solution. The majority (55.1%) identified efficacy to be the single most important factor in selecting a reprocessing technique. Conclusions Although the vast majority of endoscopy centers have implemented enhanced duodenoscope reprocessing techniques, there is a large variation in practice. Most providers believe that duodenoscope redesign and identifying reprocessing techniques with maximal efficacy are the long-term priorities. Improved adherence to forced air drying in duodenoscope reprocessing is needed.
Newly developed endoscopic detachable snare ligation therapy for colonic diverticular hemorrhage: a multicenter phase II trial (with videos) Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-04-19 Daisuke Akutsu, Toshiaki Narasaka, Katsumasa Kobayashi, Kenji Matsuda, Mariko Wakayama, Yoshinori Hiroshima, Shinji Endo, Takashi Mamiya, Takahisa Watahiki, Kazuto Ikezawa, Hiroyasu Ishida, Mitsuaki Hirose, Yuji Mizokami, Ichinosuke Hyodo
Background and Aims We previously reported preliminary safety results for a new method, endoscopic detachable snare ligation (EDSL), for diverticular hemorrhage. This method does not need endoscope removal to attach a ligation device after detection of the bleeding site. The aim of the present study was to evaluate the efficacy and safety of EDSL in a larger patient population. Methods This prospective study was conducted in 12 institutions. Patients suspected of having diverticular hemorrhage without serious systemic disease were enrolled. The primary endpoint was early (within 30 days) recurrent bleeding rate in patients treated with EDSL. The secondary endpoints were overall early recurrent bleeding rate in patients with definite diverticular bleeding and adverse events in patients treated with EDSL. Results From June 2015 to March 2017, bleeding diverticula were detected in 123 (60%) of 205 enrolled patients, of whom 101 (82%) were treated with EDSL. Most patients (n=20/22) in whom EDSL was not successful were treated with clipping. The early recurrent bleeding rate was 7.9% (95% confidence interval [CI], 2.6%-13.2%; n=8/101) in patients who could be treated with EDSL. The median total endoscopic and EDSL procedure time was 40 (interquartile range [IQR] 15–71) and 4 (IQR 1–7) minutes, respectively. Two mild adverse events, colonic diverticulitis and temporary abdominal pain, were observed. Conclusions EDSL was confirmed to be useful and safe for treatment of colonic diverticular hemorrhage.
Impact of Fellowship Training Level on Colonoscopy Quality and Efficiency Metrics Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-04-19 Hussein Bitar, Hassaan Zia, Muhammad Bashir, Pratyusha Parava, Muhammad Hanafi, William Tierney, Mohammad Madhoun
Background & Aims Previous studies have described variable effects of fellow involvement on the adenoma detection rate (ADR), but few have stratified this effect by level of training. We aimed to evaluate the “fellow effect” on multiple procedural metrics including a newly defined adenoma management efficiency index, which may have a role in documenting colonoscopy proficiency for trainees. We also describe the impact of level of training on moderate sedation use. Methods We performed a retrospective review of 2024 patients (mean age 60.9 ± 10. 94% males) who underwent outpatient colonoscopy between June 2012 and December 2014 at our Veterans Affairs Medical Center. Colonoscopies were divided into 5 groups. The first 2 groups were first year fellows in the first 6 months and last 6 months of the training year. Second and third year fellows and attending only procedures accounted for one group each. We collected data on doses of sedatives used, frequency of adjunctive agent use, procedural times as well as location, size and histology of polyps. We defined the adenoma management efficiency index as average time required per adenoma resected during withdrawal. Results 1675 colonoscopies involved a fellow. 349 were performed by the attending alone. There was no difference in ADR between fellows according to level of training (P=0.8), or between fellows compared with attending-only procedures (P=0.67). Procedural times decreased consistently during training, and declined further for attending only procedures. This translated into improvement in the adenoma management efficiency index (fellow groups by ascending level of training 23.5 minutes vs 18.3 minutes vs 13.7 minutes vs 13.4 minutes vs attending group 11.7 minutes; P<0.001). There was no difference in the average doses of midazolam and fentanyl used among fellow groups (P=0.16 and P=0.1, respectively). Compared with attending-only procedures, fellow involvement was associated with higher doses of fentanyl and midazolam and more frequent use of diphenhydramine and glucagon (P<0.0001; P=0.0002; P<0.0001; and P=0.01, respectively). Conclusions ADR was similar at different stages of fellowship training and comparable with the attending group. Efficiency of detecting and resecting polyps improved throughout training without reaching attending level. Fellow involvement led to greater use of moderate sedation, which may relate to a longer procedure duration and an evolving experience in endoscopic technique.
Water-pocket endoscopic submucosal dissection for superficial gastric neoplasms (with video) Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-04-13 Hideaki Harada, Daisuke Murakami, Satoshi Suehiro, Ryotaro Nakahara, Tetsuro Ujihara, Ryota Sagami, Yasushi Katsuyama, Kenji Hayasaka, Yuji Amano
Background and Aims During endoscopic submucosal dissection (ESD), a clear view is essential for precise dissection of the appropriate submucosal layer. Some advantages have been reported for underwater techniques of endoscopic resection in comparison with the gas insufflation method. We have developed a new ESD method with the creation of a local water-pocket that provides a clear view in the dissection field. Therefore, we aimed to investigate the feasibility and safety of water-pocket ESD (WP-ESD) for superficial gastric neoplasms. Methods We prospectively recruited 50 patients with gastric neoplasms (early gastric cancer or gastric adenomas) between April 2017 and December 2017. Among them, 48 patients were treated with the WP-ESD technique. The patients undergoing WP-ESD were compared with 48 patients treated with standard ESD (S-ESD) who were selected by propensity score matching. The primary outcome was the ESD procedure time. Results Total procedure time was significantly shorter in the WP-ESD group than in the S-ESD group (median [IQR], 27.5 [19-45] min vs 41 [29.8-69] min; P < 0.001). Similarly, the dissection speed was significantly greater in the WP-ESD group than in the S-ESD group (median [IQR], 22.5 [16.8-35.3] mm2/min vs. 17.3 [12.7-22.1] mm2/min; P < 0.001). The rates of complete en bloc resection in the WP-ESD group and the S-ESD group were 97.9% and 95.8%, respectively (P > 0.99). There were no perforations in either group. Conclusions WP-ESD was associated with a shorter procedure time than S-ESD. WP-ESD may provide an alternative method for resection of superficial gastric neoplasms.
Reliability among central readers in the evaluation of endoscopic disease activity in pouchitis Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-04-13 Mark A. Samaan, Bo Shen, Mahmoud H. Mosli, Guangyong Zou, William J. Sandborn, Lisa M. Shackelton, Sigrid Nelson, Larry Stitt, Stuart Bloom, Darrell S. Pardi, Paolo Gionchetti, James Lindsay, Simon Travis, Ailsa Hart, Mark S. Silverberg, Brian G. Feagan, Geert R. D’Haens, Vipul Jairath
Background & Aims Pouchitis is a common adverse event after proctocolectomy with ileal pouch anal anastomosis for ulcerative colitis. Evaluation of pouchitis disease activity and response to treatment requires use of validated indices. We assessed the reliability of items evaluating endoscopic pouchitis disease activity. Methods Twelve panelists used a modified RAND appropriateness methodology to rate the appropriateness of items evaluating endoscopic pouchitis disease activity derived from a systematic review, and also identified additional potential endoscopic items based on expert opinion. Four central readers then evaluated 50 pouchoscopy videos in triplicate, in random order. Intra- and inter-rater reliability for each item was assessed by calculating and comparing intra-class correlation coefficients (ICCs). A Delphi process identified common sources of disagreement among the readers. Results Ten existing endoscopic items were identified from the systematic review and an additional 7 exploratory items from the panelists. Intra-class correlation coefficients (95% confidence interval [CI]) for inter-rater reliability were highest for the existing item of pouch ulceration (0.72; 95% CI, 0.60-0.82) and for the exploratory item of ulcerated surface in the pouch body (0.67; 95% CI, 0.53-0.75). Inter-rater reliability for all other existing and exploratory items was “moderate” (ICC<0.60). The item ulcerated surface in the pouch body demonstrated the best correlation with a global evaluation of lesion severity (r=0.80; 95% CI, 0.73-0.85). Conclusion Substantial reliability was observed only for the endoscopic items of ulceration and ulcerated surface in the pouch body. Future studies should assess responsiveness to treatment in the next stage toward development of an endoscopic pouchitis disease activity index.
Efficacy and safety of endobiliary radiofrequency ablation for the eradication of residual neoplasia after endoscopic papillectomy : a multicenter prospective study Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-04-13 Marine Camus, Bertrand Napoléon, Ariane Vienne, Marc Le Rhun, Sarah Leblanc, Maximilien Barret, Stanislas Chaussade, Françoise Robin, Nadira Kaddour, Frederic Prat
Background and study aims: Endobiliary dysplasia may persist after endoscopic papillectomy. Intraductal radiofrequency ablation (ID-RFA) is a potential alternative to complementary surgery. The aim of the study was to evaluate the efficacy and safety of ID-RFA for the treatment of adenomatous intraductal residue after endoscopic papillectomy. Patients and methods A prospective open-label multicenter study included patients with histologically proven endobiliary adenoma remnant (ductal extent <20 mm), after endoscopic papillectomy for ampullary tumor. RFA (effect 8, power 10 Watts, 30s) was performed during ERCP. Biliary ± pancreatic stent was placed at the end of the procedure. Endpoints were (1) the rate of residual neoplasia (ie, low-grade dysplasia-LGD, high-grade dysplasia-HGD, or invasive carcinoma) at 6 and 12 months; (2) rate of surgery, and (3) adverse events. Results Twenty patients (67 years (±11), 12 men) were included. The endobiliary adenoma was in LGD in 15 patients, and HGD in 5 patients. All underwent one successful ID-RFA session with biliary stent placement and recovered uneventfully. Five (25%) received a pancreatic stent. The rates of residual neoplasia were 15% and 30% at 6 and 12 months, respectively. Only 2 patients (10%) were referred for surgery. Eight patients (40%) experienced at least 1 adverse event between ID-RFA and 12 months of follow-up. No major adverse event occurred. HGD at inclusion was associated with higher dysplasia recurrence at 12 months (p=0.01). Conclusions ID-RFA of residual endobiliary dysplasia after endoscopic papillectomy can be offered as an alternative to surgery, with a 70% chance of dysplasia eradication at 12 months after a single session and a good safety profile. Patient follow-up remains warranted after ID-RFA. ClinicalTrial.gov identifier: NCT02825524
Covered versus uncovered self-conformable metal stent for palliation of primary malignant extrahepatic biliary strictures: a randomized multicenter study Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-04-11 Massimo Conio, Benedetto Mangiavillano, Angelo Caruso, Rosa Angela Filiberti, Todd H. Baron, Luca De Luca, Sergio Signorelli, Mattia Crespi, Mario Marini, Paolo Ravelli, Rita Conigliaro, Antonella De Ceglie
Background and Aims Self-expandable metal stents (SEMSs) are used to relieve malignant biliary obstruction. We aimed to compare stent patency, adverse events rate and overall survival of covered (Niti-S Biliary ComVi) versus uncovered (Niti-s D type) self-conformable metal stents in patients with primary malignant extrahepatic biliary stricture, not eligible for surgery. Methods This is a multicenter randomized trial analyzing 158 patients with inoperable distal malignant biliary obstruction conducted in 5 Italian referral centers between December 2014 and October 2016. Seventy-eight patients were randomized to receive a fully covered SEMS (FCSEMS) and 80 uncovered SEMSs (USEMSs). Data from 148 (72 FCSEMSs and 76 USEMSs) out of 158 patients were analyzed. Results Median time of stent patency was lower for FCSEMSs (240 days vs 541 days for USEMSs; p=0.031). Adverse events occurred in 19 FCSEMSs (26.4%) and 10 USEMSs (13.2%), p=0.061. The main causes of FCSEMS dysfunction were migration (7% vs 0% in the USEMS group) and early occlusion mainly due to sludge or overgrowth; late stent occlusion due to tumor ingrowth occurred in 13.2% in the USEMS group. There were no significant differences either in levels of conjugated bilirubin improvement or in overall survival between the FCSEMS and USEMS groups. Median survival was 134 days in the FCSEMS group and 112 days in the USEMS group (p=0.23). Conclusions Stent-related adverse events were higher, although not significantly, among FCSEMS patients. FCSEMSs had a significantly higher rate of migration than USEMSs and stent occlusion occurred earlier. A significant difference in patency rate was observed in favor of the USEMS group.
Multifocal nitrous oxide cryoballoon ablation with or without EMR for treatment of neoplastic Barrett’s esophagus Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-04-05 Marcia Irene Canto, Nicholas J. Shaheen, Jose Alejandro Almario, Lysandra Voltaggio, Elizabeth Montgomery, Charles J. Lightdale
Background and Aims Endoscopic cryotherapy can eradicate neoplastic Barrett’s esophagus (BE). A new contact cryoballoon focal ablation system (CbFAS)) freezes esophageal mucosa with nitrous oxide. We studied the safety and efficacy of CbFAS for complete eradication of neoplastic Barrett's esophagus. Methods In a prospective clinical trial, consecutive BE patients with confirmed neoplasia (low-grade dysplasia LGD, high-grade dysplasia HGD, and/or intramucosal adenocarcinoma ImCA), at least 1 cm of BE, with or without prior ablation, were treated with a dose 10 seconds of spray per site. EMR was performed for nodular lesions. Treatments were repeated every 10 to 12 weeks until complete eradication, with a maximum of 5. Primary outcomes were complete eradication of all dysplasia (CE-D) and intestinal metaplasia (CE-IM) at 1 year (intention-to-treat analysis). Results Forty-one evaluable patients (22 treatment-naïve, 19 previously ablated) with LGD (n=13), HGD (n=23) or ImCA (n=5) were treated. The median procedure time was 30 minutes. The median number of ablation procedures for CE-IM was 3 (IQ range 2-4). Overall 1-year CE-D and CE-IM rates were 95% and 88%, respectively. CE-D rate was significantly lower (67%) in those with ultra-long BE compared with those with <8 cm (100%, p=0.02). Median pain scores were zero at day 1. Four patients (9.7%) developed mild dysphagia from stenoses requiring dilation. One patient on aspirin developed upper GI bleeding, not requiring therapy. Conclusion Multifocal nitrous oxide cryotherapy using CbFAS is a promising, highly effective, and safe endoscopic treatment for primary or rescue therapy of BE-associated neoplasia and intestinal metaplasia. (ClinicalTrials.gov number NCT02534233)
Cost-Effectiveness Analysis Comparing Lumen Apposing Metal Stents with Plastic Stents in the Management of Pancreatic Walled-Off Necrosis Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-04-01 Yen-I. Chen, Alan N. Barkun, Viviane Adam, Ge Bai, Vikesh K. Singh, Majidah Bukhari, Olaya Brewer Gutierrez, B. Joseph Elmunzer, Robert Moran, Lea Fayad, Mohamad El Zein, Vivek Kumbhari, Alessandro Repici, Mouen A. Khashab
Background and Aims EUS-guided transmural drainage is effective in the management of pancreatic walled-off necrosis (WON). A lumen-apposing metal stent (LAMS) has recently been developed specifically for the drainage of pancreatic fluid collections showing promising results. However, no cost-effectiveness data have been published in comparison to endoscopic drainage with traditional plastic stents (PSs). The aim is to compare the cost-effectiveness of LAMSs to PSs in the management of WON. Methods A decision tree is developed assessing both LAMSs and PSs over a 6-month time horizon. For each strategy, after the insertion of the respective stents, patients are followed for subsequent need for direct endoscopic necrosectomy, adverse events requiring unplanned endoscopy, percutaneous drainage (PCD), or surgery using probabilities obtained from the literature. The unit of effectiveness is defined as successful endoscopic drainage without the need for PCD or surgery. Costs in 2016 U.S.$ are based on inpatient institutional costs. Sensitivity analyses are performed. An a priori willingness-to-pay threshold of U.S. $50,000 is established. Results LAMSs are more efficacious than PSs with 92% and 84% of the patients achieving successful endoscopic drainage of WON, respectively. LAMSs, however, are more costly: the average cost per patient of U.S. $20,029 compared with U.S. $15,941 for PSs. The incremental cost-effectiveness ratio favored LAMSs at U.S. $49,214 per additional patient successfully treated. Sensitivity analyses confirm the robustness of the results. Conclusion LAMSs are more effective but also more costly than PSs in managing WON. Data from high-quality adequately controlled prospective randomized trials are needed to confirm our findings.
Efficacy of EUS- and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-03-30 Joo Kyung Park, Young Sik Woo, Donghyo Noh, Ju-Il Yang, So Young Bae, Hwan Sic Yun, Jong Kyun Lee, Kyu Taek Lee, Kwang Hyuck Lee
Background and Aims ERCP-guided biliary drainage (ERCP-BD is a criterion standard treatment for malignant biliary obstruction when curative surgery is not an option. Alternative methods such as PTBD would significantly lower the quality of life. EUS-guided biliary drainage (EUS-BD) has been developed and performed by experienced endoscopists. Therefore, the aims of this study were to evaluate the efficacy and safety of EUS-BD compared with ERCP in malignant biliary obstruction. Methods The prospective randomized controlled study was conducted and 30 patients were enrolled; 15 for each EUS-BD and ERCP-BD arm. The technical success, procedural time, clinical success, and adverse events were evaluated. Results Thirty patients had extrahepatic malignant biliary tract obstruction (19 males, 11 females). Twenty-seven patients had unresectable PDACs, 1 patient had distal common bile duct (CBD) cancer, and 2 patients had metastatic malignant lymphadenopathy. There were no significant differences both in terms of technical success rate and clinical success rate; 100% versus 93% and 93% versus 100% in ERCP-BD versus EUS-BD, respectively (p=1.00, p=1.00). Four patients (31%) had tumor ingrowth-caused stent dysfunction in the ERCP-BD group, whereas 2 patients had food impaction and 2 patients had stent migration in the EUS-BD group. No significant procedure-related adverse events occurred in either group. Conclusions This prospective randomized controlled study suggests that EUS-BD has similar safety to ERCP-BD. EUS-BD was not superior to ERCP-BD in terms of relief of malignant biliary obstruction. EUS-BD may have fewer cases of tumor ingrowth but may also have more cases of food impaction or stent migration. (ClinicalTrials.gov number, NCT01421836.)
Efficacy and safety of endoscopic submucosal dissection for gastric neoplasms in patients with compensated liver cirrhosis: a propensity score–matched case-control study Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-03-28 Young Kwon Choi, Ji Yong Ahn, Do Hoon Kim, Kee Wook Jung, Hee Kyong Na, Kee Don Choi, Jeong Hoon Lee, Ho June Song, Gin Hyug Lee, Hwoon-Yong Jung
Background and Aims The clinical outcomes of endoscopic submucosal dissection (ESD) for gastric neoplasms in liver cirrhosis patients have not been adequately reported, leading to clinician concerns about adverse events, including bleeding and the deterioration of liver function. We compared the efficacy and safety of ESD between cirrhosis and noncirrhosis patients. Methods Between January 2005 and December 2014, 158 cirrhosis patients underwent ESD for gastric neoplasms at a tertiary medical institution. Their clinical outcomes were compared with those of a propensity score–matched control group (158 patients) selected from noncirrhosis patients, using age, sex, histology, tumor location, and lesion size as variables. Results En bloc resection (96.8%), curative resection (89.9%), and adverse event (bleeding [10.1%] and perforation [1.9%]) rates in the cirrhosis group did not differ significantly from those in the noncirrhosis group. The median procedure time (25.0 vs 23.0 minutes) was also comparable between the groups. In a survival analysis cirrhosis patients exhibited a significantly higher mortality risk than noncirrhosis patients (hazard ratio [HR], 3.52; 95% confidence interval [CI], 1.35-9.23; P = .01). Cirrhosis patients without hepatocellular carcinoma (HCC) showed no statistically significant difference in mortality compared with the noncirrhosis group (HR, 2.14; 95% CI, .72-6.39; P = .171). Three of 153 patients (2%) exhibited a deterioration of prognosis from Child-Pugh class A to B. Conclusions In compensated cirrhosis patients, especially those without HCC, ESD for gastric epithelial neoplasms can be performed with safety and efficacy comparable with that in noncirrhosis patients, without deterioration in liver function.
Higher incidence of metachronous advanced neoplasia in patients with synchronous advanced neoplasia and left-sided colorectal resection for colorectal cancer Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-03-21 Yohei Yabuuchi, Kenichiro Imai, Kinichi Hotta, Sayo Ito, Yoshihiro Kishida, Tomohiro Yamaguchi, Akio Shiomi, Yusuke Kinugasa, Masao Yoshida, Masaki Tanaka, Noboru Kawata, Naomi Kakushima, Kohei Takizawa, Hirotoshi Ishiwatari, Hiroyuki Matsubayashi, Hiroyuki Ono
Background and Aims There is an increased risk of developing metachronous colorectal cancer (CRC) in the remnant colorectum after surgical resection of CRC. We evaluated the incidence of metachronous advanced neoplasia (AN) after surgery for CRC according to resection type and synchronous AN. Methods This cohort study included patients who underwent surgical resection for initial CRC at a tertiary cancer center in Japan between September 2002 and December 2012. The cumulative probability of metachronous AN was calculated using the Kaplan-Meier method and was evaluated by the log-rank test. Results Metachronous AN was detected in 145 of the 1731 included patients, and the 5-year cumulative probability of metachronous AN was 13.1%. There was no significant difference in the incidence of metachronous AN in the right-sided colorectal resection (RCR) versus left-sided colorectal resection (LCR) groups (log-rank test P = 0.151), whereas the incidence of metachronous AN was significantly higher in patients with synchronous AN (log-rank test P < 0.001). In subgroup analysis of patients according to resection type and synchronous AN, the LCR group with synchronous AN showed a significantly higher incidence of metachronous AN than the other groups (log-rank test P < 0.001). Conclusions We found that synchronous AN, but not resection type, was independently associated with the incidence of metachronous AN in patients who underwent surgical resection of CRC. In addition, subjects with synchronous AN after LCR had a potentially increased risk for metachronous AN. Thus, it may be useful to perform risk stratification according to synchronous AN and resection type.
Stent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: a randomized trial (with videos) Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-03-21 Ji Young Bang, Udayakumar Navaneethan, Muhammad Hasan, Robert Hawes, Shyam Varadarajulu
Background and Aims Studies on EUS-guided transmural biliary drainage (EUS-BD) have evaluated its efficacy as a rescue technique after failed ERCP. We performed a single-center, single-blind, randomized trial to compare EUS-BD and ERCP as primary treatment for distal biliary obstruction in pancreatic cancer. Methods Patients underwent EUS-BD (n=33) or ERCP (n=34). The primary endpoint was the rate of adverse events. Secondary endpoints were technical success, treatment success (defined as decline in serum bilirubin by 50% at 2-week follow-up), reinterventions and intraoperative technical outcome, when applicable. Follow-up was until death or minimum of 6 months. Results The rates of adverse events were 21.2% (6.1% moderate severity; others mild severity) in the EUS-BD group and 14.7% (5.9% moderate severity; others mild severity) in the ERCP group (risk ratio 0.69; 95% confidence interval, 0.24-1.97; p=0.49). There were no procedure-related deaths. There was no significant difference in the rates of technical success (90.9% vs 94.1%, p=0.67), treatment success (97 vs 91.2%, P=0.61) or reinterventions (3.0 vs 2.9%, p=0.99) between EUS-BD and ERCP cohorts, respectively. The endoscopic interventions did not impede subsequent pancreaticoduodenectomy that was performed in 5 of 33 (15.2%) patients in the EUS-BD and 5 of 34 patients (14.7%) in the ERCP group (p= 0.99). Conclusions Given the similar rates of adverse events and treatment outcomes in this randomized trial, EUS-BD is a practical alternative to ERCP for primary biliary decompression in pancreatic cancer. ClinicalTrials.gov identifier: NCT03054987.
Efficacy of anterior versus posterior per-oral endoscopic myotomy for treating achalasia: a randomized, prospective study Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-03-20 Yuyong Tan, Liang Lv, Xuehong Wang, Hongyi Zhu, Yi Chu, Min Luo, Chenjie Li, Hejun Zhou, Jirong Huo, Deliang Liu
Background and Aims Per-oral endoscopic myotomy (POEM) has been demonstrated to be safe and effective for treating achalasia. Two approaches―anterior myotomy and posterior myotomy―are used during POEM. However, little is known about the comparison between the two different approaches. The objective of the study is to compare the safety and short-term efficacy of the 2 approaches for treating achalasia. Methods From October 2015 to December 2016, 63 consecutive patients with achalasia without prior treatment or sigmoid-type esophagus were prospectively recruited. They were randomly assigned to an anterior or posterior myotomy group. Clinical data about general characteristics, operative parameters, pre- and postoperative Eckardt score, esophageal manometry results, 24-hour pH test, and adverse events were recorded and compared between the 2 groups. Results The anterior group included 31 patients, and the posterior group included 32 patients. All patients underwent POEM successfully, and treatment success (defined as an Eckardt score ≤3) was achieved in all patients during a mean follow-up of 15.5 months. Mean Eckardt score, lower esophageal sphincter pressure and 4-s integrated relaxation pressure were significantly decreased (6.2 ± 1.3, 37.5 ± 6.7 mm Hg and 27.3 ± 4.9 mm Hg vs 0.70 ± 0.70, 12.8 ± 2.8 mm Hg and 11.1 ± 2.3 mm Hg, respectively, p<0.01). There was no significant difference between the two groups in terms of general characteristics, treatment success, pre- and postoperative esophageal manometry, Eckardt score, and adverse events (P>0.05). Conclusions The short-term treatment efficacy, manometry outcomes and adverse events were comparable between the anterior and posterior myotomy groups. Large-scale studies with long-term follow-up are warranted for a more definitive conclusion.
A pilot single-center prospective randomized trial to assess the short-term effect of a flashing warning light on reducing fluoroscopy time and radiation exposure during ERCP Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-03-17 Hong-Ze Zeng, Qin Liu, Hong-Lin Chen, Wei Liu, Qi-Shan Zeng, Chun-Cheng Wu, Bing Hu
Background and Aims ERCP has the risk of exposure to ionizing radiation. Performers may unconsciously increase fluoroscopy time (FT) due to lack of radiation protection awareness. This study investigates whether a flashing warning light adopted as a behavioral intervention for performers reduces FT and radiation exposure during ERCP. Methods We conducted a prospective randomized trial of 200 therapeutic ERCPs. A flashing warning light was placed on top of the endoscopy monitor. Cases were consecutively enrolled and randomly assigned to two groups in a 1:1 ratio. In the warning light group, the light was on when the fluoroscopy foot pedal was being depressed; in the control group, the light was off. Fluoroscopy and procedure-related data were recorded. Results The median FT and dose-area product (DAP) for the warning light group versus the control group were 142.5 seconds versus 175.0 seconds (P = 0.045) and 856.8 μGy∙m2 versus 1054.4 μGy∙m2 (P = 0.043). In a multivariable analysis, the use of the warning light was found to reduce FT by 15.4% (-27.0 seconds; P = 0.042). DAP reduction due to the decrease of FT was 15.2% (160.3 μGy∙m2). The reduction in patient effective dose per case was 0.42 mSv, equivalent to 21 chest radiographs. No adverse events or interference with the procedures due to the warning light were noted. Conclusions The use of a flashing warning light is a feasible way to reduce FT and radiation exposure during ERCP.
The Paddington International virtual ChromoendoScopy ScOre (PICaSSO) in ulcerative colitis exhibits very good inter-rater agreement after computerized module training: a multicenter study across academic and community practice (with video) Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-03-13 Palak J. Trivedi, Ralf Kiesslich, James Hodson, Neeraj Bhala, Ralph A. Boulton, Rachel Cooney, Xianyong Gui, Tariq Iqbal, Ka-kit Li, Saqib Mumtaz, Shri Pathmakanthan, Mohammed Nabil Quraishi, Vandana M. Sagar, Ashit Shah, Naveen Sharma, Keith Siau, Samuel Smith, Stephen Ward, Monika M. Widlak, Raf Bisschops, Subrata Ghosh, Marietta Iacucci.
Introduction Electronic virtual chromoendoscopy (EVC) can demonstrate ongoing disease activity in ulcerative colitis (UC), even when Mayo subscores suggest healing. However, applicability of EVC technology outside the expert setting has yet to be determined. Methods 15 participants across 5 centers reviewed a computerized training module outlining high-definition (HD) and EVC (i-Scan) colonoscopy modes. Interobserver agreement was then tested (Mayo score, UCEIS and the Paddington International virtual ChromoendoScopy ScOre [PICaSSO] for UC), using a colonoscopy video library (n=30 cases reviewed pre- and n=30 post-training). Knowledge sustainability was re-tested in a second round (n=42 cases; 9/15 participants), 6 months after training provision. Results Pre-training intraclass correlation coefficients (ICC) were good for the Mayo endoscopic subscore (ICC:0.775), UCEIS scoring erosions/ulcers (ICC:0.770) and UCEIS overall (ICC:0.786), and for mucosal (ICC:0.754) and vascular components of PICaSSO (ICC:0.622). For the vascular components of UCEIS, agreement was only moderate (ICC:0.429), and did not enhance post-training (ICC:0.417); unlike for PICaSSO, which improved (mucosal ICC:0.848; vascular: 0.746). Histological correlation using the New York Mt. Sinai System was strong for both PICaSSO components (Spearman’s rho for mucosal: 0.925, and vascular: 0.873; p<0.001 for both). Moreover, accuracy in specifically discriminating quiescent from mild histological strata was strongest for PICaSSO (AUROC for mucosal: 0.781; vascular: 0.715), compared with Mayo (AUROC:0.708) and UCEIS (AUROC for UCEIS overall: 0.705; vascular: 0.562; bleeding: 0.645; erosions/ulcers: 0.696). Inter-rater reliability for PICaSSO was sustained by round 2 participants (Round 1 and 2 ICC for mucosal: 0.873 and 0.869, respectively; and vascular: 0.715 and 0.783, respectively), together with histological correlation (rho mucosal: 0.934, vascular: 0.938; p<0.001 for both). Conclusion PICaSSO demonstrates good interobserver agreement across all levels of experience, providing excellent correlation with histology. Given ability to discriminate subtle endoscopic features, PICaSSO may be applied to refine stratified treatment paradigms for UC patients.
High-definition colonoscopy versus Endocuff versus EndoRings versus Full-Spectrum Endoscopy for adenoma detection at colonoscopy: a multicenter randomized trial Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-03-09 Douglas K. Rex, Alessandro Repici, Seth A. Gross, Cesare Hassan, Prasanna L. Ponugoti, Jonathan R. Garcia, Heather M. Broadley, Jack C. Thygesen, Andrew W. Sullivan, William W. Tippins, Samuel A. Main, George J. Eckert, Krishna C. Vemulapalli
Background Devices used to improve polyp detection during colonoscopy have seldom been compared with each other. Methods We performed a 3-center prospective randomized trial comparing high-definition (HD) forward-viewing colonoscopy alone to HD with Endocuff to HD with EndoRings to the Full Spectrum Endoscopy (FUSE) system. Patients were age ≥50 years and had routine indications and intact colons. The study colonoscopists were all proven high-level detectors. The primary endpoint was adenomas per colonoscopy (APC) Results Among 1,188 patients who completed the study, APC with Endocuff (APC Mean ± SD 1.82 ± 2.58), EndoRings (1.55 ± 2.42), and standard HD colonoscopy (1.53 ± 2.33) were all higher than FUSE (1.30 ± 1.96,) (p<0.001 for APC). Endocuff was higher than standard HD colonoscopy for APC (p=0.014) . Mean cecal insertion times with FUSE (468 ± 311 seconds) and EndoRings (403 ± 263 seconds) were both longer than with Endocuff (354 ± 216 seconds) (p=0.006 and 0.018, respectively). Conclusions For high-level detectors at colonoscopy, forward-viewing HD instruments dominate the FUSE system, indicating that for these examiners image resolution trumps angle of view. Further, Endocuff is a dominant strategy over EndoRings and no mucosal exposure device on a forward-viewing HD colonoscope.
Endoscopic fistulotomy in inflammatory bowel disease (with video) Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-03-06 Gursimran Kochhar, Bo Shen
Background and Aims Fistulas in patients with inflammatory bowel disease (IBD) poses a key challenge in the management of the IBD patients. We aimed to describe a novel endoscopic method to treat the IBD patients who have fistulas. Methods A cohort of 29 consecutive patients with a fistula and IBD were identified in the registry of our interventional IBD unit. The endoscopic fistulotomy with needle-knife was performed. The primary outcome was healing of the fistula without the need for surgical intervention. Results A total of 29 patients underwent endoscopic fistulotomy; the mean age of patients undergoing the procedure was 44.2 ± 14.6 years. Thirteen patients were male (44.8%),16 were female (55.2%). Twenty-six patients (89.6%) achieved complete resolution of the fistula as confirmed by endoscopy with a guidewire and/or cross-sectional abdominal imaging, with 10 patients (34.4%) requiring a single endoscopic treatment session. Three patients (10.3%) had a persistent fistula and required surgical intervention. One patient had postoperative bleeding requiring blood transfusion and hospitalization. Conclusions Endoscopic fistulotomy with a needle-knife appears to be safe and effective in treating IBD-related fistulas.
Individualized colorectal cancer screening based on the clinical risk factors: beyond family history of colorectal cancer Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-03-03 Chan Hyuk Park, Nam Hee Kim, Jung Ho Park, Dong Il Park, Chong Il Sohn, Yoon Suk Jung
Background and Aims Individuals without a family history of colorectal cancer (CRC) are screened uniformly despite interpersonal risk. To assess individual risk, we examined the age-specific prevalence of advanced colorectal neoplasia (ACRN) according to clinical risk factors and fecal immunochemical test (FIT) results. Methods Participants without a family history of CRC who underwent screening colonoscopy and FIT were included. Clinical risk factors for ACRN were identified using a logistic regression model. Point scores were assigned to each associated factor based on a regression coefficient. Results A total of 34,658 participants were included. Age, male sex, smoking, and obesity were identified as risk factors. One, 2, and 1-point scores were assigned to male sex, smoking, and obesity, respectively. The prevalence of ACRN in individuals with 0, 1, and ≥2 risk score points was 1.4%, 1.6%, and 2.9% among those 50 to 51 years old and 3.1%, 5.5%, and 7.5% among those ≥66 years old, respectively. Among FIT-positive individuals, the prevalence of ACRN was 11.0% and 21.2% in those between 50 and 51 years and those ≥66 years, respectively. Among FIT-negative individuals with ≥2 risk score points, the prevalence of ACRN was 2.5% and 6.0% among those 50 to 51 and ≥66 years old, respectively. Conclusions If the clinical risk score is ≥2 points (persons with smoking history or obese men), early colonoscopy may be recommended, even with no family history of CRC. Additionally, FIT may be an appropriate initial screening modality for average-risk individuals if the clinical risk score is 0 to 1.
Visceral obesity as a risk factor for colorectal adenoma occurrence in surveillance colonoscopy Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-03-03 Jong Pil Im, Donghee Kim, Su Jin Chung, Eun Hyo Jin, Yoo Min Han, Min Jung Park, Ji Hyun Song, Sun Young Yang, Young Sun Kim, Jeong Yoon Yim, Seon Hee Lim, Joo Sung Kim
Background and Aims The aim of this study was to examine the prospective association between visceral obesity and the incidence and recurrence of colorectal adenoma. Methods We conducted a cohort study involving 2,244 participants between 2006 and 2007. The study participants were prospectively followed until 2014 according to the initial colonoscopic and histopathologic findings. Incident and recurrent colorectal adenoma groups were defined as individuals with a positive follow-up colonoscopy from among the normal and adenoma groups, respectively, at the baseline colonoscopy. Results Among the 1,163 subjects (51.8%) who received a follow-up colonoscopy, 509 subjects (43.8%) and 654 subjects (56.2%) were grouped into the normal and adenoma cohorts. Colorectal adenomas occurred in 592 subjects (50.9%) during median period of 43 months, with an incident adenoma prevalence of 39.1% and a recurrent adenoma prevalence of 60.1%. An increase in visceral adipose tissue (VAT) area was associated with a higher incidence of adenoma (highest quintile vs lowest quintile of the VAT hazard ratios [HRs], 2.16; 95% confidence interval [CI], 1.26-3.71; HR, 1.32 [per 1-SD]; 95% CI, 1.10-1.60) in the multivariable analysis. Increases in body mass index (BMI) and waist circumference (WC) were associated with recurrent adenoma (HR 1.33 [per 1 kg/m2], 95% CI, 1.18-1.46; HR, 1.04 [per 1 cm], 95% CI, 1.01-1.07, respectively) in the multivariate analysis. Conclusions A higher VAT area was dose-dependently associated with a higher risk of incident adenoma. Furthermore, increases in BMI and WC as surrogate marker of abdominal obesity, were associated with a higher risk of recurrent adenoma.
Impact of capsule endoscopy on prevention of postoperative recurrence of Crohn’s disease Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-03-03 Ze-min Han, Wei-guang Qiao, Xiu-yun Ai, Ai-min Li, Zhen-yu Chen, Xi-cheng Feng, Jie Zhang, Tian-mo Wan, Zhi-min Xu, Yang Bai, Ming-song Li, Si-de Liu, Fa-chao Zhi
Background and Aims Capsule endoscopy (CE) could detect lesions outside the scope of ileocolonoscopy in postoperative patients with Crohn’s disease (CD). However, the impact of such findings on patient outcomes remains unknown. This study is intended to evaluate the impact of CE findings on clinical management and outcomes in asymptomatic patients with CD without pharmacological prophylaxis after ileocolonic resection. Methods In this retrospective cohort study, 37 patients (group 1) received ileocolonoscopy together with CE within 1 year after surgery, whereas 46 patients (group 2) only received ileocolonoscopy. Patients with endoscopic recurrence detected by either ileocolonoscopy or CE received a pharmacological therapy with azathioprine or infliximab. One year later, disease activity was re-evaluated. Results In group 1, all patients with ileocolonoscopy-identified recurrence also had CE-identified recurrence. In addition, CE detected endoscopic recurrence in 11 patients missed by ileocolonoscopy. Endoscopic remission identified by ileocolonoscopy was confirmed by CE in 13 patients. One year later, endoscopic remission identified by ileocolonoscopy was maintained in all these 24 patients, and none of them had clinical recurrence. Conversely, in group 2, of those with ileocolonoscopy-identified remission, both ileocolonoscopy-identified recurrence and clinical recurrence occurred in 9 of 31 patients 1 year later. The total clinical recurrence rate was 2.7% (1/37) in group 1 versus 21.7% (10/46) in group 2 (P=0.019). Conclusions If endoscopic remission identified by ileocolonoscopy was confirmed by CE, patients could remain free of pharmacological prophylaxis. If recurrence outside the scope of ileocolonoscopy was detected by CE, initiation of active pharmacological therapy would be needed.
Feasibility and safety of micro-forceps biopsy in the diagnosis of pancreatic cysts Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-03-03 Omer Basar, Osman Yuksel, Dennis Yang, Jason Samarasena, David Forcione, Christopher J. DiMaio, Mihir S. Wagh, Kenneth Chang, Brenna Casey, Carlos Fernandez-del Castillo, Martha B. Pitman, William R. Brugge
Background and Aim The tissue acquisition and diagnostic yield of cyst fluid cytology is low-to-moderate and rarely provides a specific diagnosis. The aim of this study was to compare the tissue acquisition and diagnostic tissue yield of micro-forceps biopsy (MFB) with cyst fluid cytology. Patients and Methods The data of 42 patients, whose cysts were aspirated by EUS-guided fine needle aspiration (EUS-FNA) and then biopsied with MFB device in this multicenter study, were collected. Cytological analysis of cyst fluid and histological analysis of biopsy samples were processed. Acquisition yield was defined as percentage of patients with tissue present in the aspirate or biopsy. Diagnostic tissue yield was evaluated at 3 levels: the ability of differentiation between mucinous/non-mucinous cysts; detection of high-risk for malignancy; and specific cyst type diagnosis. Results The mean patient age was 69 years. Sixteen (38.1%) cysts were localized in head, 17 (40.5%) body, and 9 (21.4%) in tail. The mean cyst size was 28.2 mm (12-60 mm); 25 of 42 (60%) were septated. EUS-FNA tissue (fluid) acquisition yield was 88.1% (37/42). MFB tissue acquisition yield was 90.4% (38/42). The diagnostic cytology yield to differentiate between mucinous/non-mucinous cyst was 47.6% (20/42) and MFB histological yield o differentiate between mucinous/non-mucinous cyst was 61.9% (26/42) (p=0.188). The percentage of cysts at high-risk for malignancy by cytology was 54.7% (23/42) and MFB was 71.5% (30/42) (p=0.113). However, the ability of MFB to provide a specific cyst type diagnosis was 35.7% (15/42) and cytology was 4.8% (2/42) (p=0.001). Surgical histology was concordant with MFB in 6 of 7 (85%) patients and with cytology in 1 of 7 (15%) patients. Conclusion The cyst tissue acquisition yield for the MFB was 90%. Although cytology of cyst fluid and MFB were comparable in distinguishing mucinous and non-mucinous cysts and detecting cysts at high-risk for malignancy, the MFB was far superior to cytology for providing a specific cyst diagnosis.
Submucosal tunnel endoscopic resection for extraluminal tumors: a novel endoscopic method for en bloc resection of predominant extraluminal growing subepithelial tumors or extra-gastrointestinal tumors (with videos) Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-27 Ming-Yan Cai, Bo-Qun Zhu, Mei-Dong Xu, Wen-Zheng Qin, Yi-Qun Zhang, Wei-Feng Chen, Marie Ooi, Quan-Lin Li, Li-Qing Yao, Ping-Hong Zhou
Background and Aim The management of subepithelial tumors with a predominant extraluminal growth pattern or extra-gastrointestinal (GI) tumors can be challenging and traditionally requires a surgical resection that is not only invasive but may carry a significant risk of morbidity and mortality. We aim to assess the feasibility, safety and efficacy of a novel endoscopic technique termed as submucosal tunnel endoscopic resection for Extraluminal Tumors (STER-ET). Methods We prospectively enrolled patients who underwent STER-ET for gastrointestinal subepithelial tumors with a predominant extraluminal growth pattern or extra-GI tumors located at the level of cardia or the proximal part of the lesser curvature of the stomach seen on cross-sectional imaging between January 2016 and March 2017. Results Eight patients underwent STER-ET. The mean tumor size was 2.8 ± 0.6 cm and 2.3 ± 0.8 cm in longest and shortest dimension, respectively. The average procedure time was 67 ± 4.4 minutes. The rate of curative en bloc resection and rate of en bloc retrieval was 100% and 87.5%, respectively. On final histology, 6 tumors were GISTs, one was a schwannoma and one was a foregut cyst. Five patients had capnoperitoneum during procedure and required abdominal decompression. One patient had a small mucosotomy successfully treated with a hemostatic clip. There were no major adverse events or death. The median length of hospital stay was 3 days. There was no residual tumor on surveillance imaging after a mean follow-up period of 10.0 ± 2.1 months. Conclusion STER-ET is a novel technique that appears to be safe and effective in achieving a curative resection for gastrointestinal subepithelial tumors with a predominantly extraluminal growth pattern or extraluminal tumors in a selected group of patients. However, larger studies are required to validate our finding.
Adherence to colorectal cancer screening measured as the proportion of time covered Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-23 Caitlin C. Murphy, Bianca M. Sigel, Edward Yang, Celette Sugg Skinner, Ethan A. Halm, Samir Gupta, Joanne M. Sanders, Katharine McCallister, Amit G. Singal
Background and Aims Colorectal cancer (CRC) screening can reduce CRC incidence and mortality, but measuring screening adherence over time is challenging. We examined adherence using a novel measure characterizing the proportion of time covered (PTC) by screening tests. Methods Eligible patients were age 50 to 60 years and followed at a large, safety-net healthcare system between January 2010 and September 2014. We estimated PTC as the number of days up-to-date with screening divided by number of days from cohort entry until study end, CRC diagnosis, or death. We estimated mean and median PTC and used least significant difference tests to assess differences in adherence by patient characteristics. Results Of 18,257 patients, most were non-Hispanic black (40.5%) or Hispanic (34.9%) and female (62.4%). Approximately 40% (n=7,559) were never screened during the study period; the remaining 10,698 patients completed 19,105 screening examinations (14,481 FITs, 4,393 colonoscopies, 94 sigmoidoscopies, and 137 barium enemas). Overall, mean PTC was 29.1% (95% CI, 28.6% - 29.5%). Among those who completed at least one screening test (n=10,698), mean PTC was 49.0% (95% CI, 48.5% - 49.5%). Most common reasons for non-adherence were lack of repeat FIT and no diagnostic colonoscopy after abnormal FIT. Mean PTC increased with number of primary care visits (0 visits: 21%, 1 visit: 29%, 2-3 visits: 35%, ≥4 visits: 37%, all p<0.05). Conclusions PTC provides a reliable estimate of screening adherence, capturing breakdowns in the CRC screening process amenable to intervention. Repeat FIT and diagnostic colonoscopy are important intervention targets that may increase adherence in underserved populations.
Identification of volumetric laser endomicroscopy features of colon polyps with histologic correlation Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-23 Arvind J. Trindade, Arvind Rishi, Robert Hirten, Sumant Inamdar, Divyesh V. Sejpal, Jean-Frederic Colombel
Background and Aims There is limited data on the use of volumetric laser endomicroscopy (VLE) in imaging for colon polyps. Our aim was to identify VLE features of colon polyps. Methods A total of 45 patients were included. 43 underwent endoscopic mucosal resection of colorectal polyps 2 cm or greater. These polyps were then scanned with VLE immediately after resection. Two patients that underwent partial colonic resection served as controls. Results Forty-three polyps were included with review of matching histology: 3 intramucosal adenocarcinoma (IMCA), 5 tubular adenoma (TA)/tubulovillous adenoma (TVA) with high-grade dysplasia (HGD), 9 TVA with only low-grade dysplasia (LGD), 5 serrated adenoma (SA), and 21 TA with LGD. All TA and TVA were hyper-reflective compared with normal tissue. Effacement occurred in 82.4% (14/17) of the colonic polyps with advanced pathology (TVA with HGD/IMCA) compared with 11.6% (3/26) of non-advanced pathology (TA with LGD and SA) (P<0.0001). Forty-seven percent (8/17) of advanced pathology had greater than 5 glands on VLE as compared with none in the non-advanced pathology group (P=0.0001). An irregular surface mainly occurred in polyps with high-grade pathology (HGD/IMCA) versus tubular adenomas. Eight-eight percent of polyps with HGD/IMC had an irregular surface (7/8) versus 6% (2/35) of TA (P<0.0001). Conclusions In this ex-vivo clinicopathological study, we show that there are distinct VLE features of colon polyps that may help identify polyps or features of a higher-grade lesion. This may have implications for possible in-vivo application to aid in dysplasia or polyp detection.
Secondary tumors of the gastrointestinal tract: origin, histology, and endoscopic findings Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-22 Magdalena M. Gilg, Hans-Peter Gröchenig, Andrea Schlemmer, Andreas Eherer, Christoph Högenauer, Cord Langner
Background and Aims The gastrointestinal tract (GIT) is rarely affected by secondary tumors. Patients often present at advanced stage, and prognosis is dismal. This study aimed to analyze clinical, endoscopic and pathological features of secondary tumors that had been diagnosed endoscopically. Methods We conducted a retrospective database analysis of 217 patients with secondary tumors of the GIT. Endoscopic findings and histological diagnoses were systematically re-evaluated. Results Malignant melanoma (n= 33, 15%), breast (n= 32, 15%) and pancreatic cancer (n=27, 12%) were the most common corresponding primaries. About one-third of secondary tumors was detected in the stomach (n=76, 35%), followed by small intestine (n=54, 25%) and rectum (n=53, 24%). Median time between diagnosis of primary and secondary tumors was 19 months (mean, 31, range 0-251) and this was particularly long for renal cell carcinoma and breast cancer (median 38 and 45 months, respectively). Direct invasion from extragastrointestinal malignancies was more common (56%) than vascular cancer spread (44%) and depended on both site of tumor involvement and corresponding primary. Lesions presented with various endoscopic patterns. In patients for whom a definitive diagnosis of cancer was known before the examination (n=168), a secondary tumor was included in differential diagnosis in only 48% of lesions. It is of note that the remaining cases were diagnosed endoscopically as primary tumor and rarely also as non-neoplastic change. Conclusions Secondary tumors may affect all parts of the GIT. Malignant melanoma and breast and pancreatic cancer represent the most common primaries. Biopsy diagnosis is crucial to avoid misclassification.
Gastric mucosal devitalization is safe and effective in reducing body weight and visceral adiposity in a porcine model Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-22 Vivek Kumbhari, Stefanie Lehmann, Nadine Schlichting, Marco Heinrich, Yvonne Kullnick, Ulf Retschlag, Markus Enderle, Arne Dietrich, Mouen A. Khashab, Anthony N. Kalloo, Andreas Oberbach
Background and Aims The early improvement in metabolic profile after sleeve gastrectomy (SG) indicates that the significant benefits of metabolic surgery are gastric in origin. We have previously demonstrated that devitalization of the gastric mucosa (without a reduction in gastric volume) in metabolically disturbed obese rats results in an improvement of obesity and its associated comorbidities. The aims of this study were to assess the technical feasibility, efficacy and safety of gastric mucosal devitalization (GMD) in a large animal (porcine) model. Methods A 3-arm (GMD versus SG versus sham (SH)) prospective randomized controlled trial with an 8-week follow-up period. Primary endpoint was relative weight loss. Secondary endpoints were included absolute body weight, abdominal visceral adiposity, abdominal subcutaneous adiposity, organ lipid content and serum ghrelin. Results GMD resulted in a significant relative weight loss of 36% over SH at 8 weeks (p<0.05). There was no significant difference in relative weight loss between GMD versus SG at 4 weeks; however, SG resulted in a 29% superior relative weight loss at 8 weeks (p<0.05). With regard to visceral adiposity, there was a significant benefit of GMD over SH at 8 weeks. Despite differences in relative weight loss, there was no significant difference in visceral adiposity between SG versus GMD at 8 weeks. Significant improvements in GMD over SH were noted with regards to skeletal and heart muscle lipid content. GMD pigs at 8 weeks demonstrated regeneration of the gastric mucosa without ulceration or significant scarring. Despite mucosal regeneration, the abundance of serum ghrelin was significantly lower in the GMD cohort compared with the SG and SH cohorts. Conclusions GMD was technically feasible and resulted in relative weight loss and an improvement in visceral adiposity. The benefits noted were out of proportion to what would be expected with weight loss alone.
Cryotherapy for persistent Barrett’s esophagus after radiofrequency ablation: a systematic review and meta-analysis Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-22 Kavel Visrodia, Liam Zakko, Siddharth Singh, Cadman L. Leggett, Prasad G. Iyer, Kenneth K. Wang
Background and Aims A small but significant proportion of patients with Barrett’s esophagus (BE) have persistent dysplasia or intestinal metaplasia (IM) after treatment with radiofrequency ablation (RFA). Cryotherapy is a cold-based ablative modality that is increasingly being used in this setting. We aimed to better understand the efficacy of second-line cryotherapy in BE patients with persistent dysplasia or IM after RFA by conducting a systematic review and meta-analysis. Methods We performed a systematic literature search of PUBMED, EMBASE, and Web of Sciences through September 1, 2017. Articles were included for meta-analysis based on the following inclusion criteria: ≥5 BE patients treated with RFA had persistent dysplasia or IM; they subsequently underwent ≥1 session of cryotherapy with follow-up endoscopy; the proportions of patients achieving complete eradication of dysplasia (CE-D) and/or IM (CE-IM) were reported. The main outcomes were pooled proportions of CE-D and CE-IM using a random effects model. Results Eleven studies comprising 148 BE patients treated with cryotherapy for persistent dysplasia or IM after RFA were included. The pooled proportion of CE-D was 76.0% (95% CI, 57.7-88.0) with substantial heterogeneity (I2=62%). The pooled proportion of CE-IM was 45.9% (95% CI, 32.0-60.5) with moderate heterogeneity (I2=57%). Multiple pre-planned subgroup analyses did not sufficiently explain the heterogeneity. Adverse effects were reported in 6.7% of patients. Conclusions Cryotherapy successfully achieves CE-D in three-quarters and CE-IM in half of BE patients who do not respond to initial RFA. Considering its favorable safety profile, cryotherapy may be a viable second-line option for this therapeutically challenging cohort of BE patients, but higher-quality studies validating this remain warranted.
A randomized trial of single versus double high-level disinfection of duodenoscopes and linear echoendoscopes using standard automated reprocessing Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-21 Rebecca L. Bartles, James E. Leggett, Shannan Hove, Catherine D. Kashork, Lian Wang, Margret Oethinger, Lynda Baxter, Jack J. Brandabur
Background and Aims In a pilot study (8) we demonstrated that current guidelines for duodenoscope and linear echoendoscope (DLE) reprocessing using a single cycle of high-level disinfection (HLD) in an automated reprocessor may be inadequate. In August 2015, the FDA offered double-HLD as a possible response to address this concern. As a result, Providence Health & Services adopted double-HLD as standard procedure for DLE, but no rigorous clinical studies supported this practice. We undertook a quality improvement (QI) study to compare single-HLD versus double-HLD at 4 of our 34 hospitals. Methods HLD of DLE was randomized, separately in each facility, to either single-HLD or double-HLD on weekdays, with standard double-HLD on weekends or holidays. There was 99.7% compliance with the randomization scheme. Daily qualitative surveillance cultures of dried, post-HLD DLE were collected for 6 months (1 swab sample from elevator mechanism and 1 combined brush sample from suction and working channels for each encounter), and each sample was incubated for 48 hours. Positivity rates of any microbial growth and growth of high-concern pathogens (potentially pathogenic enteric flora) were compared between the two study arms. Results Altogether, 5850 surveillance culture specimens were obtained during 2925 encounters from the 45 DLEs in clinical use in the participating hospitals. Of these, 3052 (52.2%) were from endoscopes cleaned by double HLD. Double-HLD demonstrated no benefit over single-HLD as similar positivity rates were observed (all p-values > 0.05). The elevator mechanism was more frequently colonized than the biopsy channel (5.2% vs 2.9%, p<0.001). Among the 224 encounters with positive growth, 140 (62.5%) recovered microbes from only the elevator mechanism specimens, 73 (32.6%) recovered microbes from only the channel specimens, and 11 (4.9%) recovered microbes from both types of specimens. Double-HLD failed to improve contamination rates for either sample site at any of the 4 endoscopy facilities, although there were significant overall differences in contamination rates among the facilities (p<0.001), as observed in our previous study. Only 8 high-concern pathogens were recovered from 5 DLE scopes, all from the elevator mechanism. Persistent growth was observed on two duodenoscopes. One grew Enterococcus spp (not vancomycin-resistant enterococci) on 3 occasions, Eschericia coli was present on 2 of these occasions, one of which was a multi-drug resistant organism (MDRO). The other grew different enteric flora on 2 specimens. Conclusions Our prospectively randomized study, involving 4 separate endoscopy facilities and standard automated endoscope reprocessing, showed that double-HLD did not reduce culture positivity rates compared with single-HLD in facilities with an already low positive culture rate. Alternative risk mitigation strategies will be assessed in an ongoing effort to reduce endoscope contamination.
Optimizing duodenoscope reprocessing: rigorous assessment of a culture and quarantine protocol Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-21 Jennifer T. Higa, Jaehoon Choe, Deborah Tombs, Michael Gluck, Andrew S. Ross
Background/Aims Iatrogenic infections related to duodenoscopes remain a top concern for medical centers where ERCP is performed. We assess the long-term results and the impact of key interventions in the optimization of a rigorous “culture and quarantine” program for duodenoscope reprocessing. Methods Review of a prospectively collected, quality assurance database of all duodenoscope cultures (N = 4307) obtained for the initial 3-year duration of culture and quarantine from 2014 to 2017 in a single U.S.-based, high volume endoscopy center. All duodenoscopes were subject to manual cleaning and automated reprocessing and drying, followed by sampling using a modified protocol developed by the Centers for Disease Control and Prevention. Duodenoscopes were cultured per-use. Results A total of 4,307 duodenoscope cultures were obtained during the study period. High-concern organisms were isolated from 33 of these cultures, resulting in a 0.697 % HLD defect rate. Statistically significant interventions included withdrawal of a high-frequency culture-positive duodenoscope (scope A) from clinical service in addition to implementation of new manufacturer-recommended cleaning protocols. Withdrawal of a second high-frequency culture-positive duodenoscope (scope B) and a mandatory device retrofit had no effect on the observed rate of positive duodenoscope cultures. Conclusions Withdrawal of duodenoscopes with high rate of culture positivity, and optimizing manual cleaning practices have contributed to an overall decline in the high level disinfection defect rate. A stringent culture and quarantine protocol allowed identification of the culprit endoscopes. There remains a much-needed role for an inexpensive and highly reliable method to check on the adequacy of reprocessing given the inherent complexity of these tasks.
Impact of cleaning monitoring combined with channel purge storage on elimination of Escherichia coli and environmental bacteria from duodenoscopes Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-21 Harminder Singh, Donald R. Duerksen, Gale Schultz, Carol Reidy, Pat DeGagne, Nancy Olson, Zoann Nugent, Kathryn A. Bernard, Michelle J. Alfa
Background and Aims We aimed to at determine whether monitoring of duodenoscope cleaning by rapid adenosine-tri-phosphate (ATP) combined with channel-purge storage could eliminate high-concern microorganisms. Methods In a simulated-use study, suction channels from two duodenoscopes models and the unsealed elevator guidewire (EGW) channel from one of these two duodenoscopes (the other model has a sealed EGW) were perfused with ATS2015 containing approximately 8 Log10 CFU/mL of both Enterococcus faecalis and Escherichia coli. Pump-assisted cleaning was monitored using rapid ATP testing. Duodenoscopes exceeding 200 relative light units (RLUs) were re-cleaned. Clean duodenoscopes were processed through an Automated Endoscope Reprocessor and then stored in a channel-purge storage cabinet for 1 to 3 days. Cultures of EGW channel and instrument channel combined with the lever recess (IC-LR) were taken after storage. The impact of extended cleaning and alcohol flush were evaluated. Results E coli was reliably eliminated in IC-LR and EGW channels of 119 duodenoscope tests (59 with sealed EGW and 60 with non-sealed EGW). However, actionable levels of E faecalis and environmental bacteria persisted. Neither alcohol flush nor extended cleaning resulted in a reduction of actionable levels for these organisms. Identification of isolates indicated that residual organisms in duodenoscope channels were hardy Gram positive bacteria (often spore formers) that likely originated from environmental sources. Conclusions These data indicate that high-concern gram negatives but not E faecalis or environmental bacteria can be reliably eliminated following manufacturer’s instructions for reprocessing with ATP monitoring of cleaning and channel-purge storage conditions.
The phenotypic heterogeneity of hereditary diffuse gastric cancer: the report of one family with early-onset disease Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-15 Irene Gullo, Vitor Devezas, Manuela Baptista, Luzia Garrido, Sérgio Castedo, Rui Morais, Xiaogang Wen, Elisabete Rios, Jorge Pinheiro, Inȇs Pinto-Ribeiro, Rui M. Ferreira, John Preto, João Santos-Antunes, Margarida Marques, Miquel Campos, Filipe Almeida, Maria do Céu Espinheira, Jorge Amil Dias, Céu Figueiredo, Carla Oliveira, Eunice Trindade, Fátima Carneiro
Background and Aims The time-course for the development of clinically significant hereditary diffuse gastric cancer (HDGC) is unpredictable. Little is known about the progression from pre-clinical, indolent lesions to widely invasive, aggressive phenotypes. Gastro-endoscopy often fails to detect early lesions and risk-reducing/prophylactic total gastrectomy (PTG) is the only curative approach. We present a HDGC family with early-onset disease, in which clinical and histological findings provided insight into the understanding of different HDGC phenotypes. Methods and Results The proband was diagnosed at the age of 18 years with widely invasive, metastatic DGC. CDH1 genetic testing identified a pathogenic, germline CDH1-mutation (c.1901C>T, p.Ala634Val). Thirty family members were tested and 15 CDH1 carriers were identified. Six of them had PTG, with negative preoperative work-up. The proband’s 14-year-old sister is the youngest patient, reported to date, to have PTG after negative preoperative biopsies. Intramucosal HDGC foci were detected in all PTG specimens (n=1-33). In contrast to the “indolent” phenotype of these foci, the aggressive DGC from the proband showed pleomorphic cells, absent E-cadherin expression, increased proliferation (Ki-67 index) and activation of oncogenic events (p53, pSrc and pStat3 overexpression). All family members had Helicobacter pylori gastritis. Cag-A-positive strains were detected in all specimens, except in the proband’s sister. Conclusions HDGC is a heterogeneous disease regarding clinical behavior, endoscopic findings, histopathologic features, and immunophenotypic/molecular profile. The presence of bizarre, pleomorphic cells in endoscopic biopsy specimens is suggestive of advanced disease and should prompt clinical intervention. The involvement of a full multidisciplinary team is essential for the management of these patients.
Clinical outcomes and factors related with colonic perforations in patients receiving self-expandable metal stent insertion for malignant colorectal obstruction Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-13 Yoo Jin Lee, Jin Young Yoon, Jae Jun Park, Soo Jung Park, Jie-Hyun Kim, Young Hoon Youn, Tae Il Kim, Hyojin Park, Won Ho Kim, Jae Hee Cheon
Background and aims Although colonic perforation is a dreadful adverse event associated with stent placement, data on this topic are sparse. We aimed to investigate the clinical outcomes of colonic perforation and factors related with its occurrence in patients who receiving self-expanding metal stents (SEMSs) for malignant colorectal obstruction. Methods We retrospectively reviewed the data of 474 patients with malignant colorectal obstruction who received endoscopic SEMS insertion from April 2004 to May 2011 in the Severance and Gangnam Severance Hospital. Early perforation, defined as perforation occurring within 2 weeks, was assessed in bridge-to-surgery (n=164) and palliative stent placement patient groups (n=310). Delayed perforation was analyzed using data from the palliative stent placement group alone. Results The technical and clinical success rates were 90.5% and 81.0%, respectively. Early and delayed perforations occurred in 2.7% (13/474) and 2.7% (8/301) of the patients, respectively. Among 21 patients with perforation, 14 (66.7%) received emergency surgery and 5 (23.8%) died within 30 days after perforation. Regarding the perforation-related factors, age of ≥70 years (odd ratio [OR], 3.276; 95% confidence interval [CI], 1.041–10.309) and sigmoid colonic location (OR, 7.706; 95% CI, 1.681–35.317) were independently associated with occurrence of early perforation. Stent location in the flexure (hazard ratio [HR], 17.573; 95% CI, 2.004–154.093) and absence of peritoneal carcinomatosis (HR, 6.139; 95% CI, 1.150–32.776) were significantly associated with delayed perforation. Conclusions The perforation-related 30-day mortality rate was 23.8%. Older age and sigmoid colonic location were significantly associated with occurrence of early perforation, whereas flexure location and absence of peritoneal carcinomatosis were related with delayed perforation.
Feasibility of EUS-guided Nd:YAG laser ablation of unresectable pancreatic adenocarcinoma Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-13 Francesco Maria Di Matteo, Paola. Saccomandi, Margareth Martino, Monica Pandolfi, Margherita Pizzicannella, Valerio Balassone, Emiliano Schena, Claudio Marcello Pacella, Sergio Silvestri, Guido Costamagna
Background and aims Endoscopic ultrasound (EUS) has become an interventional technique in which a needle may be used as a vehicle to deliver therapeutic agents. Laser ablation (LA) has been used to treat many primary and secondary neoplasms. This study aimed to assess the feasibility of EUS-guided LA for unresectable (UR) pancreatic cancer. Methods Patients with a stage IIb-III pancreatic cancer underwent EUS-guided LA. All patients were unresponsive to previous chemo-radiotherapy. The laser ablation was performed by using a 300-μm flexible fiber preloaded on a 22-gauge fine needle. A 1064-nm wavelength Nd:YAG laser light with different power settings of 2 W for 800 J, 1000 J and 1200 J, 3 W for 800 J, 1000 J and 1200 J and 4 W for 800 J, 1000 J and 1200 J was used. Each patient was treated with a single application of one of these settings. The application time of the power settings ranged from 200s to600s. Results Nine patients (median age 74.7, range 55-85 years) underwent Nd:Yag LA. The mean size of the focal lesion was 35.4 mm (range 21-45 mm). The ablation area demonstrated by 24 hours computed tomography (CT)-scan, ranged from 0.4 cm3 (for the lower power setting of 2 W/800 J) to a maximum of 6.4 cm3 (for 4 W/1000 J). The procedure was completed in all 9 patients without adverse events. Conclusion In our human experience EUS-guided LA was feasible and well tolerated in patients with UR pancreatic cancer.
Scoping the scope: endoscopic evaluation of endoscope working channels with a new high-resolution inspection endoscope (with video) Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-06 Monique T. Barakat, Mohit Girotra, Robert J. Huang, Subhas Banerjee
Background Outbreaks of transmission of infection related to endoscopy despite reported adherence to reprocessing guidelines, warrant scrutiny of all potential contributing factors. Recent reports from ambulatory surgery centers indicated widespread significant occult damage within endoscope working channels, raising concerns regarding the potential detrimental impact of this damage on the adequacy of endoscope reprocessing. Methods We inspected working channels of all 68 endoscopes at our academic institution using a novel flexible inspection endoscope. Inspections were recorded and videos reviewed by three investigators to evaluate and rate channel damage/debris. Working channel rinsates were obtained from all endoscopes and ATP bioluminescence measured. Results Overall endoscope working channel damage was rated as minimal/mild and consistent with expected “wear and tear” (median 1.59 on our 5-point scale), with predominant findings including superficial scratches (98.5%), and scratches with adherent peel (76.5%). No channel perforations, stains or burns were detected. Extent of damage was not predicted by endoscope age. Minor punctate debris was common and a few small drops of fluid were noted in 42.6% endoscopes after reprocessing and drying. The presence of residual fluid predicted higher ATP bioluminescence values. Presence of visualized working channel damage or debris was not associated with elevated ATP bioluminescence values. Conclusions The flexible inspection endoscope enables high-resolution imaging of endoscope working channels and offers endoscopy units an additional modality for endoscope surveillance, potentially complementing bacterial cultures and ATP. Our study, conducted in a busy academic endoscopy unit, indicated predominately mild damage to endoscope working channels, which did not correlate with elevated ATP values.
ERCP performed through previously placed duodenal stents: a multicenter retrospective study of outcomes and adverse events Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-06 Judith Staub, Ali Siddiqui, Linda Jo Taylor, David Loren, Tom Kowalski, Douglas G. Adler
Background and Aims ERCP (endoscopic retrograde cholangiopancreatography) performed through previously placed enteral stents is an uncommon procedure without a significant amount of supporting literature, and with a wide reported range of technical success. The purpose of this study was to evaluate and better define the technical feasibility and safety of performing ERCP through enteral stents in patients with combined malignant biliary and gastric outlet obstruction (GOO). Methods We conducted a multicenter, retrospective study on 71 patients with combined gastric outlet and biliary obstruction who underwent ERCP through a previously placed enteral stent at 2 tertiary care centers. Outcomes included, but were not limited to, technical success, clinical success, need for repeat ERCP, adverse events, and survival time. Results Overall technical success was achieved in 60 of 71 patients (85%), with technical success of 40 of 46 (87%) in Type I obstructions (GOO above the ampulla), 16/21 (76%) in Type II obstructions (GOO at the level of the ampulla) and 4 of 4 (100%) in Type III obstructions (GOO distal to the ampulla). In general, patients who achieved technical success also achieved clinical success. Adverse events occurred in 3 patients (3/71), because 2 patients had acute cholangitis and 1 patient a perforation. Average survival time after the procedure was 4.6 months overall. Conclusions ERCP performed through enteral stents is safe with a high technical and clinical success rate, but may be more technically challenging in the setting of type II obstructions. This procedure could be considered first line in the unique setting that a patient requires ERCP through a previously placed enteral stent for malignant gastric outlet and biliary obstruction.
Impact of 2 generational improvements of colonoscopes on adenoma miss rates: results of a prospective randomized multicenter tandem study Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-01-31 Mathieu Pioche, Angelique Denis, Hans-Dieter Allescher, Gianluca Andrisani, Guido Costamagna, Evelien Dekker, Paul Fockens, Christian Gerges, Stefan Groth, Jennis Kandler, Isabelle Lienhart, Horst Neuhaus, Lucio Petruzziello, Guido Schachschal, Kristien Tytgat, Jürgen Wallner, Vincens Weingart, Sandrine Touzet, Thierry Ponchon, Thomas Rösch
Background and Aims Numerous randomized studies have shown that changing certain features of colonoscopes, usually incorporated when switching from one endoscope generation to the next, mostly do not increase adenoma yield. There is, however, indirect evidence that it may be necessary to skip one instrument generation (ie, changing from one generation to the next but one) to achieve this effect. Methods We compared the latest-generation colonoscopes from one company (Olympus Exera III, 190-C) with the next to last one (Olympus 160/5-C) in a prospective multicenter study randomized for the order of colonoscopes in a tandem fashion, involving 2 different examiners. Patients with increased risk for colorectal neoplasia undergoing colonoscopy (FOBT positive, personal/familial history of CRC/adenoma, rectal bleeding, recent change in bowel movements) were included. Primary outcome was the adenoma miss rate with 190 (190-C) in comparison to 160/5 colonoscopes (160/5-C). Results 856 patients (48.8%male, mean age 58.3 years) with personal (41%) or family (38%) history of colorectal neoplasia, rectal bleeding (19%) and other indications were included. Of the 429 patients in the 190-C first group, 16.6% (95% CI, 13.0 % - 20.1%) had at least one adenoma missed during the first procedure, as compared with 30.2% (95% CI, 25.9% - 34.6%) in the group with 160/5-C first (p<0.001). Similarly, adenoma detection rate during the first colonoscopy was 43.8% versus 36.5% (p=0.030) for 190-C versus 160/5160/5-C, respectively. Conclusions This randomized tandem trial showed lower adenoma miss rates and higher adenomas detection rates for the newer 190-colonoscopes compared with the 160/5-series. These results suggest that it takes multiple improvements such as those implemented over 2 instrument generations before an effect on adenoma (miss) rate can be observed.
Life after Per-oral Endoscopic Myotomy (POEM): Long-term Outcomes of Quality of Life and Their Association with Eckardt Score Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-02 Yaseen B. Perbtani, Lazarus K. Mramba, Dennis Yang, Jorge Suarez, Peter V. Draganov
Background and Aims The clinical efficacy of POEM has been commonly established by the reduction in the Eckardt score (<3) after the procedure. However, achalasia can lead to significant impairment in the patient’s quality of life that may go beyond the 4 classical achalasia symptoms as measured by the Eckardt score. The aims of our study were (1) to evaluate the effect of POEM on short and long-term health-related quality of life (HRQOL) and to (2) assess the association between HRQOL and Eckardt scores. Methods Single-center prospective cohort study of consecutive POEMs during a 3-year period. Eckardt and HRQOL scores as measured by the short-form survey questionnaire (SF-36) were obtained at baseline, and at various intervals post-POEM. Comparison of the mean scores were described using univariate linear regression. The association between Eckardt scores and HRQOL were performed by using a linear mixed model analysis. Results POEM was performed in 143 consecutive patients (54% male; mean age 56.9 ± 17.9 years). At long-term follow-up (mean 16.4 months, range: 12-40), both the HRQOL baseline mental and physical component scores improved significantly from 61.5 ± 2.2 to 71.2 ± 3.6 (p < 0.021), and from 55.8 ± 2.2 to 63.6 ± 3.3 (p = < 0.034), respectively. Mixed model analysis showed a significant association between Eckardt and all HRQOL scores (p<0.001). Conclusions POEM improved all dimensions of HRQOL as measured by the SF-36 survey at both short- and long-term follow-up. A strong association was seen between Eckardt score and all HRQOL domains. Further studies using disease specific HRQOL instruments are warranted.
Outcomes of endoscopic biliary drainage in pancreatic cancer patients with an indwelling gastroduodenal stent: a multicenter cohort study in west Japan Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-01-31 Kentaro Yamao, Masayuki Kitano, Mamoru Takenaka, Kosuke Minaga, Toshiharu Sakurai, Tomohiro Watanabe, Takahisa Kayahara, Tomoe Yoshikawa, Yukitaka Yamashita, Masanori Asada, Yoshihiro Okabe, Keiji Hanada, Yasutaka Chiba, Masatoshi Kudo
Background and Aims Gastroduodenal and biliary obstruction may occur synchronously or asynchronously in advanced pancreatic cancer, and endoscopic double stent placement may be required. EUS-guided biliary drainage (EUS-BD) is often performed after unsuccessful endoscopic transpapillary stent placement (ETS), and EUS-BD may be beneficial in double stent placement. This retrospective multicenter cohort study compared the outcomes of ETS and EUS-BD in patients with an indwelling gastroduodenal stent (GDS). Methods We recorded the clinical outcomes of patients at 5 tertiary medical centers who required biliary drainage after GDS placement between March 2009 and March 2014. Results Thirty-nine patients were included in this study. Patients’ mean age was 68.5 years; 23 (59.0%) were men. The GDS overlaid the papilla in 23 patients (59.0%). The overall technical success rate was significantly higher with EUS-BD (95.2%) than ETS (56.0%, P <0.01). Furthermore, the technical success rate was significantly higher with EUS-BD (93.3%) than ETS (22.2%, P <0.01) when the GDS overlaid the papilla. The overall clinical success rate of EUS-BD was also significantly higher than for ETS (90.5% versus 52.0%, respectively; P = 0.01) and there was no significant difference in the incidence of adverse events (ETS, 32.0% versus EUS-BD, 42.9%; P = 0.65). Conclusions Endoscopic double stent placement with EUS-BD is technically and clinically superior to ETS in patients with an indwelling GDS. EUS-BD should be considered the first-line treatment option in patients with an indwelling GDS that overlies the papilla. ETS remains a reasonable alternative when the papilla is not covered by the GDS.
rIncremental yield of dysplasia detection in Barrett’s esophagus using volumetric laser endomicroscopy with and without laser marking compared with a standardized random biopsy protocol Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-02 Mohammad Alshelleh, Sumant Inamdar, Matthew McKinley, Molly Stewart, Jeffrey S. Novak, Ronald E. Greenberg, Keith Sultan, Bethany Devito, Mary Cheung, Maurice A. Cerulli, Larry S. Miller, Divyesh V. Sejpal, Anil K. Vegesna, Arvind J. Trindade
Background and Aims Volumetric laser endomicroscopy (VLE) is a new wide field advanced imaging technology for Barrett’s esophagus (BE). No data exist on incremental yield of dysplasia detection. Our aim is to report the incremental yield of dysplasia detection in BE using VLE. Methods This is a retrospective study from a prospectively maintained database from 2011-2017 comparing the dysplasia yield of 4 different surveillance strategies in an academic BE tertiary care referral center. The groups were (1) random biopsies (RB), (2) Seattle protocol random biopsies (SP), (3) VLE without laser marking (VLE) and (4) VLE with laser marking (VLEL). Results A total of 448 consecutive patients (79 RB, 95 SP, 168 VLE, and 106 VLEL) met inclusion criteria. After adjusting for visible lesions, the total dysplasia yield was 5.7%, 19.6%, 24.8%, and 33.7%, respectively. When compared with just the SP group, VLEL group had statistically higher rates of overall dysplasia yield (19.6 % vs 33.7%, p=0.03; OR 2.1, p=0.03). The RB and VLE groups did not have statistically significant differences in dysplasia detection compared with the SP group. Both VLEL and VLE groups have statistically significant differences in neoplasia (high-grade dysplasia and intramucosal cancer) detection compared with the SP group (14% vs 1%, p=0.001 and 11% vs 1%, p=0.003). Conclusion A surveillance strategy involving VLEL lead to statistically significant higher yield of dysplasia and neoplasia detection compared with a standard random biopsy protocol. These results support the use of VLEL for surveillance in BE in academic centers.
Hot snare polypectomy with or without saline solution/epinephrine lift for the complete resection of small colorectal polyps Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-02 Hyun-Soo Kim, Ho Yeon Jung, Hong Jun Park, Hee Man Kim, Jae Ho Seong, Yong Seok Kang, Mee Yon Cho, Min Heui Yu, Dae Ryong Kang
Background /Aim: The criterion standard polypectomy technique for the complete removal of small colorectal polyps has not yet been established. This study aimed to compare the complete resection rate of hot snare polypectomy (HSP) with that of endoscopic mucosal resection (EMR) for small, sessile, or flat polyps. Methods Patients with 5–9-mm non-pedunculated colorectal polyps were prospectively randomized to the HSP or EMR group. The presence of residual polyps was assessed by performing histological assessment of 4-quadrant forceps biopsies taken from the edges of the polypectomy site. The primary outcome was the complete resection rate after HSP or EMR, whereas the secondary outcomes were the proportion of procedure-related adverse events and specimen-loss rate. Sample size was estimated using a superiority trial design. We assumed that the complete resection rate of the EMR group would be at least 8% higher than the HSP group. Results A total of 382 polyps in 269 patients were assessed and randomly assigned to each method using 4 × 4 block randomization. Among them, 353 polyps were finally analyzed based on pathological results. The mean polyp size was 6.3 ± 1.3 mm. The complete resection rate did not differ between the HSP and EMR groups (88.4% [152/172] vs 92.8% [168/181], respectively; P = 0.2). The intraprocedural bleeding, immediately after polypectomy, was significantly higher in the HSP group than in the EMR group (5.2% vs 0.6%, respectively; P = 0.009). However, clinically significant bleeding and tissue retrieval failure rates did not differ between the groups. In the multivariate logistic regression analysis, the sessile serrated adenoma/polyp (SSA/P) or hyperplastic polyp (HP) was almost three times (odds ratio [OR], 2.824; 95% confidence interval [CI], 1.03–7.75; P = 0.044) more likely to be incompletely resected compared to other conventional adenomatous polyps. Except for pathology, we found no significant independent predictors for incomplete resection. Conclusion EMR for small non-pedunculated colorectal polyps is not superior to HSP in terms of complete resection or safety. Both methods can be performed according to the endoscopist’s preference.
Outcomes of Endoscopic Intervention for Overt Gastrointestinal Bleeding in Severe Thrombocytopenia Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-02-02 Guilherme Piovezani Ramos, Moritz Binder, Paul Hampel, Manuel Bonfim Braga Neto, Dharma Sunjaya, Badr Al Bawardy, Barham K. Abu Dayyeh, Navtej S. Buttar, David H. Bruining, Nayantara Coelho-Prabhu, Mark V. Larson, Louis M. Wong Kee Song, Elizabeth Rajan
Background and Aims Gastrointestinal bleeding (GIB) in the setting of thrombocytopenia raises concerns about endoscopic procedure risk. We aimed to assess the safety and outcomes of endoscopy for overt GIB in the setting of severe thrombocytopenia in liver cirrhosis (LC) and non-liver cirrhosis (NLC). Methods Retrospective study on inpatients who underwent endoscopy within 24-hours of presentation for overt GIB with a platelet count (PC) of 20 to <50 x 103/mL. Outcomes included diagnostic and therapeutic yields, procedural adverse events, packed red blood cell (pRBC) and platelet transfusions, recurrent bleeding rate, all-cause and GIB-related mortality. Results 144 patients were identified. Median PC was 41 x 103/mL and 61% had LC. The diagnostic yield was 68% (LC=61%, NLC=79%, p=0.04). Therapeutic yield was 60% (59% vs 60%, p=1.00). Initial hemostasis rate was 94% with one adverse event. The median number of pRBC and platelet transfusions decreased after intervention in the entire cohort. Recurrent bleeding rates were 22% at 1 month and 30% at 1 year, with no difference between groups. An elevated INR >2 was a predictor of recurrent bleeding. All-cause mortality was 19% at 1 month and 37% at 1 year, whereas GIB-associated mortality in our cohort was only 3% at 1 month and 4% at 1 year, with no significant difference between LC and NLC. Predictors of mortality were INR >2, aPTT >38s, hypotension, ICU admission, and pulmonary comorbidities. Conclusion In this study cohort, we observed that endoscopy for overt GIB in the setting of severe thrombocytopenia in both LC and NLC patients appears safe, has moderate diagnostic and therapeutic yields with high initial hemostasis rate, and is associated with a significant decrease in pRBC and platelet transfusions. Recurrent bleeding and all-cause mortality rates remain high.
Magnetic anchor-guided endoscopic submucosal dissection for gastric lesions (with video) Gastrointest. Endosc. (IF 6.501) Pub Date : 2018-01-17 Ippei Matsuzaki, Masashi Hattori, Ken Hirose, Masaya Esaki, Masakatsu Yoshikawa, Takio Yokoi, Makoto Kobayashi, Ryoji Miyahara, Yoshiki Hirooka, Hidemi Goto
Background and Aim The feasibility of magnetic anchor-guided endoscopic submucosal dissection (MAG-ESD) using a neodymium magnet for gastric lesions has not been clarified. The aim of study was to evaluate the feasibility of MAG-ESD using neodymium magnets while treating gastric lesions. Methods This prospective trial was conducted at the Yamashita Hospital. The MAG-ESD was performed for 50 gastric lesions using an insulated-tip knife. The magnetic anchor consisted of an internal neodymium magnet attached to a hemoclip with 3-0 silk. The external and internal magnets were made from the neodymium magnet. The feasibility of traction using MAG-ESD, en bloc resection rate, complete en bloc resection rate, time required for preparation and attaching the magnetic anchor, procedure time, rate of retrieval of the magnetic anchors and adverse events were evaluated. Results Fifty patients (median lesion size 20 mm; range 5-100 mm) were enrolled. MAG-ESDs were successfully performed for all 50 gastric lesions. Adequate counter traction was obtained using the external magnet. En bloc resections were achieved and complete en bloc resections confirmed in all cases without adverse events. Attaching the magnetic anchor required a median of 6 minutes (range 2-14 minutes). The median procedure time was 49 minutes (range 15-301 minutes), and the magnetic anchors could be retrieved in all cases. Conclusion This study clearly demonstrated the feasibility of this MAG-ESD in the stomach. We hope that this procedure will facilitate the resection of difficult lesions.
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