Simethicone is retained in endoscopes despite reprocessing: impact of its use on working channel fluid retention and adenosine triphosphate bioluminescence values (with video) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-08-17 Monique T. Barakat, Robert J. Huang, Subhas Banerjee
Background Studies from our group and others demonstrate residual fluid in 42% to 95% of endoscope working channels despite high-level disinfection (HLD) and drying. Additionally, persistent simethicone has been reported in endoscope channels despite reprocessing. Methods Endoscopy was performed using water or varied simethicone concentrations (0.5%, 1%, 3%) for flushing. After HLD/drying, we inspected endoscope working channels for retained fluid using the SteriCam borescope. Working channel rinsates were evaluated for adenosine triphosphate (ATP) bioluminescence. Fourier transform infrared spectroscopy was performed on fluid droplets gathered from a colonoscope in which low-concentration simethicone was used. Results Use of medium/high concentration simethicone resulted in higher mean fluid droplets (13.5/17.3 droplets, respectively) and ATP bioluminescence values (20.6/23 RLUs, respectively) compared with procedures using only water (6.3 droplets/10.9 RLUs, p<0.001). Two automated endoscope reprocessing (AER) cycles resulted in return of fluid droplet and ATP bioluminescence values to ranges similar to procedures using only water (p=0.56). Low-concentration simethicone did not increase mean residual fluid or ATP bioluminescence values compared with procedures using only water (5.8 droplets/15.6 RLUs). FTIR analysis revealed simethicone in the endoscope working channel after use of low-concentration simethicone. Conclusions Use of medium/high concentration simethicone is associated with retention of increased fluid droplets and higher ATP bioluminescence values in endoscope working channels, compared with endoscopes in which water or low concentration simethicone was used. However, simethicone is detectable in endoscopes despite reprocessing, even when used in low concentration. Our data suggest that when simethicone is used, it should be used in the lowest concentration possible. Facilities may consider 2 AER cycles for reprocessing of endoscopes when simethicone has been used.
Efficacy of low-temperature plasma activated gas disinfection against biofilm on contaminated GI endoscope channels Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-08-16 Sudhir Bhatt, Poonam Mehta, Chen Chen, Christina L. Schneider, Lauren N. White, Hai-Lan Chen, Michael G. Kong
BackgroundIt has been increasingly recognized that the safety of gastrointestinal endoscopes needs to be improved by addressing the small margin of safety of high-level disinfectants (HLD), and the failure of HLD to clear multi-drug resistant organisms and biofilms. There is also an unmet need for effective low-temperature sterilization techniques that have a clear pathway for FDA clearance. Here, we report the results of our investigation of a novel argon plasma-activated gas (PAG) for disinfection and potentially sterilization of biofilm-contaminated endoscopic channels.MethodsTest PTFE channel segments were contaminated with 4-, 24- and 48-hour luminal biofilms of MRSA, P aeruginosa or E coli and were treated by PAG flowing for up to 9 minutes. After PAG treatment, inactivation and dispersal of luminal bacterial biofilms as well as their regrowth in 48 hours were evaluated. Reactive species induced by PAG were measured with colorimetric probes and electron spin resonance spectrometry. Surface morphology and elemental composition of PAG-treated channel material were analyzed with scanning electron microscopy.ResultsPAG treatment for 9 minutes led to more than 8 log reduction of viable cells and dispersal of 24- and 48-hour luminal biofilms of all 3 bacteria and to suppression of their regrowth, whereas it resulted in little morphological abnormalities in channel material. Ozone concentration of PAG fell to below 0.01 ppm within 30 seconds of switching off the plasma. PAG-treated deionized water was acidified with numerous types of reactive species, each with a concentration some 3 orders of magnitude or more below its bacterial inhibition concentration.ConclusionsPAG is capable of effectively and rapidly disinfecting luminal bacterial biofilms and offers an alternative to the step of HLD and/or ethylene oxide in the endoscope reprocessing procedure with safety to personnel and environment.
A prospective pilot comparison of wet and dry heparinized suction for EUS-guided liver biopsy (with videos) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-08-16 Shaffer R.S. Mok, David L. Diehl, Amitpal S. Johal, Harshit S. Khara, Bradley D. Confer, Prashant R. Mudireddy, H. Lester Kirchner, Zong-Ming E. Chen
Background and AimsAs EUS-guided liver biopsy (EUS-LB) becomes more widely used, further studies have investigated ways to improve tissue yields. Use of a heparin primed needle may lead to less clotting of blood within the needle, improve tissue recovery, and decrease fragmentation. The purpose of this study was to prospectively evaluate wet suction using a heparin primed needle for EUS-LB.MethodsThis was a prospective cross-over study evaluating wet suction for EUS-LB in parenchymal liver disease. The primary outcome was specimen adequacy, defined by an aggregate specimen length (ASL) >15mm and >5 complete portal tracts (CPTs). Secondary outcomes included number of CPTs, length of the longest piece (LLP), ASL, and number of small (<4mm), medium (5-8mm) and large (>9mm) fragments. Adverse events were tracked at 7 and 30 days.Results120 biopsy specimens were collected from 40 participants (3 specimens per patient). Specimen adequacy occurred in 39 wet heparin (98%), 37 dry heparin (93%), and 30 dry needle biopsies [80%; p=0.01, 95%confidence interval (CI), 0.14-0.18]. There was no difference between dry needle techniques. LLP was 8.9 mm for wet heparin, and 5.8 mm for dry techniques (p=0.003; 95% CI, 0.33-1.53). ASL was 49.2mm for wet heparin, and 23.9mm for the dry (p=0.003; 95% CI, -46.34 to 44.94). Mean CPT count was 7.0 for wet heparin versus 4.0 for dry (p=0.01; 95% CI, 0.74-6.26). There were more medium (2.0 versus 1.0; p = 0.03; 95% CI, 0.06-1.24) and large (1.0 versus 0.0; p=0.003; 95% CI, 0.33-1.53) fragments with wet suction with no difference in small fragments between groups.ConclusionsThe use of wet suction EUS-LB demonstrated improved tissue adequacy compared with dry needle techniques.
EUS-guided celiac ganglion radiofrequency ablation versus celiac plexus neurolysis for palliation of pain in pancreatic cancer: a randomized controlled trial (with videos) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-08-16 Ji Young Bang, Bryce Sutton, Robert H. Hawes, Shyam Varadarajulu
Background and AimsAlthough frequently performed, the efficacy of endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) for palliation of pain in pancreatic cancer is suboptimal. Recently, endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) has been proposed as a palliative treatment option for pancreatic neoplasms. We performed a single-blind, randomized trial to compare the effectiveness of EUS-CPN and EUS-RFA for palliation of pain in pancreatic cancer.MethodsPatients with abdominal pain due to locally advanced or metastatic pancreatic cancer underwent EUS-CPN (n=14) or EUS-RFA (n=12). EUS-RFA was performed using a 1F monopolar probe passed via a 19-gauge FNA needle, by targeting the area of celiac plexus or visualized ganglia. Primary outcome was pain severity as measured by the European Organization for Research and Treatment of Cancer (EORTC) pancreatic cancer-specific (QLQ-PAN26) questionnaire administered pre-treatment and at 2 and 4 weeks post-treatment. Secondary outcome measures were comparison of quality of life as determined by PAN26 and C30 (core cancer) questionnaires and opioid analgesia use between the 2 groups.ResultsBoth the pancreatic cancer-specific (49.0 vs 57.0, p<0.001) and core cancer (51.9 vs 64.4, p=0.032) questionnaires revealed less pain for EUS-RFA over EUS-CPN. Also, EUS-RFA cohort experienced significantly less severe gastrointestinal symptoms, were able to plan more for the future, and had better emotional functioning compared with the EUS-CPN group.ConclusionsCompared with EUS-CPN, EUS-RFA provided more pain relief and improved the quality of life for patients with pancreatic cancer. ClinicalTrials.gov Identifier: NCT03152487
The diagnostic outcomes of esophageal cancer by artificial intelligence using convolutional neural networks Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-08-16 Yoshimasa Horie, Toshiyuki Yoshio, Kazuharu Aoyama, Syouichi Yoshimizu, Yusuke Horiuchi, Akiyoshi Ishiyama, Toshiaki Hirasawa, Tomohiro Tuchida, Tsuyoshi Ozawa, Soichiro Ishihara, Youichi Kumagai, Mitsuhiro Fujishiro, Iruru Maetani, Junko Fujisaki, Tomohiro Tada
Background and AimsThe prognosis of esophageal cancer is relatively poor. Patients are usually diagnosed at an advanced stage when it is often too late for effective treatment. Recently, artificial intelligence (AI) using deep learning has made remarkable progress in medicine. However, there are no reports on its application for diagnosing esophageal cancer. Here, we demonstrate the diagnostic ability of AI to detect esophageal cancer including squamous cell carcinoma and adenocarcinoma.MethodsWe retrospectively collected 8428 training images of esophageal cancer from 384 patients, at the Cancer Institute Hospital, Japan. Using these, we developed deep learning through convolutional neural networks (CNNs). We also prepared 1118 test images for 47 patients with 49 esophageal cancers and 50 patients without esophageal cancer to evaluate the diagnostic accuracy.ResultsThe CNN took 27 seconds to analyze 1118 test images and correctly detected esophageal cancer cases with a sensitivity of 98%. CNN could detect all 7 small cancer lesions less than 10 mm in size. Although the positive predictive value for each image was 40%, misdiagnosing shadows and normal structures led to a negative predictive value of 95%. The CNN could distinguish superficial esophageal cancer from advanced cancer with an accuracy of 98%.ConclusionsThe constructed CNN system for detecting esophageal cancer can analyze stored endoscopic images in a short time with high sensitivity. However, more training would lead to higher diagnostic accuracy. This system can facilitate early detection in practice, leading to a better prognosis in the near future.
Quantitative assessment of mucosal architecture using computer-based analysis of confocal laser endomicroscopy in inflammatory bowel diseases Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-08-16 L. Quénéhervé, G. David, A. Bourreille, J.B. Hardouin, G. Rahmi, N. Neunlist, J. Brégeon, E. Coron
Background and AimsConfocal endomicroscopy (CLE) might discriminate mucosal lesions between Crohn’s disease (CD) and ulcerative colitis (UC). However, the analysis of CLE images requires time-consuming methods, a long training time and potential impediments, such as significant interobserver variability. Therefore, we developed a computer-based method to analyze mucosal architecture from CLE images and discriminate between healthy subjects and patients with inflammatory bowel disease (IBD) as well as between UC and CD patients.MethodsWe retrospectively screened patients who had undergone CLE either for an evaluation of an IBD in remission or for colorectal cancer screening (controls) between 2009 and 2016. We assessed 14 morphological and functional parameters in each CLE recording from 23 CD patients, 27 UC patients and 9 control patients. Next, we constructed 2 scores, one for the IBD diagnosis (IBDiag) and the other for the differential diagnosis between UC and CD (IBDif).ResultsIn IBD patients, the mean intercrypt distance, wall thickness and fluorescein leakage through the colonic mucosa were significantly increased compared with control patients by 155%, 188%, and 297%, respectively (p<0.05). In UC patients, the same parameters were significantly increased by 109%, 117%, and 174%, respectively (p<0.05), compared with CD patients. IBDiag had 100% [93%;100%] sensitivity and 100% [66%;100%] specificity. IBDif provided discrimination of UC from CD patients with 92% [75%;99%] sensitivity and 91%[72%;99%] specificity.ConclusionsConfirming these results using prospective validation cohorts can substantiate that computer-based analysis of CLE images may provide new biomarkers for the diagnosis and the characterization of IBD.
Endoscopic sinusotomy versus redo surgery for the treatment of chronic pouch anastomotic sinus in ulcerative colitis patients Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-08-11 Nan Lan, Tracy H. Hull, Bo Shen
Background and Aims Pouch sinus may be a serious adverse event in patients undergoing ileal pouch-anal anastomosis. The aim of this study was to compare endoscopic sinusotomy and redo pouch surgery in the management of pouch sinus. Methods All consecutive ulcerative colitis patients with chronic pouch sinuses treated with endoscopic sinusotomy versus redo surgery from 2006 to 2016 were identified. The primary outcomes were recurrence-free and surgery-free survivals. The secondary outcome was postprocedural adverse events. Results This historical cohort study included a total of 226 patients (endoscopic sinusotomy, N = 141 and redo surgery, N = 85). Complete healing of the sinus was achieved in 75 (53.2%) patients, partial healing was seen in 23 (16.3%) patients with endoscopic sinusotomy and an initial complete healing, ie, no anastomotic leak before ileostomy closure was obtained in 80 (94.1%) patients receiving redo surgery. Sinus recurrence after complete healing was seen in 17 (22.7%) endoscopic sinusotomy-treated patients and 28 (32.9%) surgery-treated patients (P=0.15). Subsequent surgery was needed in 34 (24.1%) patients with endoscopic sinusotomy therapy and 18 (21.2%) patients with initial redo surgery (P=0.70). Kaplan-Meier recurrence-free and surgery-free survivals after initial procedure showed no statistical difference between the 2 groups (P=0.42 and P=0.65, respectively). The rate of adverse events in the endoscopic sinusotomy group was significantly lower than that in the surgery group (2.5% vs 43.5%, P<0.0001). Conclusions Recurrence-free survival and surgery-free survival were comparable between patients treated with endoscopic sinusotomy and redo surgery, whereas pouch redo surgery was found to be associated with a higher immediate complete healing rate yet a higher morbidity.
Utility of video capsule endoscopy for longitudinal monitoring of Crohn’s disease activity in the small bowel: a prospective study Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-08-04 Gil Y. Melmed, Marla C. Dubinsky, David T. Rubin, Mark Fleisher, Shabana F. Pasha, Atsushi Sakuraba, Felix Tiongco, Ira Shafran, Ignacio Fernandez-Urien, Bruno Rosa, Neofytos P. Papageorgiou, Jonathan A. Leighton
Background and Aims This prospective, multicenter study evaluated small-bowel capsule endoscopy (CE) for the longitudinal assessment of mucosal inflammation in subjects with Crohn’s disease (CD). Methods Subjects with known CD underwent clinical evaluation with ileocolonoscopy and CE at baseline and 6-month follow-up. Small-bowel patency was confirmed before CE at both time points. The Simple Endoscopic Score for CD (SES-CD) was used for ileocolonoscopy, and the Lewis score and the Capsule Endoscopy CD Endoscopic Index of Severity (CECDEIS) were used for CE. Clinical scoring indices included the Physician Global Assessment (PGA), CD Activity Index (CDAI), and Harvey-Bradshaw Index (HBI). Laboratory markers including C-reactive protein (CRP), fecal calprotectin (FC), and erythrocyte sedimentation rate (ESR) were collected at baseline and follow-up. Correlation between endoscopic scores and clinical parameters were measured using Spearman tests. Results A total of 74 subjects were enrolled, of whom 53 (72%) completed endoscopic procedures at baseline and 6-month follow-up. The SES-CD ileocolonoscopy score correlated with the Lewis (p<0.001, ρ=0.59) and CECDEIS capsule scores (p=0.002, ρ=0.48). None of the 3 endoscopic scores correlated with PGA, CDAI, HBI, CRP, ESR, or FC. Approximately 85% of subjects had proximal small-bowel inflammation identified on CE. There were no CE-related adverse events (AEs). Conclusions There was high correlation between CE and ileocolonoscopy scores for the assessment of mucosal disease activity over time; however, there were no correlations between endoscopic scores and clinical parameters. The use of serial capsule endoscopy for the assessment of small-bowel CD is feasible and valid. (www.clinicaltrials.gov; NCT01942720)
Spigelman Stage IV Duodenal Polyposis Does Not Precede a Majority of Duodenal Cancer Cases in Patients with Familial Adenomatous Polyposis Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-08-03 Sushrut S. Thiruvengadam, Rocio Lopez, Margaret O’Malley, Lisa LaGuardia, James M. Church, Matthew Kalady, R. Matthew Walsh, Carol A. Burke
Background and AimsThe greatest known risk factor for duodenal cancer in FAP is Spigelman Stage (SS) IV duodenal polyposis. Endoscopic surveillance is recommended in FAP patients with SS 0-IV and prophylactic duodenectomy should be considered in SS IV. Cancer occurs in patients without SS IV polyposis. We assessed the relationship of SS and other factors with duodenal cancer in FAP.MethodsWe performed a case-control study on 18 FAP patients with duodenal cancer and 85 randomly selected FAP controls with similar age characteristics. Demographic, clinical and endoscopic features were compared using univariate and logistic regression analyses to assess factors associated with duodenal cancer.ResultsFifty-three percent of cases had no SS IV history. SS components positively associated with cancer included duodenal polyp size (77% vs 47%, P = .015), and high-grade dysplasia (HGD) (29% vs 6%; P = 0.003), but not polyp number or histology. In the papilla, the frequency of tubulovillous or villous histology (80% vs 22%; P < .001) and HGD (30% vs 4%; P = .010) was greater in cases than controls.ConclusionsSS IV polyposis was absent in half of FAP patients with duodenal cancer. Only 2 of 4 SS components (large duodenal polyp size and HGD) were positively associated with duodenal cancer. Advanced pathology of the papilla appears to be an important feature. Revision of SS to emphasize these findings should be considered to better estimate cancer risk.
Radiofrequency ablation compared with argon plasma coagulation after endoscopic resection of high-grade dysplasia or T1 adenocarcinoma in Barrett’s esophagus: a randomized pilot study (BRIDE) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-08-01 Mohammad Farhad Peerally, Pradeep Bhandari, Krish Ragunath, Hugh Barr, Rehan Haidry, Laurence Lovat, Howard Smart, Rebecca Harrison, Clive Stokes, Karen Smith, Tom Morris, John S. de Caestecker
Background and aimsEndoscopic resection (ER) is safe and effective for Barrett’s esophagus (BE) containing high-grade dysplasia (HGD) or mucosal adenocarcinoma (T1A); risk of metachronous neoplasia is reduced by ablation of residual BE using radiofrequency ablation (RFA) or argon plasma coagulation (APC). These have not been directly compared. We aimed to recruit up to 100 patients with BE and HGD or T1A confirmed by ER over 1 year in 6 centres in a randomized pilot study.MethodsRandomization was 1:1 to RFA or APC (4 treatments allowed at 2 month intervals); recruitment, retention, dysplasia clearance, clearance of benign BE, adverse events, healthcare costs, and quality of life (QoL) using EQ-5D, EORTC QLQ-C30, OES18 were assessed up to the end of the trial at 12 months.ResultsOf 171 patients screened, 76 were randomized to RFA (n=36) or APC (n=40); mean age was 69.7, 82% male. BE was <5 cm (n=27), 5 to 10 cm (n=45), and >10 cm (n=4). Sixty-five patients completed the trial. At 12 months, dysplasia clearance was RFA 79.4% and APC 83.8% (OR, 0.7; 95% CI, 0.2-2.6); BE clearance was RFA 55.8%, and APC 48.3% (OR, 1.4; 95% CI, 0.5-3.6). A total of 6.1% (RFA) and 13.3% (APC) had buried BE glands. Adverse events (including stricture rate after starting RFA 3/36 [8.3%] and APC 3/37 [8.1%]) and QoL scores were similar, but RFA cost £21,147 more per case than APC.ConclusionThis pilot suggests similar efficacy and safety but a cost difference favoring APC. A fully powered non-inferiority trial is appropriate to confirm these findings.
EUS-guided antegrade intervention for benign biliary diseases in patients with surgically altered anatomy (with videos) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-08-01 Shuntaro Mukai, Takao Itoi, Atsushi Sofuni, Takayoshi Tsuchiya, Reina Tanaka, Ryosuke Tonozuka, Mitsuyoshi Honjo, Mitsuru Fujita, Kenjiro Yamamoto, Yuichi Nagakawa
Background and AimsAlthough balloon enteroscopy-assisted ERCP (BE-ERCP) is effective and safe for benign biliary diseases in patients with surgically altered anatomy (SAA), BE-ERCP is not always successful. Recently, EUS-guided antegrade intervention (EUS-AI) including a 1-stage or 2-stage procedure has been developed for BE-ERCP failure cases. The aim of the present study was to evaluate the outcome of EUS-AI for benign biliary diseases with SAA.MethodsOf 48 patients in whom BE-ERCP failed, percutaneous transhepatic intervention was performed in 11 patients. Another 37 patients who failed BE-ERCP and underwent EUS-AI for benign biliary diseases with SAA [common bile duct stones (n = 11), intrahepatic bile duct stones (n = 5), anastomotic stricture (n = 21)] from November 2013 until November 2017 were retrospectively reviewed.ResultsThe overall technical success of the creation of hepaticoenteric tract by EUS was 91.9% (34/37). Moderate adverse events were observed in 8.1% (biliary peritonitis [n=3]). One-stage EUS-AI by EUS succeeded in 8 cases (100%) without any adverse events. In another 26 cases, 2-stage EUS-AI by ERCP was performed about 1 or 2 months later. Endoscopic antegrade therapy under fluoroscopy was successful in 6 cases. Per-oral cholangioscopy-assisted antegrade intervention were required in 19 cases (guidewire manipulation across the anastomotic stricture [n=6], cholangioscopy-guided lithotripsy using electrohydraulic lithotripsy [n=13]). In 1 case, magnetic compression anastomosis was performed. The final clinical success rate of all EUS-AI was 91.9%.ConclusionsEUS-AI for benign biliary diseases with SAA appears to be a feasible and safe alternative procedure after BE-ERCP failure.
Performance Indicators in Colonoscopy after Certification for Independent Practice: Outcomes and Predictors of Competence Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-08-01 Keith Siau, James Hodson, Roland M. Valori, Stephen T. Ward, Paul Dunckley
BackgroundRobust real-world performance data of newly independent colonoscopists are lacking. In the United Kingdom, provisional colonoscopy certification (PCC) marks the transition from training to newly independent practice. We aimed to assess changes in key performance indicators (KPIs) such as cecal intubation rate (CIR) in the periods pre- and post-PCC, particularly regarding rates and predictors of trainees exhibiting a drop-in performance (DIP), defined as CIR <90% in the first 50 procedures post-PCC.MethodsA prospective United Kingdom-wide observational study of JETS e-Portfolio colonoscopy entries (N=257,800) from trainees awarded PCC between July 2011-2016 was undertaken. Moving average analyses were used to study KPI trends relative to PCC. Pre-PCC trainee, trainer and training environment factors were compared between DIP and non-DIP cohorts to identify predictors of DIP.ResultsSeven hundred thirty-three trainees from 180 centers were awarded PCC after a median of 265 procedures and 3.1 years. Throughout the early post-PCC period, average CIR surpassed the national 90% standard. Despite this, not all trainees achieved this standard post-PCC, with DIP observed in 18.4%. DIP was not influenced by trainer presence and diminished after 100 additional procedures. On multivariable analysis, pre-PCC CIR and trainer specialty were predictive of DIP. Trainees with DIP incurred higher post-PCC rates of moderate-severe discomfort despite requiring higher analgesic dosages and were more likely to require trainer assistance in failed procedures.ConclusionsThe current PCC requirements are appropriate for diagnostic colonoscopy. It is possible to identify predictors of underperformance in trainees, which may be of value to training leads and could improve patient experience.
Choosing the right through-the-scope clip: a rigorous comparison of rotatability, whip, open/close precision, and closure strength (with videos) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-27 Thomas J. Wang, Hiroyuki Aihara, Andrew C. Thompson, Allison R. Schulman, Christopher C. Thompson, Marvin Ryou
Background and Aims Many new through-the-scope (TTS) clips are available, and physicians often select clips based on physical characteristics and/or cost However, functional profiles may be equally important and have not been methodically assessed. We evaluated 5 commercially available clips: Resolution 360, Instinct, Quick Clip Pro, Dura Clip, and SureClip. Methods We rigorously compared clips on multiple characteristics, including rotatability, overshoot, open/close precision, and tensile/closure strength. Clips were tested in 4 different endoscope configurations: (1) straight, (2) duodenal sweep, (3) full retroflexion, and (4) across the duodenoscope elevator. Results Rotatability: The Resolution 360 was the fastest due to its unique functionality in allowing primary MD control in rotation (p<0.05). The Resolution 360, SureClip, and Dura Clip were able to rotate through the prescribed sequence across all scope configurations. Overshoot: The SureClip and Resolution 360 had the least overshoot for the straight configuration at 0%. All clips had >75% overshoot at more strained configurations. Open/close precision: The SureClip and Dura Clip showed precise opening/closing with the ability to stop at any point. The remaining clips exhibited abrupt opening with more controlled closure. Tensile strength: The Quick Clip Pro generated the highest peak force as would be required in lateral tissue manipulation (4.8 lbs, p<0.005). Closure strength: The Instinct overall showed the most gel compression, and along with the Resolution 360, 100% deployment success for all gel tissue thicknesses (up to 10mm). Conclusions Each clip has a unique physical and functional profile which may factor into selection depending on the clinical circumstance.
Clinical impact of closure of the mucosal defect after duodenal endoscopic submucosal dissection Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-25 Motohiko Kato, Yasutoshi Ochiai, Seiichiro Fukuhara, Tadateru Maehata, Motoki Sasaki, Yoshiyuki Kiguchi, Teppei Akimoto, Ai Fujimoto, Atsushi Nakayama, Takanori Kanai, Naohisa Yahagi
Background and Aims Delayed adverse events (bleeding or perforation) are major concerns associated with duodenal endoscopic submucosal dissection (ESD). The aim of this study was to assess the efficacy of prophylactic closure of the mucosal defect after duodenal ESD. Methods This is a retrospective study from a university hospital. One hundred sixty-eight patients (173 lesions) who underwent duodenal ESD between July 2010 and June 2017 were included in this study. The study subjects were divided into 3 subgroups according to the degree of closure: complete group, incomplete group, and unclosed group. The proportion of delayed adverse events, maximum serum level of C-reactive protein (CRP), and total length of hospital stay were compared among these subgroups. Moreover, a multivariate logistic regression model to identify the risk factors for delayed adverse events was constructed. Results The proportion of delayed adverse events in the complete group, incomplete group, and unclosed group were 1.7%, 25%, and 15.6%, respectively. The difference between complete group and the other groups was significant (p<0.01). The maximum serum CRP level was much lower (1.51±2.18 mg/dL vs 6.28±10.0 mg/dL, p<0.01), and the length of hospital stay was significantly shorter in the complete group than in incomplete/unclosed group (median [range] 5 [5-14] days vs 8 [4-59] days, p<0.01). Multivariate analysis revealed that complete closure revealed significant decrease of delayed adverse events (OR, 0.055; 95% CI, 0.01-0.29; p<0.01) and lesion locating distal from descending part revealed statistic tendency of increase of delayed adverse events (OR, 4.48; 95% CI, 0.85-23.6; p=0.08). Conclusion The present study revealed that complete closure of the mucosal defect after duodenal ESD significantly decreased delayed adverse events and improved other outcomes.
Detection of mesenteric ischemia by means of endoscopic visible light spectroscopy after luminal feeding Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-25 Louisa J.D. van Dijk, Jihan Harki, Desirée van Noord, Annemarie C. de Vries, Adriaan Moelker, Hence J.M. Verhagen, Ernst J. Kuipers, Marco J. Bruno
Background and Aims Endoscopic visible light spectroscopy (VLS) enables measurement of mucosal oxygen saturation during upper GI endoscopy and is used in the diagnostic work-up of chronic mesenteric ischemia (CMI). Currently, VLS is performed when the patient has fasted. We aimed to determine whether food challenge improves the diagnostic performance of VLS measurements for the diagnosis of CMI. Methods Single center prospective study in healthy controls and consecutive patients suspected of CMI and referred to a Dutch specialized CMI center for standardized diagnostic CMI work-up. Immediately after performance of conventional fasted VLS measurements, luminal feeding was administered and 45 minutes thereafter VLS measurements were performed again. Patients were classified as CMI if a multidisciplinary expert based consensus diagnosis of CMI was established and successful revascularization therapy resulted in symptom relief. Patients were classified as no-CMI when consensus diagnosis was not reached or when symptom relief did not occur after technically successful treatment. Results We included 60 CMI-suspected patients and 16 healthy controls. Duodenal oxygen saturation was significantly higher postprandially compared to fasting state in healthy controls (median (IQR) pre 54% (49-56), post 56% (53-58), p=0.02), no-CMI patients (pre 55% (51-57), post 57% (53-59), p>0.01), as well as CMI patients (pre 51% (48-53), post 54% (50-58), p=0.01). Mucosal oxygen saturations did not significantly increase postprandially in the duodenal bulb or antrum of the stomach. Neither absolute postprandial oxygen measurements nor the absolute or relative difference between preprandial versus postprandial oxygen measurements provided additional discriminative ability for the diagnosis of CMI. Conclusions Postprandial VLS measurements have no added benefit for the diagnosis of CMI.
Risk Assessment of Lymph Node Metastases in Early Gastric Adenocarcinoma Fulfilling Expanded Endoscopic Resection Criteria Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-24 Fernanda Cristina Simões Pessorrusso, Aloisio Felipe-Silva, Carlos Eduardo Jacob, Marcus Fernando Kodama Pertille Ramos, Venancio Avancini Alves Ferreira, Evandro Sobroza de Mello, Bruno Zilberstein, Ulysses Ribeiro, Fauze Maluf-Filho
Background and Aims Early gastric cancer (EGC) is known to present a low rate of lymph node metastases (LNMs). Gastrectomy with D2 lymphadenectomy is usually curative for EGC. Endoscopic submucosal dissection (ESD) is a well-accepted treatment modality for lesions that meet the classic criteria: those mucosal differentiated adenocarcinoma measuring 20 mm or less, without ulceration. Expanded criteria for ESD have been proposed based on null LNM rate from large gastrectomies series from Japan. Patients with LNM have been reported in Western centers, emerging the need for validation of expanded criteria. Our aim was to assess the risk of LNM in gastrectomy specimens of patients with EGC who met the expanded criteria for ESD. Methods We conducted an evaluation of gastrectomy specimens including LNM staging of patients submitted to gastrectomy for EGC in a 39-year retrospective cohort. Results A total of 389 surgical specimens were included. From them, 135 fulfilled criteria for endoscopic resection. None of the 31 patients with classic criteria had LNM. From the 104 patients with expanded criteria, 3 had LNM (n=104; 2.9%; 95% CI, 0.7% - 8.6%), all of them with undifferentiated tumors without ulceration, measuring less than 20 mm. Conclusions There is a small risk of LNM in EGC when expanded criteria for ESD are met. Refinement of the expanded criteria for the risk of LNM may be desirable in Brazilian cohort. Meanwhile, the decision to complement the endoscopic treatment with gastrectomy will have to take into consideration the individual risk of perioperative morbidity and mortality.
The retrievable puncture anchor traction method for EUS-guided gallbladder drainage: a porcine study Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-23 Kai Zhang, Siyu Sun, Jintao Guo, Sheng Wang, Nan Ge, Xiang Liu, Guoxin Wang
Background and AimsEUS-guided gallbladder drainage (EUS-GBD) is a challenging technique for endoscopists that requires a high level of skill. A very important reason why EUS-GBD is challenging is that the gallbladder can be easily collapsed. In order to resolve this concern, we aimed to develop a retrievable puncture anchor traction (RPAT) method for EUS-GBD. We evaluated and compared the success rate, safety, and outcomes of the RPAT method for EUS-GBD against EUS-GBD without retrievable puncture anchor using a porcine model.MethodsIn total, 16 Bama mini pigs (15-20 kg) were randomly divided into an experimental group (n=8) and a control group (n=8). The RPAT method was performed in the experimental group and EUS-GBD without retrievable puncture anchor was performed in the control group. Incidence of operative adverse events, wound healing, and success rates of EUS-GBD were compared and analyzed between the experimental group and the control group.ResultsAll EUS-GBD procedures were successfully performed in the 8 animals in the experimental group (8/8; 100%). However, in the control group, EUS-GBD was successfully performed only on 4 pigs (4/8; 50%); the remaining 4 pigs died due to EUS-GBD failure caused by gallbladder collapse leading to unsuccessful frontal stent release.ConclusionsRPAT helped increase the success rate of EUS-GBD and could reduce gallbladder collapse. Therefore, we believe this method can be applied to EUS-GBD in the near future. Furthermore, RPAT will enhance the safety of EUS-GBD.
Impact of water exchange colonoscopy on endoscopy room efficiency: a systematic review and meta-analysis Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-23 Sergio Cadoni, Cesare Hassan, Leonardo Frazzoni, Sauid Ishaq, Felix W. Leung
Background and aimsSeparate randomized controlled trials (RCTs) showed water exchange (WE) colonoscopy outperformed other techniques in minimizing insertion pain and optimizing adenoma detection rate. Longer insertion time required for removal of infused water, residual air and feces might have hampered its wider adoption. We evaluate the impact of WE compared with air or carbon dioxide insufflation (GAS) on room turnaround efficiency measured by cecal intubation, withdrawal and total procedure time.MethodsWith a systematic search in Pubmed, Embase and Cochrane Library, we identified RCTs (published before March 18, 2018) that compared WE with GAS. We focused on parameters of turnaround efficiency and patient-centered outcomes.ResultsWe analyzed 8371 subjects from 17 studies. Demographics and indications were comparable. Mean cecal intubation time (minutes ± standard deviation) was WE 12.5±6.1 versus GAS 11.1±7.0, with a mean difference of 1.4±3.4 minutes. Six studies showed significant differences in insertion time, their mean cecal intubation time was WE 11.6±5.1 versus GAS 7.7±5.2, with a mean difference of 3.9±1.1 minutes. Mean withdrawal time was similar. Mean total procedure time was WE 26.0±9.7 versus GAS 24.2±9.6, with mean difference of 1.8±6.2 minutes. All mean procedure times were significantly different. Patient-centered outcomes revealed that patients examined with WE had significantly lower real-time insertion pain score, less need for sedation and higher willingness to repeat the procedure.ConclusionsBased on parameters of procedural time, the impact of WE colonoscopy on endoscopy room turnaround yields an increase in total procedure time of about 2 minutes, and is associated with significant improvement in specific patient-centered outcomes.
Long-term recurrent bleeding risk after endoscopic therapy for definitive colonic diverticular bleeding: band ligation versus clipping Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-20 Naoyoshi Nagata, Naoki Ishii, Mitsuru Kaise, Takuro Shimbo, Toshiyuki Sakurai, Junichi Akiyama, Naomi Uemura
Background and Aims Very few prospective studies with over 100 samples have evaluated the long-term outcomes of endoscopic therapy for colonic diverticular bleeding (CDB). This study sought to elucidate the recurrent bleeding risk of endoscopic band ligation versus clipping for definitive CDB based on stigmata of recent hemorrhage (SRH). Methods Patients emergently hospitalized for acute lower GI bleeding and examined by high-resolution colonoscopy were enrolled. Better visualization of SRH from a diverticulum was obtained using a water jet device. Endoscopic band ligation or clipping was performed as first-line treatment and patients were prospectively followed up after discharge. Results No statistical difference was found between the ligation (n=61) and clipping (n=47) groups in baseline characteristics or follow-up period. The probability of 1-year recurrent bleeding was 11.5% in the ligation group versus 37.0% in the clipping group (P=0.018). No patients required surgery or experienced perforation. One patient experienced diverticulitis the next day in the ligation group. In patients with recurrent bleeding within 7 days, the recurrent bleeding site was the same diverticulum, and ulceration was found in the ligation group on repeat colonoscopy. In patients with recurrent bleeding after 2 months, repeat colonoscopy identified that the recurrent bleeding site was different, and scar formation was seen in the ligation group. The left side of the colon was an independent predictor for recurrent bleeding in the ligation group but not in the clipping group. Conclusions Band ligation for definitive CDB has better outcomes than clipping during long-term follow-up after endoscopic therapy, probably due to complete elimination of the diverticulum. CDB can recur at the same diverticulum in the short-term but at a different diverticulum in the long-term.
Impact of fellow training level on adverse events and operative time for common pediatric GI endoscopic procedures Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-19 Jacob A. Mark, Robert E. Kramer
Background and AimsPrevious studies on pediatric endoscopic training have not examined if adverse events (AEs) are affected by the fellow’s training level in detail. We aimed to determine whether trainee presence and educational level increases AEs or operative time (OT) for pediatric intestinal endoscopy.MethodsProspective observational study of AEs for all endoscopic procedures and retrospective analysis of OT (time of endoscope insertion until removal) for a sample of specified procedures at a tertiary children’s hospital. AEs were categorized by severity grades: 1—home management; 2—outpatient evaluation; 3—hospitalization and/or repeat endoscopy; 4—surgery and/or intensive care unit admission, 5—death.ResultsA total of 15,886 (6,257 with trainee) including 1,627 therapeutic (733 with trainee) procedures were analyzed for AEs. Four hundred thirteen total AEs (2.60%) and 213 (1.34%) AEs grade 2 to 4 were identified. Fellow presence at any training level did not increase AE rates for any procedures. Median OT for 3,762 EGDs decreased from 17 to 11 minutes from the first quarter to the fourth quarter of first-year fellowship, and then remained stable. EGDs without fellows were shorter (9 minutes, p < 0.0001) compared with any training level. Median times of 1,291 colonoscopies with EGD decreased from 55 to 51 to 47 minutes for fellows in the first half, second half of first-year fellowship, and second and third year, respectively. Attendings alone were faster (37 minutes, p < 0.0001).ConclusionsCurrent pediatric endoscopic training for is safe regardless of fellow training level. Trainee efficiency improves during and after fellowship.
Tethered capsule endomicroscopy for unsedated microscopic imaging of the esophagus, stomach, and duodenum in humans (with video) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-19 Michalina J. Gora, Lucille Quénéhervé, Robert W. Carruth, Weina Lu, Mireille Rosenberg, Jenny S. Sauk, Alessio Fasano, Gregory Y. Lauwers, Norman S. Nishioka, Guillermo J. Tearney
BackgroundPatients with many different digestive diseases undergo repeated esophagogastroduodenoscopy throughout their life. Tethered capsule endomicroscopy (TCE) is a less invasive method for obtaining high-resolution images of the gastrointestinal mucosa for diagnosis and treatment planning of diseases. In this paper, we present our results from a single center, aimed at testing the safety and the feasibility of TCE for imaging the esophagus, stomach, and duodenum.MethodsAfter swallowed by an unsedated subject, the tethered capsule obtains cross-sectional 10-μm-resolution optical coherence tomography images as the device traverses the alimentary tract. After imaging, the device is withdrawn through the mouth, disinfected, and reused. Safety and feasibility of TCE were tested, focusing on imaging the esophagus of healthy volunteers and patients with Barrett’s esophagus, and duodenum of healthy volunteers. Images were compared to endoscopy and histopathology findings when available.ResultsThirty-eight patients were enrolled. No adverse effects were reported. TCE device swallowing rate was 34 out of 38 (89%). The appearance of physiologic upper gastrointestinal wall, including its microscopic pathology was visualized in esophagus of BE subjects with and without endoscopic evidence of hiatal hernia, as well as in duodenum with a tissue coverage of 85.4 % ± 14.9 %, 90.3 % ± 6.8 % and 84.8% ± 7.4% respectively. A blinded comparison of TCE and endoscopic BE measurements showed a strong to very strong correlation (r = 0.7-0.83; p<0.05) for circumferential extent and a strong correlation (r=0.77-0.78; p< 0.01) for maximum extent (Prague classification). TCE interobserver correlation was very strong, r=0.92 and r=0.84 (p<0.01), for C and M measurements, respectively.ConclusionsTCE is a safe and feasible procedure for obtaining high-resolution microscopic images of the upper GI tract without endoscopic assistance or sedation.
Computerized feedback during colonoscopy training leads to improved performance: a randomized trial Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-19 Andreas Slot Vilmann, David Norsk, Morten Bo Søndergaard Svendsen, Rasmus Reinhold, Lars Bo Svendsen, Yoon Soo Park, Lars Konge
Background and AimsSimulation-based training in colonoscopy is increasingly replacing the traditional apprenticeship method to avoid patient-related risk. Mentoring during simulation is necessary to provide feedback and to motivate, but expert supervisors are a scarce resource. We aimed to determine whether computerized feedback in simulated colonoscopy would improve performance, optimize time spent practicing, and optimize the pattern of training.MethodsForty-four participants were recruited and randomized to either a feedback group (FG) or a control group (CG). Participants were allowed 2 hours of self-practice where they could practice as they saw fit on 2 different cases: one easy and one difficult. The CG practiced without feedback but the FG was given a score of progression every time they reached the cecum. All participants were tested on a different case after end of training. The primary outcome was progression score in the final case and secondary outcomes were time spent practicing and training pattern.ResultsRegression analysis adjusting for sex was done due to an uneven sex distribution between groups (P = 0.026) and significantly higher performance scores by men (37.6, SD 25.9) compared with women (19.7, SD 18.7), P = 0.012. The FG outperformed the CG in the final case (FG scoring 14.4 points (95% CI, 1.2 - 27.6) more than the CG, P = 0.033) and spent more time practicing (FG practicing 25.8 minutes [95% CI, 11.6 - 39.9] more than the CG; P = 0.001). The FG practiced more on the easy case and reached the cecum 3.2 times more (95% CI, 2 - 4.5) during practice (P < 0.001).ConclusionsOur findings of this study revealed that an automatic, computerized score of progression during simulated colonoscopy motivates the novices to improve performance, optimize time spent practicing, and optimize their pattern of training (Clinical trial registration number: NCT03248453).
Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-18 R.C. Bell, J.C. Lipham, B.E. Louie, V.A. Williams, J.D. Luketich, M.A. Hill, W.O. Richards, C.M. Dunst, D.G. Lister, L.E. McDowell-Jacobs, P.R. Reardon, K.L. Woods, J.C. Gould, F. Buckley, S.N. Kothari, L. Khaitan, C.D. Smith, A. Park, P.O. Katz
Background and Aims GERD patients frequently complain of regurgitation of gastric contents. Medical therapy with proton-pump inhibitors (PPIs) is frequently ineffective in alleviating regurgitation symptoms, as PPIs do nothing to restore a weak lower esophageal sphincter. Our aim was to compare effectiveness of increased PPI dosing with laparoscopic magnetic sphincter augmentation (MSA) in patients with moderate-to-severe regurgitation despite once-daily PPI therapy. Methods One hundred fifty-two GERD patients >21 years with moderate-to-severe regurgitation despite 8weeks of once-daily PPI therapy were prospectively enrolled at 21 U.S. sites. Participants were randomized 2:1 to treatment with twice-daily (BID) PPIs (N=102) or to laparoscopic MSA (N=50). Standardized foregut symptom questionnaires and ambulatory esophageal reflux monitoring were performed at baseline and at 6 months. Relief of regurgitation, improvement in foregut questionnaire scores, decrease in esophageal acid exposure and reflux events, discontinuation of PPIs, and adverse events were the measures of efficacy. Results Per protocol, 89% (42/47) of treated MSA patients reported relief of regurgitation compared with 10% (10/101) of the BID PPI group (p<0.001) at the 6-month primary endpoint. By ITT analysis, 84% (42/50) of MSA and 10% (10/102) of BID PPI patients met this primary endpoint (p<0.001)). Eighty-one percent (38/47) of MSA patients versus 8% (7/87) of BID PPI patients had >50% improvement in GERD-HRQL score (p<0.001); and 92% (4/47) remained off PPI. A normal number of reflux episodes and acid exposure was observed in 91% (40/44) and 89% (39/44) of MSA patients, respectively, compared with 58% (46/79) (p<0.001) and 75% (59/79) (p=0.065) of BID PPI patients at 6 months. No significant safety issues were observed; in MSA patients 28% reported transient dysphagia, ongoing 4%. Conclusions GERD patients with moderate-to-severe regurgitation, especially despite once-daily PPI treatment, should be considered for minimally invasive treatment with magnetic sphincter augmentation rather than increased PPI dosing. Trial Registration ClinicalTrials.gov, identifier: NCT02505945.
Efficacy and safety of endobiliary radiofrequency ablation for the eradication of residual neoplasia after endoscopic papillectomy: a multicenter prospective study Gastrointest. Endosc. (IF 7.204) 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 AimsEndobiliary dysplasia may persist after endoscopic papillectomy. Intraductal radiofrequency ablation (ID-RFA) is a potential alternative to complementary surgery. The aim of this study was to evaluate the efficacy and safety of ID-RFA for the treatment of adenomatous intraductal residue after endoscopic papillectomy.MethodsA 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 W, 30 seconds) 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.ResultsTwenty patients (67 ± 11 years of age, 12 men) were included. The endobiliary adenoma was in LGD in 15 patients and HGD in 5 patients. All underwent 1 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 = .01).ConclusionsID-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. (Clinical trial registration number: NCT02825524.)
Water-pocket endoscopic submucosal dissection for superficial gastric neoplasms (with video) Gastrointest. Endosc. (IF 7.204) 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 AimsDuring 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 (WP) that provides a clear view in the dissection field. Therefore, we aimed to investigate the feasibility and safety of WP-ESD for superficial gastric neoplasms.MethodsWe 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.ResultsTotal procedure time was significantly shorter in the WP-ESD group than in the S-ESD group (median [interquartile range], 27.5 [19-45] minutes vs 41 [29.8-69] minutes; P < .001). Similarly, the dissection speed was significantly greater in the WP-ESD group than in the S-ESD group (median [interquartile range], 22.5 [16.8-35.3] mm2/min vs 17.3 [12.7-22.1] mm2/min; P < .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 > .99). There were no perforations in either group.ConclusionWP-ESD was associated with a shorter procedure time than S-ESD. WP-ESD may provide an alternative method for resection of superficial gastric neoplasms. (Clinical trial registration number: UMIN 000030266.)
Impact of fellowship training level on colonoscopy quality and efficiency metrics Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-04-19 Hussein Bitar, Hassaan Zia, Muhammad Bashir, Pratyusha Parava, Muhammad Hanafi, William Tierney, Mohammad Madhoun
Background and AimsPrevious 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.MethodsWe performed a retrospective review of 2024 patients (mean age, 60.9 ± 10 years; 94% men) 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 1 group each. We collected data on doses of sedatives used, frequency of adjunctive agent use, procedural times, and location, size, and histology of polyps. We defined the adenoma management efficiency index as average time required per adenoma resected during withdrawal.ResultsOf the colonoscopies performed, 1675 involved a fellow and 349 were performed by the attending alone. There was no difference in ADR between fellows according to level of training (P = .8) or between fellows compared with attending-only procedures (P = .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 < .001). There was no difference in the average doses of midazolam and fentanyl used among fellow groups (P = .16 and P = .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 < .0001, P = .0002, P < .0001, and P = .01, respectively).ConclusionsADR 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 the attending level. Fellow involvement led to a greater use of moderate sedation, which may relate to a longer procedure duration and an evolving experience in endoscopic technique.
Newly developed endoscopic detachable snare ligation therapy for colonic diverticular hemorrhage: a multicenter phase II trial (with videos) Gastrointest. Endosc. (IF 7.204) 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 AimsWe 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.MethodsThis 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.ResultsFrom June 2015 to March 2017, bleeding diverticula were detected in 123 of 205 enrolled patients (60%), of whom 101 (82%) were treated with EDSL. Most patients (20/22) in whom EDSL was not successful were treated with clipping. The early recurrent bleeding rate was 7.9% (95% confidence interval, 2.6%-13.2%; 8/101) in patients who could be treated with EDSL. The median total endoscopic and EDSL procedure time was 40 minutes (interquartile range, 15-71) and 4 minutes (interquartile range, 1-7), respectively. Two mild adverse events, colonic diverticulitis and temporary abdominal pain, were observed.ConclusionEDSL was confirmed to be useful and safe for treatment of colonic diverticular hemorrhage. (Clinical trial registration number: UMIN 000001858.)
Duodenoscope reprocessing practice patterns in U.S. endoscopy centers: a survey study Gastrointest. Endosc. (IF 7.204) 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 AimsAfter recent outbreaks of duodenoscope-related infections from multidrug-resistant organisms (MDRO), the United States Food and Drug Administration (FDA) recommended implementing 1 or more of 4 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.MethodsPhysicians, 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.ResultsA 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.ConclusionsAlthough most 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.
Valuing innovative endoscopic techniques: per-oral endoscopic myotomy for the management of achalasia Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-04-21 Eric D. Shah, Andrew C. Chang, Ryan Law
Background and AimsUnclear 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.MethodsWe 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.ResultsEffectiveness 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.ConclusionPOEM 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.
Use of diphenhydramine as an adjunctive sedative for colonoscopy in patients on chronic opioid therapy: a randomized controlled trial Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-04-22 Salman Nusrat, Mohammed F. Madhoun, William M. Tierney
Background and AimsChronic 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.MethodsThis randomized, double-blind, placebo-controlled trial included patients on chronic opioids undergoing colonoscopy. Patients were randomized to receive 50 mg of diphenhydramine intravenously (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.ResultsThere was no difference in amounts of fentanyl (125.4 ± 56.2 μg vs 126.9 ± 53.5 μg, P = .88) and midazolam (4.9 ± 2.1 mg vs 5 ± 1.9 mg, P = .79) used. The mean sedation scores from the physician (6.2 ± 1.1 vs 5.3 ± 1.2, P =.0002) and nurses (5.6 ± 1.5 vs 5.1 ± 1.4, P =.04) were statistically significant in favor of the diphenhydramine arm. Patient scores for pain (2.05 ± 2.17 vs 3.09 ± 3.95, P =.047) and amnesia (7.8 ± 3.4 vs 6.5 ± 3.8, P =.047) favored the group that received diphenhydramine. Qualitative assessment showed no significant difference between the groups. There was no difference in induction time (P = .86), procedure duration (P = .98), or recovery time (P = .16). Hypotensive episodes were more common in the placebo group (P = .027).ConclusionsIn 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. (Clinical trial registration number: NCT T01967433.)
The impact of chromoendoscopy for surveillance of the duodenum in patients with MUTYH-associated polyposis and familial adenomatous polyposis Gastrointest. Endosc. (IF 7.204) 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 AimsDuodenal 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, and 5% will develop 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.MethodsA 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.ResultsEnhanced adenoma detection of 3 times the number of adenomas after chromoendoscopy was demonstrated in both MAP (P = .013) and FAP (P = .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.ConclusionsChromoendoscopy improved the diagnostic yield of anomas 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.
Transplantation of autologous esophageal mucosa to prevent stricture after circumferential endoscopic submucosal dissection of early esophageal cancer (with video) Gastrointest. Endosc. (IF 7.204) 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
Background and AimsEsophageal stricture is a common adverse event after endoscopic submucosal dissection (ESD) when it involves the entire circumference of the esophagus. We aimed to assess the effectiveness and safety of endoscopic transplantation of autologous esophageal mucosa in preventing stricture formation after circumferential ESD.MethodsNine patients who underwent circumferential ESD for early esophageal cancer were enrolled. After the patients underwent ESD, autologous esophageal mucosal patches were attached to the ulcer surface by using hemoclips and were 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.ResultsEpithelialization 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 days) after the procedure. The median number of endoscopic balloon dilatation sessions was 2.7 (range 0-6).ConclusionsTransplantation of autologous esophageal mucosa could be a safe way of relieving the severity of esophageal stricture after circumferential ESD.
Clinical efficacy of anti-migration features in fully covered self-expandable metallic stents for anastomotic biliary strictures after liver transplantation: comparison of standard and anti-migration stents Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-10 Benoit Bordaçahar, Fabiano Perdigao, Sarah Leblanc, Maximilien Barret, Jean-Christophe Duchmann, Marie Anne Guillaumot, Stanislas Chaussade, Olivier Scatton, Frédéric Prat
Background and Aims Anastomotic biliary strictures (ABSs) are one of the most frequent adverse events that occur after orthotopic liver transplantation (OLT). Multiple plastic stents (MPSs) have been validated for this indication. More recently, fully covered self-expandable metallic stents (FCSEMSs) have been used with positive outcomes, but also have a higher rate of migration, which may limit success. Our primary objective was to compare stent migration rates observed with “standard” FCSEMSs (Std-FCSEMSs) and so-called “anti-migration” FCSEMSs (Am-FCSEMSs), which are newly designed with reversed proximal side flaps. Secondary objectives were to compare rates of stricture resolution and procedure-related morbidity. Methods We conducted a retrospective analysis of a subset of patients (FCSEMSs for post-OLT ABS) from 2 prospectively maintained databases of (1) OLT patients, and (2) ERCP and stent placement. Between January 2009 and January 2016, consecutive patients presenting with ABS after OLT referred to Cochin Hospital (Paris, France) for ERCP and receiving a FCSEMS were included. Exclusion criteria were any other cause of biliary stricture (ie, malignant stricture, ischaemic origin), and biliary fistulae. Results One hundred twenty-five FCSEMSs (57 Am-FCSEMSs, 52 type 1 Std-FCSEMSs, and 16 type 2 Std-FCSEMSs) were used in 75 patients for ABS after OLT, with a planned stent placement period of 6 months in all patients. Patient characteristics and rates of previous endoscopic treatment or timing of ABS occurrence after OLT were not different between groups. The rate of FCSEMS complete migration was 16% (20/125), consisting of 1.7% (1/57) for Am-FCSEMSs and 28% (19/68) for type 1 and 2 Std-FCSEMSs (p<0.0001). All attempted stent removals (100% of patients) were successful. First follow-up ERCP after each FCSEMS highlighted a stricture resolution rate of 78.4% (98/125), including 93% (53/57) for Am-FCSEMSs and 66.2% (45/68) for type 1 and 2 Std-FCSEMSs (p<0.001). After a median follow-up of 28 months after stent removal (12-66), stricture recurrence was observed in 12.3% [11-17] of patients treated with Am-FCSEMSs against 55.9% [54-56] of those receiving Std-FCSEMSs (p<0.0001). Conclusions In patients with ABS after OLT, the use of Am-FCSEMSs significantly decreased the risk of stent migration, improved stricture resolution at the time of stent removal and reduced the rate of stricture recurrence during follow-up. Endoscopic removal success and procedure-related morbidity were similar for both standard and anti-migration stents.
A neural network algorithm for detection of GI angiectasia during small-bowel capsule endoscopy Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-11 Romain Leenhardt, Pauline Vasseur, Cynthia Li, Jean Christophe Saurin, Gabriel Rahmi, Franck Cholet, Aymeric Becq, Philippe Marteau, Aymeric Histace, Xavier Dray,
Background and Aims Gastrointestinal angiectasia (GIA) is the most common small-bowel (SB) vascular lesion, with an inherent risk of bleeding. SB capsule endoscopy (SB-CE) is the currently accepted diagnostic procedure. The aim of this study was to develop a computer-assisted diagnosis (CAD) tool for the detection of GIA. Methods Deidentified SB-CE still frames featuring annotated typical GIA and normal control still frames, were selected from a database. A semantic segmentation images approach associated with a convolutional neural network (CNN) was used for deep feature extractions and classification. Two datasets of still frames were created and used for machine learning and for algorithm testing. Results The GIA detection algorithm yielded a sensitivity of 100%, a specificity of 96%, a positive predictive value of 96%, and a negative predictive value of 100%. Reproducibility was optimal. The reading process for an entire SB-CE video would take 39 minutes. Conclusion The developed CNN-based algorithm had high diagnostic performances allowing detection of GIA in SB-CE still frames. This study paves the way for future automated CNN-based SB-CE reading softwares.
Impact of magnetic steering on gastric transit time of a capsule endoscopy (with video) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-11 Xi Jiang, Yang-Yang Qian, Xiao Liu, Jun Pan, Wen-Bin Zou, Wei Zhou, Yuan-Yuan Luo, Yi-Zhi Chen, Zhao-Shen Li, Zhuan Liao
Backgrounds and Aims Delayed gastric transit of the capsule may lead to incomplete small bowel examination, reducing the diagnostic yield. Thus this study was designed to determine if magnetic steering could enhance capsule gastric emptying and mucosal visualization within the duodenum. Methods The intervention group comprised 100 patients undergoing magnetic-controlled capsule endoscopy (MCE) between May to September 2017 in whom magnetic control was used to assist transpyloric passage of the capsule and duodenal inspection. A cohort of 100 patients who had undergone the procedure before May 2017 was randomly selected from the database as a historic control group in whom transpyloric movement of the capsule occurred spontaneously (without magnetic assistance). The difference in the pyloric transit time (PTT) and duodenal papilla detection rate (DPDR) between the 2 groups were compared, and related factors were also investigated. Results Transpyloric passage of the capsule under magnetic control was successfully performed in 59 (59%) patients. Median PTT was greatly reduced in the intervention group from 58.38 minutes (13.45-87.47) to 4.69 minutes (1.56-55.00) (P<0.001), and DPDR was also greatly improved with magnetic steering (30.5% vs 9%, P<0.001). Magnetic steering, male gender, and higher BMI were independently associated with reduced gastric transit time and magnetic steering with an enhanced DPDR. Conclusions Magnetic steering of the capsule can enhance gastric emptying of the capsule and may prove useful in non-obese and female patients who appeared to have longer GTTs, and achieved a better DPDR than that under the action of peristalsis alone. Trial registration ClinicalTrials.gov, ID: NCT03441945
Etiological spectrum and response to endoscopic balloon dilation in patients with benign gastric outlet obstruction Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-11 Rakesh Kochhar, Sarthak Malik, Pankaj Gupta, Yalaka rami Reddy, Narendra Dhaka, Saroj Kant Sinha, Vikas Gupta, Mohd Talha Noor, Bipadabhanjan Mallick
Background and aims Peptic ulcer disease (PUD)-related gastric outlet obstruction (GOO) is known to respond favorably to endoscopic balloon dilation (EBD). However, data on efficacy of EBD for other etiologies of benign GOO is sparse. We aimed to compare response of EBD among different etiologies of GOO. Methods Records of all patients with benign GOO who underwent EBD at our tertiary care center between January 1998 to December 2017 were analyzed. Dilation was done using through-the-scope balloons. Procedural and clinical success of EBD was compared among different etiologies. Results A total of 306 patients were evaluated, of whom, 264 (mean age - 37.89 + 17.49; males - 183, females - 81) underwent dilation. Etiologically caustic ingestion was the commonest cause of GOO (53.8%) followed by PUD (26.1%) and medication-induced (8.3%). Overall procedural and clinical success was achieved in 200 (75.7%) and 243 (92.04%) patients respectively requiring a mean (SD) of 2.55 (2.8) and 5.37 (3.9) sessions respectively. Caustic-induced GOO responded less favorably, requiring a higher number of dilation sessions and having more refractory strictures than other etiologies. Medication-induced GOO performed worse than PUD-related GOO. Of the 264 patients, 9 (3.4%) had perforation during EBD, 3 of them had a contained leak and were managed conservatively, whereas 6 patients underwent successful surgery. Conclusion EBD is successful in a majority of patients with benign GOO, with caustic-induced GOO and medication-induced GOO being more difficult than PUD-related GOO
Water exchange colonoscopy increases adenoma detection rate: a systematic review with network meta-analysis of randomized controlled studies Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-05 Lorenzo Fuccio, Leonardo Frazzoni, Cesare Hassan, Marina La Marca, Valentina Paci, Veronica Smania, Nicola De Bortoli, Franco Bazzoli, Alessandro Repici, Douglas Rex, Sergio Cadoni
Background and AimsWater-aided colonoscopy techniques (water immersion, WI; water exchange, WE) have shown different results regarding adenoma detection rate (ADR). We determined the impact of WI and WE on ADR and other procedural outcomes versus gas (air, AI; carbon dioxide, CO2) insufflation colonoscopy.MethodsSystematic search of multiple databases for randomized controlled trials comparing WI and/or WE with AI and/or CO2 and reporting ADR. A network meta-analysis with mixed comparisons was performed. Primary outcome was ADR (overall, in the right side of the colon and by colonoscopy indication).ResultsSeventeen randomized controlled trials (10,350 patients) were included. WE showed a significantly higher overall ADR versus WI (odds ratio [OR], 1.31; 95% credible interval [CrI], 1.12–1.55), versus AI (OR, 1.40; CrI, 1.22–1.62)], versus CO2 (OR, 1.48; 95% CrI, 1.15–1.86). WE achieved the highest ADR also in the right side of the colon and in colorectal cancer screening cases (both significant vs AI and WI), as wells as in patients taking a split-dose preparation (significant vs all the other techniques). Boston Bowel Preparation Scale cleanliness score (vs AI and WI) were significantly higher for WE. Both WI and WE showed increased proportion of unsedated examinations and decreased real-time insertion pain, with WE being the least-painful insertion technique. Withdrawal time was comparable across techniques, but WE showed the longest insertion time (3-5 additional minutes).ConclusionsWater exchange significantly increases overall ADR, ADR in screening cases and the right side of the colon ADR; it also improves colon cleanliness but requires a longer insertion time.
Managing underperformance in endoscopy: a pragmatic approach Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-06 Colin J. Rees, Siwan Thomas-Gibson, Michael J. Bourke, Douglas Rex, Paul Fockens, Michal F. Kaminski, Neil Haslam, Martin Walls
GI endoscopy is increasingly the procedure of choice for the investigation and management of upper and lower GI symptoms. Internationally, key performance indicators (KPIs) are often used to provide key data points and auditable outcomes for endoscopists and endoscopy services with published standards existing for colonoscopy, bowel cancer screening, flexible sigmoidoscopy, ERCP and upper GI endoscopy. Quality assurance (QA) and training programs aim to ensure high skill levels of endoscopists and, supported by quality improvement programs (QI), aim to raise the quality of endoscopy service provision. There are currently few defined processes to guide services where standards are not being met. This document, written by a group of international endoscopy experts, is intended to provide pragmatic guidance to units or programs for managing performance that falls below the desired level. The guidance has been written generically with principals applicable to all endoscopic techniques.
The association among diet, dietary fiber, and bowel preparation at colonoscopy Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-06 Anna M. Leszczynski, Kristin L. MacArthur, Kerrie P. Nelson, Samuel A. Schueler, Paula A. Quatromoni, Brian C. Jacobson
Background and AimsPre-colonoscopy dietary restrictions vary widely and lack evidence-based guidance. We investigated whether fiber and various other foods/macronutrients consumed during the 3 days before colonoscopy are associated with bowel preparation quality.MethodsThis was a prospective observational study among patients scheduled for outpatient colonoscopy. Subjects received instructions including split-dose polyethylene glycol, avoidance of vegetables/beans two days before colonoscopy and clear liquid diet the day before colonoscopy. Two 24-hour dietary recall interviews and one patient recorded food log measured dietary intake on the 3 days before colonoscopy. The Nutrition Data System for Research was used to estimate dietary exposures. Our primary outcome was the quality of bowel preparation measured by the Boston Bowel Preparation Scale (BBPS).ResultsWe enrolled 201 subjects from November 2015 to September 2016 with complete data for 168. The mean age was 59 (SD 7) and 90% of colonoscopies were conducted for screening/surveillance. Only 17% and 77% of subjects complied with diet restrictions 2 and 1 day(s) before colonoscopy, respectively. We found no association between foods consumed 2 and 3 days before colonoscopy and BBPS scores. However, BPPS was positively associated with intake of gelatin, and inversely associated with intake of red meat, poultry, and vegetables on the day before colonoscopy.ConclusionsOur findings support recent guidelines encouraging unrestricted diets >1 day before colonoscopy if using a split-dose bowel regimen. Furthermore, we found no evidence to restrict dietary fiber one day before colonoscopy. We also found evidence to promote consumption of gelatin and avoidance of red meat, poultry, and vegetables one day before colonoscopy.
A prospective multicenter study using a new multiband mucosectomy device for endoscopic resection of early neoplasia in Barrett’s esophagus Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-06 Roos E. Pouw, Torsten Beyna, Kamar Belghazi, Arjun D. Koch, Erik J. Schoon, Rehan Haidry, Bas L. Weusten, Raf Bisschops, Nicholas J. Shaheen, Michael B. Wallace, Norman Marcon, Rachel Heise-Ginsburg, Anniek W. Gotink, Kenneth K. Wang, Cadman L. Leggett, Jacobo Ortiz-Fernández-Sordo, Krish Ragunath, Massimiliano DiPietro, Jacques J. Bergman
Background and AimsEarly neoplasia in Barrett’s esophagus (BE) can be effectively and safely removed by endoscopic resection (ER) using multi-band mucosectomy (MBM). This study aimed to document performance of a novel MBM device designed for improved visualization, easier passage of accessories, and better suction power compared with other marketed MBM devices.MethodsThis international single-arm, prospective registry in 14 referral centers (Europe 10, United States 3, Canada 1), included patients with early BE neoplasia scheduled for ER. Primary endpoint was successful ER defined as complete resection of the delineated area in one procedure. Secondary outcomes were adverse events and procedure time.ResultsA total of 332 lesions was included, in 291 patients (248 men, mean age 67 years (SD 9.6)). ER indication was high-grade dysplasia in 64%, early adenocarcinoma in 19%, lesion with low-grade dysplasia in 11%, and a lesion without definite histology in 6%. Successful ER was reached in 322 out of 332 (97%; 95% CI, 94.6%-98.4%) lesions. A perforation occurred in 3 out of 332 procedures (0.9%; 95% CI, 0.31%-2.62%), all were managed endoscopically and patients were admitted with intravenous antibiotics during 2, 3, and 9 days. Postprocedural bleeding requiring an intervention occurred in 5 out of 332 resections (1.5%; 95% CI, 0.65% – 3.48%). Dysphagia requiring dilatation occurred in 11 patients (3.8%; 95% CI, 2.1%-6.6%). Median procedure time was 16 minutes (IQR 12.0-26.0).ConclusionsIn expert hands, the novel MBM device proved to be effective for resection of early neoplastic lesions in BE, with successful ER in 97% of procedures. Severe adverse events were rare and were effectively managed endoscopically or conservatively.
Technical feasibility of endoscopic submucosal dissection for local failure after chemoradiotherapy or radiotherapy for esophageal squamous cell carcinoma Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-06 Keiichiro Nakajo, Yusuke Yoda, Keisuke Hori, Kenji Takashima, Kensuke Sinmura, Yasuhiro Oono, Hiroaki Ikematsu, Tomonori Yano
Background and AimsSalvage endoscopic submucosal dissection (ESD) after chemoradiotherapy might be technically difficult due to radiation-induced fibrosis. We aimed to evaluate the technical feasibility of ESD for local failure after chemoradiotherapy for esophageal squamous cell carcinoma (ESCC), and for other primary lesions within the irradiation field.MethodsConsecutive patients treated with ESD for superficial ESCC between December 2009 and May 2017 were retrospectively investigated and stratified into group A (33 patients, 35 lesions; local failure at the primary site after chemoradiotherapy), group B (25 patients, 34 lesions; second primary lesions within the irradiation field), and group C (550 patients, 596 lesions; radiotherapy-naïve superficial ESCC). We evaluated procedural success rate, en bloc resection rate, 1-year local relapse-free survival (LRFS) rate, procedure time, and incidence of major adverse events.ResultsThe rates of procedural success and en bloc resection, respectively, were significantly lower in group A (89%, 86%) than in groups B (100%, 100%) and C (100%, 98%). The 1-year LRFS rates were 86%, 100%, and 99% in groups A, B, and C, respectively, and significantly lower in group A than in group C. Although serious adverse events including perforation were not observed in groups A and B; perforation occurred only in group C (2.8%).ConclusionsESD is technically feasible in patients with local failure, especially as initial salvage treatment and as treatment for second primary lesions within the irradiation field.
Preoperative EUS-guided fine-needle aspiration: effects on peritoneal recurrence and survival in patients with pancreatic cancer Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-04 Sun Hwa Kim, Young Sik Woo, Kwang Hyuck Lee, Jong Kyun Lee, Kyu Taek Lee, Joo Kyung Park, Soo Hoon Kang, Ji Won Kim, Jae Keun Park, Sung Wook Park
Background and AimsEndoscopic ultrasound-guided fine-needle aspiration (EUS-guided FNA) is an accurate and relatively safe tissue confirmation method for pancreatic cancer. However, there is concern that this procedure may spread tumor cells along the needle track or within the peritoneum. We aimed to estimate the effect of preoperative EUS-guided FNA on the risk of peritoneal recurrence and long-term outcomes in resected pancreatic cancer.MethodsWe retrospectively reviewed records of patients diagnosed with pancreatic cancer who had undergone curative resection between 2009 and 2013 to investigate the overall survival, cancer-free survival, and peritoneal recurrence. Peritoneal recurrence was diagnosed based on image findings or cytology-confirmed ascites.ResultsOf 411 patients, 90 underwent preoperative EUS-guided FNA (EUS-FNA group) whereas 321 did not (non-EUS-FNA group). The median length of follow-up was 16.2 months (range, 2 to 46 months). Peritoneal recurrence occurred in 131 patients: 30% (27/90) in the EUS-FNA group versus 32% (104/321) in the non-EUS-FNA group (P = .66). Cancer-free survival or overall survival was not significantly different between the 2 groups: median overall survival of 25.3 months in the EUS-FNA group versus 23.7 months in the non-EUS-FNA group (P = .36); median cancer free survival of 12.7 months in the EUS-FNA group versus 11.6 months in the non-EUS-FNA group (P = .38).ConclusionsPreoperative EUS-guided FNA for pancreatic cancer was not associated with an increased rate of peritoneal recurrence or mortality. Therefore, EUS-guided FNA is an accurate and safe method to obtain suspicious pancreatic mass tissue.
Successful liver-directed gene delivery by ERCP-guided hydrodynamic injection (with videos) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-07-03 Vivek Kumbhari, Ling Li, Klaus Piontek, Masaharu Ishida, Rongdang Fu, Bassem Khalil, Caroline M. Garrett, Eleni Liapi, Anthony N. Kalloo, Florin M. Selaru
Background and Aims A simple, safe, targeted and efficient in vivo DNA delivery system is necessary for clinical-grade liver targeted gene therapy in humans. Intravascular hydrodynamic gene delivery has been investigated in large animal models but translation to humans has been hampered by its technical challenges, invasiveness and potential for significant cardiovascular adverse events. We posited that intrabiliary delivery of DNA plasmids via ERCP-guided hydrodynamic injection overcomes these obstacles. Methods Twelve pigs (40-50 kg) were divided into 3 groups (n=4 per group) and survived 21, 30, or 60 days. ERCP was performed by inflating a balloon catheter in the common hepatic duct and creating a closed space between it and the liver parenchyma. Last, a solution composed of plasmid/sleeping beauty (SB) mix was injected under pressure through the catheter into the closed space. Swine were killed at the 3 different time points and liver tissue harvested. Plasmid DNA expression and functional translated protein expression were assessed. Results ERCP-guided hydrodynamic delivery of naked plasmid DNA facilitated by pCMV-Sleeping Beauty transposons was technically feasible and devoid of cardiovascular and local adverse events in all 12 pigs. Furthermore, plasmid DNA (both single and combination) was successfully transferred into swine hepatocytes in all 12 pigs. Additionally, stable integration of the DNA constructs in hepatocyte genomic DNA were reliably noted at all 3 time points. In the 4 swine that were kept alive to 60 days, successful genomic integration and subsequent protein expression was observed in the targeted liver tissue. Conclusions ERCP-guided hydrodynamic delivery of gene therapy may usher in the next chapter in gene therapy with the potential to impact a variety of single-gene, complex genetic and epigenetic liver diseases. It also raises the possibility that other nucleic acid therapeutics (microRNA, lncRNA, siRNA, shRNA) could similarly be delivered.; Acronyms: inferior vena cava (IVC); endoscopic retrograde cholangiopancreatography (ERCP); common hepatic duct (CHD); common bile duct (CBD); tiletamine, zolazepam, ketamine, and xylazine (TKX)
Low-grade dysplasia diagnosis ratio and progression metrics identify variable Barrett’s esophagus risk stratification proficiency in independent pathology practices Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-06-23 Jon M. Davison, Maulin B. Shah, Christopher Deitrick, Jennifer Chennat, Ken E. Fasanella, Kevin McGrath
Background and Aims The diagnosis of low-grade dysplasia (LGD) in Barrett’s esophagus (BE) is subject to substantial interobserver variation. Our central aim in this study is to compare independent pathology practices using objective measures of BE risk stratification proficiency, including frequency of diagnosis and rate of progression to high-grade dysplasia (HGD) or adenocarcinoma (EAC) after the first diagnosis of LGD. Methods We retrospectively evaluated over 29,000 endoscopic biopsy cases to identify 4734 patients under endoscopic biopsy surveillance for BE in a health care system with multiple independent pathology practices: a subspecialized GI pathology group (SSGI; 162 BE cases per pathologist annually), 3 high BE volume general surgical pathology practices (GSPs; >50 BE cases per pathologist annually) and multiple low BE volume GSPs (10.6 BE cases per pathologist annually). We measured LGD diagnosis frequencies and rates of diagnostic progression to HGD or EAC in patients diagnosed with LGD. Results The proportion of all BE cases diagnosed as LGD (LGD/BE diagnosis ratio) ranged from 1.1% to 6.8% in the different hospital settings (P<0.001). The cumulative proportion of patients with HGD or EAC within 2 years of the first diagnosis of LGD was 35.3% in the SSGI and ranged from 1.4% to 14.3% in the GSPs (P<0.001). LGD diagnosed by the GSP with the lowest LGD/BE diagnosis ratio had an adjusted risk of progression similar to LGD diagnosed by subspecialists (hazard ratio, 0.42; 95% CI, 0.06-3.03). However, when LGD was diagnosed by other generalists, the adjusted risk of progression was 79-91% lower than subspecialists (P<0.001). When LGD was diagnosed in a low volume GSP practice, the risk of progression was not significantly increased relative to patients with nondysplastic BE (hazard ratio, 1.3; 95% CI, 0.4-3.9). Conclusions General surgical pathologists and subspecialists show highly significant differences with respect to LGD/BE ratio, risk of progression relative to nondysplastic BE, crude annual progression rates, and the cumulative 2-year progression rate after LGD. These metrics can be used to assess proficiency in BE risk stratification in historical cases. Some general practitioners were able to achieve results similar to subspecialists. General surgical pathologists with little annual experience evaluating BE biopsies did not successfully risk-stratify patients with BE.
Focal cryoballoon versus radiofrequency ablation of dysplastic Barrett's esophagus: impact on treatment response and postprocedural pain Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-06-19 Sanne N. van Munster, Anouk Overwater, Rehan Haidry, Raf Bisschops, Jacques J.G.H.M. Bergman, Bas L.A.M. Weusten
Background and aims Radiofrequency ablation (RFA) is safe and effective for eradicating Barrett’s esophagus (BE), but associated with significant postprocedural pain. Alternatively, balloon-based focal cryoablation (CRYO) has recently been developed, which preserves the extracellular matrix and might therefore be less painful. Although data for CRYO are still limited, uncontrolled studies suggest comparable safety and efficacy to RFA in eradicating limited BE areas. Therefore, secondary endpoints such as pain might become decisive for treatment selection. We aimed to compare efficacy and tolerability between focal CRYO and RFA. Methods We identified BE patients undergoing focal ablation (either RFA or CRYO) of all visible BE, from our prospective cohort in 2 Dutch referral centers. After ablation, patients completed a 14-day digital diary to assess chest pain (0-10), dysphagia (0-4) and analgesics use. A follow-up (FU) endoscopy was scheduled after 3 months to assess the BE surface regression (blindly scored by 2 independent BE expert endoscopists). Outcomes were BE surface regression; 14-days cumulative scores (area-under-the-curves (AUCs)) for pain, dysphagia, analgesics, and peak pain. Results We identified 46 patients (20 CRYO, 26 RFA) with similar baseline characteristics. The BE regression was comparable (88% versus 90%, p 0.62). AUCs for pain, dysphagia and analgesics were significantly smaller after CRYO versus RFA (all p<0.01). Peak pain was lower after CRYO (VAS 2 versus 4, P<0.01) and the duration of pain was also shorter after CRYO (2 versus 4 days, p<0.01). CRYO patients used analgesics for 2 days versus 4 for RFA (p<0.01). Conclusions In this multicenter, nonrandomized cohort study, we found no differences in efficacy after a single treatment with CRYO and RFA for short-segment BE. Patients reported less pain after CRYO as compared with RFA. Moreover, CRYO patients used fewer analgesics. Our results suggest a different pain course favoring CRYO over RFA, but a randomized trial is needed for definitive conclusions.
A randomized controlled trial comparing efficacy of early video capsule endoscopy with standard of care in the approach to non-hematemesis gastrointestinal bleeding (with videos) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-06-20 Neil B. Marya, Salmaan Jawaid, Anne Foley, Samuel Han, Krunal Patel, Louise Maranda, Daniel Kaufman, Kanishka Bhattacharya, Christopher Marshall, Joseph Tennyson, David R. Cave
Objective Patients presenting with non-hematemesis GI bleeding represent a diagnostic challenge for physicians. We performed a randomized controlled trial to assess the benefits of deployment of a video capsule soon after admission in the management of patients presenting with melena, hematochezia, or severe anemia compared with standard of care management. Design: Patients admitted with non-hematemesis GI bleeding were randomized and placed into one of 2 study groups. In the experimental group patients ingested a video capsule soon after admission to the hospital. These capsule patients had further endoscopic workup based on the findings from the capsule. Patients in the control group underwent endoscopic evaluation (ie, upper endoscopy, capsule endoscopy, and/or colonoscopy) to identify the source of bleeding as directed by the attending gastroenterologist’s interpretation of their clinical presentation. The primary endpoint for this study was the rate of localization of bleeding during hospitalization. Results Eighty-seven patients were included in this study, 45 were randomized to the Standard of Care arm and 42 were randomized to the Early Capsule arm. A bleeding source was localized in 64.3% of the patients in the Early Capsule arm and in 31.1% of the patients in the Standard of Care arm (p < 0.01). The likelihood of endoscopic localization of bleeding over time was greater for patients receiving early capsule endoscopy compared with those in the standard of care arm (adjusted hazard ratio, 2.77; 95% confidence interval, 1.36 – 5.64). Conclusion For patients admitted to the hospital for non-hematemesis GI bleeding, early capsule endoscopy is a safe and effective alternative for the detection of the source of bleeding.
How we resect colorectal polyps <20 mm in size Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-06-15 Douglas K. Rex, Evelien Dekker
We review our approach to resection of colorectal polyps <20 mm in size. Careful inspection of all lesions is appropriate to assess the type of lesion (adenoma vs serrated) and evaluate the risk of cancer, which is highly associated with lesion size. Polyp resection is in the midst of a “cold revolution,” particularly for lesions <10 mm in size, but also for some larger lesions. Cold forceps are sometimes appropriate for 1- to 2-mm lesions that can be engulfed in one bite, but we use cold snaring for almost the entire set of lesions <10 mm. For 10- to 19-mm conventional adenomas, we rely primarily on hot snare resection. Endoscopic mucosal resection (EMR), preferably en bloc, is appropriate for bulky nongranular conventional adenomas and nongranular adenomas with depression in this size range. For sessile serrated polyps 10 to 19 mm in size our approaches differ to some extent, with one of us using primarily “cold EMR,” and the other using primarily hot EMR technique.
New-generation full-spectrum endoscopy versus standard forward-viewing colonoscopy: a multicenter, randomized, tandem colonoscopy trial (J-FUSE Study) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-06-13 Toyoki Kudo, Yutaka Saito, Hiroaki Ikematsu, Kinichi Hotta, Yoji Takeuchi, Masaaki Shimatani, Ken Kawakami, Naoto Tamai, Yuichi Mori, Yasuharu Maeda, Masayoshi Yamada, Taku Sakamoto, Takahisa Matsuda, Kenichiro Imai, Sayo Ito, Kenta Hamada, Norimasa Fukata, Takuya Inoue, Hisao Tajiri, Kenichi Yoshimura, Hideki Ishikawa, Shin-ei Kudo
Objectives Although colonoscopy is the criterion standard for detection of colorectal adenomas, some adenomas are missed. Full-spectrum endoscopy (FUSE) allows for observation with a 330° angle of view, which is expected to decrease the miss rate. However, no consensus has been reached regarding the superiority of FUSE over standard forward-viewing colonoscopy (SFVC) for detection of adenomas; we therefore compared new-generation FUSE and SFVC regarding colorectal adenoma miss rate (AMR) in this, the first reported randomized control trial using new-generation FUSE. Methods We enrolled individuals aged 40–75 years who had been referred for screening, surveillance, fecal occult blood test positivity, or symptoms in a prospective randomized trial of tandem colonoscopy in eight institutions. Patients were randomly assigned (1:1) via computer-generated stratified randomization. Neither the endoscopists nor patients were blinded to the allocation. The primary endpoint was AMR per patient (AMR-PP). Results We enrolled 345 patients and included 319 in the per-protocol analyses. AMR-PP was significantly lower with FUSE (11.7%; 95% CI, 8.0%–15.4%) than with SFVC (22.9%; 95% CI, 17.5%–28.3%; P < 0.001). AMR-PP for lesions ≤ 5 mm in size was significantly lower with FUSE (10.4%; 95% CI, 6.5%–14.3%) than SFVC (20.0%; 95% CI, 14.4%–25.6%; P = 0.0057). Furthermore, AMR-PP in the ascending colon was significantly lower with FUSE (4.3%; 95% CI, 1.4%–7.2%) than with SFVC (10.6%; 95% CI, 6.1%–15.1%; P = 0.0212). Conclusions FUSE is superior to SFVC regarding both AMR-PP and AMR; additionally, AMR-PP were both significantly lower with FUSE than SFVC for lesions ≤ 5 mm in size and in the ascending colon. (Clinical trial registration number: UMIN000020448)
Young Patients with Sporadic Colorectal Adenomas: Current Endoscopic Surveillance Practices and Outcomes Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-06-13 Jae Myung Cha, Danielle La Selva, Richard A. Kozarek, Michael Gluck, Andrew Ross, Otto S. Lin
Background and Aims For young individuals (<40) without strong family histories that would put them at risk for genetic colorectal cancer syndromes, it is unclear if national Multi-Society Task Force surveillance recommendations apply or if endoscopists follow these guideline recommendations when such patients are incidentally found to have adenoma(s) on colonoscopy. Methods We reviewed records on young (<40-year-old) patients, with either no family history or only a “moderate” family history (one first-degree family member with colorectal cancer at age ≥50), who were found to have neoplastic polyp(s) on their index colonoscopy. We assessed the pattern of endoscopist surveillance recommendations, whether endoscopist recommendations adhered to national guidelines, and compliance with surveillance recommendations. Results 141 subjects were included, of whom 19 (13.5%) had a moderate family history of colorectal cancer. For patients with non-high–risk findings, 27.7% were asked to repeat their colonoscopy in ≤3 years, and 99.0% within 5 years. Endoscopist surveillance recommendation adherence rates to national guidelines were >65.0% for low-risk neoplasia, but lower for high-risk (40.0%), nonpolypoid (44.2%) and serrated neoplasia (54.2%, p<0.001 for all). 96% of subjects whose endoscopist recommendations were “nonadherent” to guidelines were recalled too early. Only 24.7% of subjects were actually compliant with endoscopist surveillance recommendations. Conclusions For young patients with neoplastic polyp(s) but no strong family history, most endoscopists adhered to national guidelines and recommended repeat colonoscopy in 3 to 5 years. However, relatively few patients were compliant with repeat colonoscopy recommendations. For most cases that were "nonadherent" to guidelines, patients were recalled too early as opposed to too late.
Alternative Approaches to Polyp Extraction in Colonoscopy: A Proof of Principle Study Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-06-06 Rama Behara, Shriram Jakate, Faraz Bishehsari, John Losurdo, Salina Lee, Shubha Singh, Joshua Melson
Background and Aims A limitation of determination of the completeness of resection in polypectomy is polyp fragmentation. When a polyp fragments, the pathologist cannot determine resection completeness. Alternative approaches to reduce polyp fragmentation include reducing shearing forces on the polyp or removing polyps through the instrument channel. The primary aim of this study was to assess fragmentation of polyps extracted using different approaches from conventional polyp retrieval. Methods Polyps (5-15 mm) resected by cold snare or cautery by 3 colonoscopists were extracted from the colonoscope using one of 4 techniques. Method I was the conventional method of pressing suction valve button and retrieving the polyp through a trap. Method II involved removing the suction valve, covering the open suction valve cylinder with a finger. Method III used a Roth Net polyp retriever placed through the instrument channel. Method IV involved connecting a polyp trap to suction onto the instrument channel port. Fragmentation was defined as multiple pieces of the specimen in formalin, as grossly described by the pathologist. Alternative approaches (Methods II, III, IV) were all compared to the conventional method (Method I). Results The Method I fragmentation rate of polyps was 60.3% (123/204). Method II extraction reduced fragmentation to 43.0% (52/121)(p=0.003), proving that fragmentation occurs with passage through the suction valve channel. Method III had a lower fragmentation rate of 23.1% (6/26) (p= <0.001). Method IV likewise showed reduced fragmentation rate of 18.5% (5/27) (p=<0.001). Conclusions Polyp fragmentation is reduced by removal of the suction valve button. There is also a decrease in fragmentation rates in removing polyp by connecting the polyp trap to the instrument port. Our study suggests that decreasing polyp fragmentation and improving pathology margin interpretability is possible through methods that extract polyps through the instrument port with currently available devices.
Feasibility and safety of microforceps biopsy in the diagnosis of pancreatic cysts Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-03-03 Omer Basar, Osman Yuksel, Dennis J. 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 Aims 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 microforceps biopsy (MFB) with cyst fluid cytology. Methods In this multicenter study, data of 42 patients who had cysts both aspirated by EUS-guided FNA (EUS-FNA) and biopsy specimens were then obtained with an MFB device, were collected. Cytology analysis of cyst fluid and histologic analysis of biopsy specimens were done. 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 and/or nonmucinous cysts, detection of high risk for malignancy, and specific cyst type diagnosis. Results The mean patient age was 69 years. Sixteen pancreatic cysts (38.1%) were located in the head, 17 (40.5%) in the body, and 9 (21.4%) in the tail. The mean cyst size was 28.2 mm (12-60 mm); 25 of 42 (60%) were septated. The EUS-FNA tissue (fluid) acquisition yield was 88.1% (37/42). The MFB tissue acquisition yield was 90.4% (38/42). The diagnostic cytology yield to differentiate between mucinous and/or nonmucinous cysts was 47.6% (20/42), and the MFB histologic yield to differentiate between mucinous and/or nonmucinous cysts was 61.9% (26/42) (P = .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 = .113). However, the ability of MFB to provide a specific cyst type diagnosis was 35.7% (15/42), and that for cytology was 4.8% (2/42) (P = .001). Surgical histology was concordant with that of MFB in 6 of 7 patients (85%), and with that of cytology in 1 of 7 patients (15%). Conclusion The cyst tissue acquisition yield for MFBs was 90%. Although cytology of cyst fluid and MFB were comparable in distinguishing mucinous and nonmucinous cysts and detecting cysts at high risk for malignancy, MFB was far superior to cytology for providing a specific cyst diagnosis.
Visceral obesity as a risk factor for colorectal adenoma occurrence in surveillance colonoscopy Gastrointest. Endosc. (IF 7.204) 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 2244 participants between 2006 and 2007. The study participants were prospectively followed until 2014 according to the initial colonoscopy and histopathology findings. Incident and recurrent colorectal adenoma groups were defined as individuals with a positive follow-up colonoscopy result from the normal results and adenoma groups, respectively, at the baseline colonoscopy. Results Among the 1163 patients (51.8%) who received a follow-up colonoscopy, 509 (43.8%) and 654 (56.2%) were grouped into the normal and adenoma cohorts. Colorectal adenomas occurred in 592 patients (50.9%) during the median period of 43 months, with an incident adenoma prevalence of 39.1% and a recurrent adenoma prevalence of 60.1%. An increase in the 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-standard deviation]; 95% CI, 1.10-1.60) in the multivariable analysis. Increases in body mass index and waist circumference were associated with recurrent adenomas (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. Conclusion A higher VAT area was dose-dependently associated with a higher risk of incident adenoma. Furthermore, increases in body mass index and waist circumference as surrogate markers of abdominal obesity were associated with a higher risk of recurrent adenoma.
Individualized colorectal cancer screening based on the clinical risk factors: beyond family history of colorectal cancer Gastrointest. Endosc. (IF 7.204) 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 colonoscopies and FITs were included. Clinical risk factors for ACRN were identified by 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 aged 50 to 51 years and 3.1%, 5.5%, and 7.5% among those aged ≥66 years, respectively. Among FIT-positive individuals, the prevalence of ACRN was 11.0% and 21.2% in those aged between 50 and 51 years and those aged ≥66 years, respectively. Among FIT-negative individuals with ≥2 risk score points, the prevalence of ACRN was 2.5% and 6.0% among those aged 50 to 51 years and those aged ≥66 years, respectively. Conclusion 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.
Endoscopic fistulotomy in inflammatory bowel disease (with video) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-03-06 Gursimran Kochhar, Bo Shen
Background and Aims Fistulas in patients with inflammatory bowel disease (IBD) pose a key challenge in the management of these patients. We aimed to describe a novel endoscopic method to treat patients with IBD who have fistulas. Methods A cohort of 29 consecutive patients with fistulas and IBD were identified in the registry of our interventional IBD unit. An 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; and the mean (± standard deviation) age of patients undergoing the procedure was 44.2 ± 14.6 years. Thirteen patients were male (44.8%), and 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. Conclusion Endoscopic fistulotomy with a needle-knife appears to be safe and effective in treating IBD-related fistulas.
High-definition colonoscopy versus Endocuff versus EndoRings versus full-spectrum endoscopy for adenoma detection at colonoscopy: a multicenter randomized trial Gastrointest. Endosc. (IF 7.204) 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 and Aims 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 1188 patients who completed the study, APC with Endocuff (APC mean ± standard deviation: 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 < .001 for APC). The APC for Endocuff was higher than standard HD colonoscopy (P = .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 = .006 and .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. (Clinical trial registration number: NCT02345889.)
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 7.204) 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, 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.
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 7.204) 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) because of a 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 2 groups in a 1:1 ratio. In the warning light group, the light was on when the fluoroscopy foot pedal was 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 = .045) and 856.8 μGy∙m2 versus 1054.4 μGy∙m2 (P = .043). In a multivariable analysis, the use of the warning light was found to reduce FT by 15.4% (–27.0 seconds; P = .042). DAP reduction because of the decreased FT was 15.2% (160.3 μGy∙m2). The reduction in patient effective dose per case was .42 mSv, equivalent to 21 chest radiographs. No adverse events or interference with the procedures because of 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. (Clinical trial registration number: ChiCTR-IPR-14005349.)
Efficacy of anterior versus posterior per-oral endoscopic myotomy for treating achalasia: a randomized, prospective study Gastrointest. Endosc. (IF 7.204) 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 2 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 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-second integrated relaxation pressure were significantly decreased (6.2 ± 1.3, 37.5 ± 6.7 mm Hg, and 27.3 ± 4.9 mm Hg vs .70 ± .70, 12.8 ± 2.8 mm Hg, and 11.1 ± 2.3 mm Hg, respectively; P < .01). There was no significant difference between the 2 groups in terms of general characteristics, treatment success, pre- and postoperative esophageal manometry, Eckardt score, and adverse events (P > .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. (Clinical trial registration number: ChiCTR-ICR-15007211.)
Stent placement by EUS or ERCP for primary biliary decompression in pancreatic cancer: a randomized trial (with videos) Gastrointest. Endosc. (IF 7.204) 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 a 2-week follow-up), reinterventions, and intraoperative technical outcome, when applicable. Follow-up was until death or a 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, .69; 95% confidence interval, .24-1.97; P = .49). There were no procedure-related deaths. There was no significant difference in the rates of technical success (90.9% vs 94.1%, P = .67), treatment success (97% vs 91.2%, P = .61), or reinterventions (3.0% vs 2.9%, P = .99) between EUS-BD and ERCP cohorts, respectively. The endoscopic interventions did not impede subsequent pancreaticoduodenectomy that was performed in 5 of 33 patients (15.2%) in the EUS-BD and 5 of 34 patients (14.7%) in the ERCP group (P = .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. (Clinical trial registration number: NCT03054987.)
Higher incidence of metachronous advanced neoplasia in patients with synchronous advanced neoplasia and left-sided colorectal resection for colorectal cancer Gastrointest. Endosc. (IF 7.204) 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 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 versus left-sided colorectal resection (LCR) groups (log-rank test P = .151), whereas the incidence of metachronous AN was significantly higher in patients with synchronous AN (log-rank test P < .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 < .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.
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