Adenoma detection rates in colonoscopies for positive fecal immunochemical tests versus direct screening colonoscopies Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-16 John C.T. Wong, Han-Mo Chiu, Hyun-Soo Kim, Jeong-Sik Byeon, Takahisa Matsuda, Nozomu Kobayashi, Deng-Chyang Wu, David E. Ong, Joseph J.Y. Sung,
Background and aimRecent guidelines propose higher adenoma detection rate (ADR) benchmarks for colonoscopies performed for positive fecal immunochemical tests (FIT), but this is based on low quality evidence. We aimed to compare ADR, advanced ADR (AADR), and number of adenoma per colonoscopy (APC) in direct screening colonoscopy (DSC) versus FIT positive colonoscopy (FITC) in a multicenter Asia Pacific cohort to justify differential targets.MethodsAsymptomatic average-risk subjects at or above 50 years of age who underwent screening colonoscopy directly or as follow-up for positive OC-Sensor FIT were identified from eight sites across the Asia Pacific region. Overall, sex-specific ADR, overall AADR, and overall APC were compared between the 2 screening methods. Multivariable logistic regression was performed to adjust for confounding by differences in patient characteristics. Linear regression was used to correlate ADR with APC, and to propose APC benchmarks.ResultsA total of 2,901 (mean age 60.1years, 57% men) individuals had DSC, whereas 2,485 (mean age 62.8 years, 57% men) subjects underwent FITC. Overall ADR (53.6% vs 37.5%; OR, 1.93; p<0.001), male-specific ADR (61.6% vs 44.6%; OR, 2; p<0.001), female-specific ADR (43.2% vs 28.2%; OR, 1.94; p<0.001) and overall advanced ADR (29.9% vs 4.9%; OR, 8.2; p<0.001) in FITC were significantly higher than the corresponding values for DSC. Differences remained significant after adjustment for patient characteristics. ADR was strongly and positively correlated to APC, with an ADR of 45% and 35% correlating to an APC of ∼1 and ∼0.65.ConclusionsResults from this international multicenter cohort study provide early evidence that newly proposed higher ADR targets are justified as quality indicators for FIT-positive colonoscopy.
Efficacy of autofluorescence imaging for flat neoplasm detection: a multicenter randomized controlled trial (A-FLAT trial) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-16 Yoji Takeuchi, Manabu Sawaya, Shiro Oka, Naoto Tamai, Takuji Kawamura, Toshio Uraoka, Hiroaki Ikematsu, Tomohiko Moriyama, Masamichi Arao, Hideki Ishikawa, Yuri Ito, Takahisa Matsuda
Background & AimsColorectal flat (nonpolypoid) lesions can be overlooked during colonoscopy. This study evaluated the efficacy of updated autofluorescence imaging (AFI) for detecting colorectal flat neoplasms.MethodsThis was a prospective, multicenter, randomized controlled trial in 9 Japanese tertiary institutions. Patients undergoing colonoscopy due to positive fecal immunochemical tests (FIT), surveillance after polypectomy, or investigation of minor symptoms were enrolled and randomly assigned to either the white-light imaging (WLI) or the AFI group. Primary outcome measurement was number of flat neoplasms per patient.ResultsFrom November 2015 to June 2017, 817 patients were enrolled. After excluding 15 patients, 802 were finally analyzed (404, WLI; 398, AFI). Patients’ background (sex, age, indication of colonoscopy, experience of endoscopists) and quality of colonoscopy (bowel preparation, sedative use, cecal insertion rate, insertion and withdrawal time) were not different between groups. Number of flat neoplasms in each patient (95% confidence interval) was significantly higher in AFI than in the WLI group (0.87 [0.78–0.97] vs 0.53 [0.46–0.61]), whereas overall and polypoid neoplasm detection were not significantly different between the groups (1.33 [1.22–1.45] vs 1.14 [1.03–1.24], 0.46 [0.40–0.53] vs. 0.60 [0.53–0.68]). Flat neoplasms were more frequently detected in the right-sided colon with AFI (0.61 [0.54–0.70] vs 0.30 [0.25–0.36]), but not in the left-sided colon and rectum (0.26 [0.21–0.32] vs 0.23 [0.19–0.28]).ConclusionUpdated AFI improves the detection of flat colorectal neoplasms in the right-sided colon compared with WLI (UMIN Clinical Trials Registry number, UMIN000019355).
Application of convolutional neural network in the diagnosis of the invasion depth of gastric cancer based on conventional endoscopy Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-16 Yan Zhu, Qiu-Cheng Wang, Mei-Dong Xu, Zhen Zhang, Jing Chen, Yun-Shi Zhong, Yi-Qun Zhang, Wei-Feng Chen, Li-Qing Yao, Ping-Hong Zhou, Quan-Lin Li
Background and AimsAccording to guidelines, endoscopic resection should only be performed for patients whose early gastric cancer invasion depth is within the mucosa or submucosa of the stomach regardless of lymph node involvement. The accurate prediction of invasion depth based on endoscopic images is crucial for screening patients for endoscopic resection. We constructed a convolutional neural network computer-aided detection (CNN-CAD) system based on endoscopic images to determine invasion depth and screen patients for endoscopic resection.MethodsEndoscopic images of gastric cancer tumors were obtained from the Endoscopy Center of Zhongshan Hospital. An artificial intelligence-based CNN-CAD system was developed through transfer learning leveraging a state-of-the-art pretrained CNN architecture, ResNet50. A total of 790 images served as a development dataset, and another 203 images served as a test dataset. We used the CNN-CAD system to determine the invasion depth of gastric cancer and evaluated the system’s classification accuracy by calculating its sensitivity, specificity, and area under the receiver operating characteristic curve.ResultsThe area under the receiver operating characteristic curve for the CNN-CAD system was 0.94 (95% confidence interval (CI), 0.90–0.97). At a threshold value of 0.5, sensitivity was 76.47%, and specificity was 95.56%. Overall accuracy was 89.16%. Positive and negative predictive values were 89.66% and 88.97%, respectively. The CNN-CAD system achieved significantly higher accuracy (by 17.25%; 95% CI, 11.63–22.59) and specificity (by 32.21%; 95% CI, 26.78–37.44) than human endoscopists.ConclusionsWe constructed a CNN-CAD system to determine the invasion depth of gastric cancer with high accuracy and specificity. This system distinguished early gastric cancer from deeper submucosal invasion and minimized overestimation of invasion depth, which could reduce unnecessary gastrectomy.
Intestinal metaplasia of the gastric cardia: findings in patients with versus without Barrett’s esophagus Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-14 Hassan A. Siddiki, Dora M. Lam-Himlin, Allon Kahn, M. Veronica Bandres, George E. Burdick, Michael D. Crowell, Rahul Pannala, Francisco C. Ramirez, Marcelo F. Vela, David E. Fleischer
Background and Aims There is controversy about finding intestinal metaplasia (IM) of the gastric cardia on biopsy. The most recent American GI society guideline comments that IM cardia is not more common in patients with Barrett’s. It provides limited guidance on whether the cardia should be treated when patients with Barrett’s undergo endoscopic eradication therapy (EET) and whether the cardia should be biopsied after ablation. The aims of our study were to determine the frequency in the proximal stomach of (1) histologic gastric cardia mucosa and (2) IM cardia. A third aim was to explore the frequency of advanced pathology (dysplasia and adenocarcinoma) in the cardia after Barrett’s patients have undergone EET. Methods Consecutive patients undergoing esophagogastroduodenoscopy between January 2008 and December 2014, who had proximal stomach biopsies were included. Patients who had histologically confirmed Barrett’s were compared with those without Barrett’s. Results Four hundred sixty-two patients, 289 with Barrett’s and 173 without Barrett’s, were included. Histologically confirmed cardiac mucosa was found in 81.6% of all patients. This was more frequent in those with versus without Barrett’s (86% vs 75%; OR, 2.06; 95% CI, 1.28-3.32; p=0.003). IM cardia was more common in the Barrett’s group (17% vs 7%; OR, 2.67; 95% CI, 1.38-5.19; p=0.004). Advanced pathology was more likely in the Barrett’s patients who had undergone EET. Conclusions Cardiac mucosa is present in most patients who undergo endoscopy for upper GI symptoms. IM cardia is more common in patients with Barrett’s than those without. Advanced histologic changes of the cardia were seen only in the subgroup of Barrett’s patients who had undergone EET.
Prevalence of Metastasis and Survival of 788 patients with T1 Rectal Carcinoid Tumors Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-14 Saowanee Ngamruengphong, Ayesha Kamal, Venkata Akshintala, Gulara Hajiyeva, Yuri Hanada, Yen-I. Chen, Omid Sanaei, Daniela Fluxa, Yamile Haito Chavez, Vivek Kumbhari, Vikesh Singh, Anne Marie O'Broin-Lennon, Marcia Irene Canto, Mouen A. Khashab
Background & AimsPrevalence of rectal carcinoids is increasing, partly due to increased colorectal cancer screening. Local excision (endoscopic or trans-anal excision) is usually performed for small (<1-2 cm) rectal carcinoids but data on clinical outcomes from large population-based U.S. studies are lacking. The aims of this study were to determine the prevalence of metastasis of resected small rectal carcinoid tumors using a large national cancer database and to evaluate the long-term survival of patients after local resection as compared with radical surgery.MethodsThe SEER database was used to identify 788 patients with rectal T1 carcinoids <2 cm in size. Prevalence of metastases at initial diagnosis and risk factors for metastases were analyzed. Cancer-specific survival (CSS) was calculated.ResultsA total of 727 (92.3%) patients had tumors <10 mm in diameter and 61 (7.7%) had tumors 11 to 19 mm. Overall, 12 patients (1.5%) had metastasis at the time of diagnosis with prevalence of 1.1% in lesions ≤10 mm and 6.6% in lesions 11 to 19 mm (p=0.01). Survival of patients with T1 rectal carcinoids without metastasis was significantly better than those with metastasis (5-year CSS of 100% vs 78%, p<0.001). Of 559 patients with T1N0M0 rectal carcinoids <10 mm, 5-year CSS was 100% in both groups who underwent local excision and those who underwent radical surgery.ConclusionsLarger T1 rectal carcinoid tumors (11 – 19 mm) have significantly higher risk of LN metastases compared with those ≤10 mm. Survival is worse with metastatic disease. Local therapy is adequate for T1N0M0 rectal carcinoids ≤10 mm in size with excellent long-term outcomes.
The incremental value of DNA analysis in pancreatic cysts stratified by clinical risk factors Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-14 James Farrell, Mohammad Al-Haddad, Sara A. Jackson, Tamas Gonda
Background and AimsWe determined the incremental predictive value of pancreatic cyst fluid molecular analysis to assessing malignancy risk over long term follow-up of a well-characterized cohort, given the underlying predictive value of imaging parameters routinely used to triage such patients.MethodsPatients who lacked initial cytologic malignancy in cyst fluid and had final pathology or a follow-up period of >2 years were included. Patient outcomes determined the malignancy-free survival of patients with high-risk stigmata (HRS), worrisome features (WFs) and DNA abnormalities. DNA analysis included 3 abnormalities: (1) loss of heterozygosity mutations among a panel of tumor suppressor genes, (2) Kras mutation, (3) and elevated DNA quantity.Results478 patients were included; 209 had surgical pathology derived outcomes and 269 had clinical follow-up of >2 years. 11% had malignant outcome. 42 patients had HRS, 272 lacked both HRS and WFs, and 164 lacked HRS but had WFs. DNA abnormalities did not statistically change long-term malignancy risk in patients with HRS or in patients lacking both HRS and WFs. Among patients with WFs, the presence of ≥2 DNA abnormalities significantly increased malignancy risk (RR 5.2, P=0.002) and the absence of all DNA abnormalities significantly decreased risk (RR 0.4, P=0.040). Sensitivity analysis confirmed results of survival analysis over differing baseline malignancy probabilities.ConclusionOur study defines the clinical characteristic of patients in which DNA abnormality testing has the greatest impact on patient outcomes. Use of DNA abnormality testing is supported in a carefully selected patient population limited to cysts with worrisome features.
EUS-guided fiducial placement for GI malignancies: a systematic review and meta-analysis Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-13 Emmanuel Coronel, Irina Mihaela Cazacu, Atsushi Sakuraba, Adriana Alexandra Luzuriaga Chavez, Angad Uberoi, Yimin Geng, Yutaka Tomizawa, Adrian Saftoiu, Eun Ji Shin, Cullen M. Taniguchi, Albert C. Koong, Joseph M. Herman, Manoop S. Bhutani
Background and AimsImage-guided radiotherapy (IGRT) allows the delivery of radiation with high precision to a target lesion while minimizing toxicity to surrounding tissues. Endoscopic ultrasound (EUS) provides excellent visualization of GI tumors and consequently is being used for fiducial placement with increased frequency. Our goal was to perform a systematic review and meta-analysis of studies evaluating the technical aspects, safety and efficacy of EUS fiducial placement for IGRT in GI malignancies.MethodsA systematic literature search was carried out in the following databases: Medline, Pubmed, Embase, Web of Science and Cochrane Library, using Medical Subject Headings terms combined with text words. A random effects model was used to determine pooled proportions of technical success, migration and adverse events rates. Heterogeneity was assessed using the I2 statistic. Publication bias was visually inspected by using a funnel plot and by the Begg’s and Egger’s tests.ResultsNine full articles and 5 abstracts reporting on 1155 patients, 49% from a single study by Dhadham et al, were included in the meta-analysis. Pooled rate of technical success was 98% (95% CI, 96-99). Moderate heterogeneity (I2 = 34.18) was present, which appeared to be due to variable sample sizes. Publication bias was present suggesting that studies with less substantial outcomes may have not been reported (Begg’s test p = 0.87, Egger’s test p<0.01). Pooled rates for fiducial migration and adverse events were 3% (95% CI, 1.0-8.0) and 4% (95% CI, 3-7), respectively.ConclusionsOur meta-analysis showed that EUS-guided insertion of gold fiducials for IGRT is technically feasible and safe. Further controlled studies assessing its long-term effectiveness in gastrointestinal malignancies are needed.
Blue-light imaging has an additional value to white-light endoscopy in visualization of early Barrett's neoplasia. an international multicenter cohort study Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-09 A.J. de Groof, A. Swager, R.E. Pouw, B.L.A.M. Weusten, E.J. Schoon, R. Bisschops, O. Pech, A. Meining, H. Neuhaus, W.L. Curvers, J.J. Bergman
Background and Aims Endoscopic features of early neoplasia in Barrett's esophagus (BE) are subtle. Blue-light imaging (BLI) may improve visualization of neoplastic lesions. The aim of this study was to evaluate BLI in visualization of Barrett’s neoplasia. Methods Corresponding whit- light endoscopy (WLE) and BLI images of 40 BE lesions were obtained prospectively and assessed by 6 international experts in 3 assessments. Each assessment consisted of overview and magnification images. Assessments were as follows: Assessment 1: WLE only; Assessment 2: BLI only; and Assessment 3: corresponding WLE and BLI images. Outcome parameters were as follows: (1) appreciation of macroscopic appearance and surface relief (VAS-scores); (2) ability to delineate lesions (VAS-scores); (3) preferred technique for delineation (ordinal scores); and (4) quantitative agreement on delineations (AND/OR scores). Results Experts appreciated BLI significantly better than WLE for visualization of macroscopic appearance (median 8.0 vs 7.0, P<0.001) and surface relief (8.0 vs 6.0, P<0.001). For both overview and magnification images, experts appreciated BLI significantly better than WLE for ability to delineate lesions (8.0 vs 6.0, P<0.001 and 8.0 vs 5.0, P<0.001). There was no overall significant difference in AND/OR scores of WLE+BLI when compared with WLE, yet agreement increased significantly with WLE+BLI for cases with a low baseline AND/OR score on WLE, both in overview (mean difference 0.15, P=0.015) and magnification (mean difference 0.10, P=0.01). Conclusions BLI has additional value for visualization of BE neoplasia. Experts appreciated BLI better than WLE for visualization and delineation of BE neoplasia. Quantitative agreement increased significantly when BLI was offered next to WLE for lesions that were hard to delineate with WLE alone.
Efficacy of 3 fine-needle biopsy techniques for suspected pancreatic malignancies in the absence of an on-site cytopathologist Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-04 Ka Young Lee, Hyun Deuk Cho, Young Hwangbo, Jae Kook Yang, Su Jung Han, Hyun Jong Choi, Yun Nah Lee, Sang-Woo Cha, Jong Ho Moon, Young Deok Cho, Sang-Heum Park, Tae Hoon Lee
Background and Aims EUS-guided fine-needle aspiration/biopsy (EUS-FNA/B) has a high diagnostic accuracy for pancreatic tumors. Most reports have focused on the diagnostic yield of cytology or histology; the ability of various FNA/B techniques to obtain an adequate mass of cells or tissue has rarely been investigated. Methods Patients with suspected pancreatic malignancy were sampled by EUS-FNB using a 22-gauge ProCore needle by either the stylet slow-pull-back technique (group A), conventional negative-suction after stylet removal (group B) or non-suction after stylet removal (group C) in the absence of on-site cytopathologist. The adequacy of 3 techniques based on the diagnostic yield, cellularity, blood contamination, and core-tissue acquisition was evaluated. Results A total of 50 patients (27 males) were analyzed. The mean tumor size was 21 to 40 mm in 54%. The rate of a good or excellent proportion of cellularity was highest in group A compared with groups B and C (72% vs 60% vs 50%, p = 0.049). A >25% rate of blood contamination was more prevalent in group B (30% vs 42% vs 10%, p = 0.009). The rate of adequate core-tissue acquisition was not different (52% vs 34% vs 50%, p = 0.140). Based on the multivariate generalized estimation equation, stylet slow-pull-back technique and a tumor size of >40 mm were a favorable factor for diagnostic adequacy. Conclusions The stylet slow-pull-back technique might enable acquisition of tissue and assessment of cellularity for the diagnosis of pancreatic tumors suspected to be malignant.
Application of deep learning to predict advanced neoplasia using big clinical data in colorectal cancer screening of asymptomatic adults Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-04 Hyo-Joon Yang, Chang Woo Cho, Sang Soo Kim, Kwang-Sung Ahn, Soo-Kyung Park, Dong Il Park
Background and Aims We aimed to develop deep learning models for the prediction of the risk of advanced colorectal neoplasia (ACRN) in asymptomatic adults based on which colorectal cancer screening could be customized. Methods We collected data on 26 clinical and laboratory parameters including age, sex, smoking status, body mass index, complete blood count, blood chemistry, and tumor marker from 70,336 first-time screening colonoscopy recipients. For reference, we used a logistic regression (LR) model with nine variables. Two deep neural network (DNN) models were developed: Model 1 used the same nine variables and Model 2 included all 26 variables. The area under the receiver operating characteristic curve (AUC), sensitivity, and specificity were compared for the models in a randomly split test set. Results Compared with the LR model (AUC, 0.721; 95% confidence interval [CI], 0.680–0.762), the DNN Model 1 (AUC, 0.817; 95% CI, 0.789–0.847) and Model 2 (AUC, 0.860; 95% CI, 0.837–0.883) showed significantly improved performance with respect to the prediction of ACRN (both P<.001). For a sensitivity of 80%, the specificity of the LR, and DNN Models 1 and 2 were 50.5%, 65.8%, and 78.8%, respectively (both P vs LR model < .001), indicating that the colonoscopy workload required to detect a similar number of ACRNs could be reduced by 58.4% and 73.7% using the DNNs. Conclusions The application of DNNs to big clinical data could significantly improve the prediction of ACRNs compared with the LR model, implying the potential for realizing further improvements using large quantities and various types of biomedical information.
Efficacy and safety of EUS-guided liver biopsy: a systematic review and meta- analysis Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-31 Babu P. Mohan, Mohammed Shakhatreh, Rajat Garg, Suresh Ponnada, Douglas G. Adler
Risk of bacterial exposure to the endoscopist’s face during endoscopy Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-01 Elyse R. Johnston, Nadia Habib-Bein, Jeffrey M. Dueker, Barbara Quiroz, Enrico Corsaro, Megan Ambrogio, Michael Kingsley, Georgios I. Papachristou, Christianna Kreiss, Asif Khalid
Background and Aims Non-universal use of facial protection during endoscopy may place endoscopists at risk of exposure to blood and body fluids; however, the frequency of exposure is unknown. Methods A prospective 6-month study of 4 gastroenterologists using a face shield during endoscopy was undertaken. The face shield was swabbed in a standardized fashion before and at the end of the session. Controls included pre- and post-swabs of face shields placed on the (1) endoscopy suite wall, (2) remote patient intake bay wall, and (3) after deliberate contamination with a colonoscope immediately after colonoscopy. The swabs were cultured for 48 hours and growth reported as no growth or by number of colony-forming units (CFU). The groups were compared for +CFU rate and CFU number. Results A total of 1100 procedures were performed in 239 endoscopy sessions. The +CFU rate in the pre-endoscopy groups (2-4.8% p=NS) was significantly lower than the post-endoscopist face shield (45.8%, p<0.001), and endoscopy suite wall groups (21.4%, p<0.001), respectively. Using a cut-off of >15 CFU as an indicator of definite exposure, the occurrence rate was 5.6 per 100 half days of endoscopy to the endoscopists face and 3.4 per 100 days of endoscopy 6 feet away. Conclusions This is the first study to quantify the rate of unrecognized exposure to the endoscopist’s face to potentially infectious biological samples during endoscopy (5.6/100 days of endoscopy). This exposure may result in transmission of infectious diseases. As such, we recommend the use of universal facial protection during GI endoscopy.
Transvaginal natural orifice transluminal endoscopic surgery in the diagnosis of ascites of unknown origin Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-11-01 Shu-ling Li, Li Zhao, Zi-kai Wang, Wen Li
Background and Aims Natural orifice transluminal endoscopic surgery (NOTES) has been established in animal models and human studies, but few clinical studies have investigated transvaginal NOTES in the diagnosis of unexplained refractory ascites. We aimed to assess the feasibility, efficacy, and safety of transvaginal NOTES for the diagnosis of unexplained ascites in female patients. Methods A prospective study was done involving 3 female patients with unexplained ascites. After general anesthesia and disinfection, a 1.0-cm incision was made in the posterior fornix of the vagina. A gastroscope was inserted into the abdominal cavity through the transvaginal incision and an artificial pneumoperitoneum was created; NOTES peritoneoscopy was performed to scrutinize the pathologic changes. Endoscopic biopsies were obtained for pathological examination. The transvaginal incision was closed by direct suturing. Results Transvaginal NOTES for diagnostic peritoneoscopy was successfully performed in 3 patients. The mean operative time was 61 minutes. The estimated blood loss was 5 to 10 mL. The pathological diagnoses were tuberculosis for all patients, and the symptoms and ascites disappeared after anti-tuberculosis therapy. During the 4-year follow-up, no clinically significant adverse events occurred in any patient after NOTES. No patient experienced an annex inflammation, vaginitis, dyspareunia, or sexual dysfunction. All patients were comfortable and satisfied with the nonscarring surgical procedure. Conclusion Transvaginal NOTES for the diagnosis of unexplained ascites is feasible, effective and safe. This method had no long-term effect on female sexual function and is particularly suitable for women who have special aesthetic requirements. (Clinical trial registration number: ChiCTR-TRC-10001053.)
Endosheath ultrathin transnasal endoscopy is a cost-effective method for screening for Barrett’s esophagus in patients with GERD symptoms Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-29 Judith Honing, Wietske Kievit, Jan Bookelaar, Yonne Peters, Prasad G. Iyer, Peter D. Siersema
Background and Aims Barrett’s esophagus (BE) screening is currently not considered to be cost effective in the general population but may be effective in high-risk subgroups, such as 50-year-old white men with chronic reflux disease (GERD). A new modality for screening is unsedated transnasal endoscopy using endosheath technology (uTNE), which has been shown to be safe and effective in clinical practice. In this study, we determined the cost-utility of uTNE in a high-risk subgroup compared with no screening or screening with standard endoscopy (SE). Methods A Markov model was used to simulate screening of 50-year-old white men with symptoms of GERD with either uTNE or standard endoscopy compared with no screening, over a lifetime horizon. Input variables were based on the literature and recent data on uTNE screening for BE. The study was designed from a healthcare payer perspective using direct costs. Primary outcome measures were costs, quality-adjusted life-years (QALY) and incremental cost-utility ratio (ICUR) of uTNE and standard endoscopy compared with no screening. Sensitivity analysis was performed for several factors such as prevalence of BE. Results Costs of uTNE, standard endoscopy, and no screening were estimated at, respectively, $2495, $2957, and $1436. Compared with no screening, uTNE screening resulted in an overall QALY increase of 0.039 (95% percentile 0.018; 0.063) and an ICUR of $29,446 per QALY gained (95% CI, 18.516 – 53.091), whereas standard endoscopy compared with no screening resulted in a QALY increase of 0.034 (95% CI, 0.015 - 0.056) and an ICUR of $47,563 (95% CI, 31.0361 – 82.970). Conclusions Both uTNE and standard endoscopy seem cost effective screening methods in a screening cohort of 50-year-old white men with GERD at a willingness to pay cut-off of $50,000.
Durability of radiofrequency ablation for treatment of esophageal squamous cell neoplasia: 5-year follow-up of a treated cohort in China Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-26 X. Yu, S.N. van Munster, Y. Zhang, L. Xue, D.E. Fleischer, B. Weusten, N. Lu, S.M. Dawsey, J.J.G.H.M. Bergman, G. Wang
Background and aims Radiofrequency ablation (RFA) is accepted treatment for flat Barrett’s neoplasia. Less is known about RFA for esophageal squamous-cell neoplasia (ESCN). Our group has reported several prospective studies of RFA for ESCN in China with promising results through 12 months of follow-up. In this cohort study, we aimed to evaluate longer-term outcomes after RFA for ESCN. Methods Patients with flat unstained lesions (USLs) on Lugol’s endoscopy containing moderate/high-grade intra-epithelial neoplasia (MGIN/HGIN) or mucosal cancer were treated with RFA every 3 months until complete remission (CR; no MGIN+). Patients with CR at 12 months (CR12) were included for follow-up and underwent annual Lugol’s endoscopy with biopsies and re-RFA for flat USLs. The clinical course of patients with persistent ESCN at 12 months (treatment failures) is also reported. Results Among the 78 CR12 patients, 67 (86%) had sustained CR during a median 48 months (IQR 48-48) of follow-up and 5 endoscopies (IQR 4-6). Recurrence occurred in 7 out of 78 patients (9%; MGIN(6), HGIN(1)); all lesions were managed with RFA. Four other patients (5%) had progression (to HGIN(n=1); ESCC-sm(n=3)). During follow-up, protocol violations occurred in 46 of 78 patients (59%). Of the 12 treatment failures, progression occurred in 6. Overall, 2 patients developed subepithelial disease that was not visible after Lugol’s. Based on post-hoc analysis, the pink-color sign at baseline (a pink color change after Lugol’s) significantly predicted failure after RFA. Conclusion RFA is relatively easy to apply and can efficiently treat large areas with ESCN. Despite protocol violations that may have interfered with the efficacy of RFA in 59% of patients, the great majority with CR12 had sustained CR during follolw-up. However, some patients progressed to advanced disease and 2 developed subepithelial disease, not visible after Lugol’s. Based on currently available data, we advise to restrict the use of RFA for flat MGIN and HGIN without the pink-color sign on Lugol’s chromoendoscopy.
Successful hemostasis of active lower GI bleeding using a hemostatic powder as monotherapy, combination therapy, or rescue therapy Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-26 Lawrence Hookey, Alan Barkun, Richard Sultanian, Robert Bailey
Background and Aims Acute lower GI bleeding is a frequent cause of hospital admission. The objective of this study was to evaluate the safety and performance of a hemostatic powder (TC-325/Hemospray) in the treatment of nonvariceal lower GI bleeding. Methods Patients were enrolled into this prospective, multicenter, single-arm study at 4 tertiary care centers in Canada. Fifty patients with active lower GI bleeding of multiple different etiologies (52 bleeding sites) underwent topical endoscopic application of hemostatic powder. The primary endpoint was powder-related adverse events within 30 days of the index procedure. Secondary endpoints were initial hemostasis as well as recurrent bleeding and mortality within 30 days of the index procedure. Results Most patients (96%) had a single bleeding site and most bleeding (73%) was due to polypectomy. Overall, the powder was applied as monotherapy in 13 bleeding sites (25%), as combination therapy in 22 bleeding sites (42.3%), and as rescue therapy in 17 bleeding sites (32.7%). Hemostasis was achieved in 98% of patients. No patient experienced a powder-related adverse event. Five patients (10%) developed recurrent bleeding within 30 days. One patient (2%) died within 30 days of powder application, but the death was not directly related to hemostatic powder use. Conclusions The hemostatic powder is a safe and effective option for patients with lower gastrointestinal bleeding of varying etiologies, and in particular, postpolypectomy hemorrhage. The hemostatic powder is effective as monotherapy, part of a combination approach, or as a rescue therapeutic option for the treatment of nonvariceal lower GI bleeding.
Automatic detection of erosions and ulcerations in wireless capsule endoscopy images based on a deep convolutional neural network Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-25 Tomonori Aoki, Atsuo Yamada, Kazuharu Aoyama, Hiroaki Saito, Akiyoshi Tsuboi, Ayako Nakada, Ryota Niikura, Mitsuhiro Fujishiro, Shiro Oka, Soichiro Ishihara, Tomoki Matsuda, Shinji Tanaka, Kazuhiko Koike, Tomohiro Tada
Background and Aims Although erosions and ulcerations are the most commonly found small-bowel abnormalities on wireless capsule endoscopy (WCE), a computer-aided detection method has not been established. We aimed to develop an artificial intelligence system with deep learning to automatically detect erosions and ulcerations in WCE images. Methods We trained a deep convolutional neural network (CNN) system based on a Single Shot Multibox Detector, using 5,360 WCE images of erosions and ulcerations. We assessed its performance by calculating the area under the receiver operating characteristic curve (ROC-AUC), and its sensitivity, specificity, and accuracy using an independent test set of 10,440 small-bowel images including 440 images of erosions and ulcerations. Results The trained CNN required 233 seconds to evaluate 10,440 test images. The AUC for the detection of erosions and ulcerations was 0.958 (95% confidence interval [CI], 0.947-0.968). The sensitivity, specificity, and accuracy of the CNN were 88.2% (95% CI, 84.8%-91.0%), 90.9% (95% CI, 90.3%-91.4%), and 90.8% (95% CI, 90.2%-91.3%), respectively, at a cut-off value of 0.481 for the probability score. Conclusions We developed and validated a new system based on CNN to automatically detect erosions and ulcerations in WCE images. This may be the crucial step for the development of a daily-use diagnostic software for WCE images to help reduce oversights and the burden on physicians.
Prediction of individuals at high absolute risk of esophageal squamous cell carcinoma Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-25 Qiao-Li Wang, Jesper Lagergren, Shao-Hua Xie
Background and Aims This study aimed to develop a prediction model for identifying individuals at high absolute risk of esophageal squamous cell carcinoma (ESCC) for endoscopic screening at a curable stage based on readily identifiable risk factors. Methods This was a nationwide Swedish population-based case-control study, including 167 new cases of ESCC and 820 randomly selected control participants. Odds ratios with 95% confidence intervals (CI) were assessed using multivariable unconditional logistic regression. The discriminative accuracy of the model was assessed by the area under the receiver operating characteristic curve (AUC) with leave-one-out cross-validation. Models for projecting individuals’ absolute 5-year risk of ESCC were developed by incorporating the age- and sex-specific incidence rates and competing risk of death from other causes. Results A model including the risk factors age, sex, tobacco smoking, alcohol overconsumption, education, duration of living with a partner, and place of residence during childhood generated an AUC of 0.81 (95% CI, 0.77-0.84). A model based only on age, sex, tobacco smoking, and alcohol overconsumption obtained a similar AUC (0.79; 95% CI, 0.75-0.82). A 5-year follow-up of 761 men aged 70 to 74 years with over 35 years’ smoking and alcohol overconsumption history is needed to detect one ESCC case. The estimated individuals’ absolute 5-year risk of ESCC varied according to combinations of risk factors. Conclusions This “easy-to-use” risk prediction model showed a good discriminative accuracy and had the potential to identify individuals at high absolute risk of ESCC who might benefit from tailored endoscopic screening and surveillance.
Underwater endoscopic mucosal resection for colorectal lesions: a systematic review with meta-analysis (with video) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-25 Marco Spadaccini, Lorenzo Fuccio, Laura Lamonaca, Leonardo Frazzoni, Roberta Maselli, Milena Di Leo, Piera Alessia Galtieri, Vincenzo Craviotto, Ferdinando D’Amico, Cesare Hassan, Alessandro Repici
Background and Aims Underwater endoscopic mucosal resection (UEMR) is an alternative way to have nonpedunculated colorectal (CR) lesions lifted before being resected. The endoscopist takes advantage of the behavior of mucosal lesions floating away from the muscular layer, once immersed in liquid. We performed a systematic review with meta-analysis to evaluate the efficacy and safety of this technique. Methods Electronic databases (Medline, Scopus, EMBASE) were searched up to May 2018. Full articles including patients with CR lesions resected by the UEMR technique were eligible. The complete resection (primary outcome), en-bloc resection, recurrence and adverse event rates were pooled by means of a random- or fixed-effect model. Results Ten studies were eligible providing data on 508 lesions removed in 433 patients (m/f=239/194; means ages range: 62.2-75.0 years). Six studies were performed in United States and the other in Europe; 7 studies were prospective. The specific indications for performing UEMR varied widely across the studies. Complete resection rate was 96.36% (95% CI, 91.77-98.44) with a rate of en-bloc resection of 57.07% (95% CI, 43.20%-69.91%). The recurrence rate was 8.82% (95% CI, 5.78-13.25) in a mean endoscopic surveillance period of 7.7 months (range 4-15). The postprocedural bleeding rate was 2.85% (95% CI, 1.64-4.90). Intraprocedural bleedings were always mild and were considered as part of the procedure in all series. The overall adverse events rate was 3.31% (95% CI, 43.20%-69.91%). No cases of perforation were reported. Conclusion According to the results of this systematic review, UEMR appears to be an effective and extremely safe technique for resecting nonpolypoid colorectal lesions.
Comparing adenoma and polyp miss rates for total underwater colonoscopy versus standard CO2: a randomized controlled trial using a tandem colonoscopy approach Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-24 Joseph C. Anderson, Charles J. Kahi, Andrew Sullivan, Margaret MacPhail, Jonathan Garcia, Douglas K. Rex
Background and Aims Although water exchange may improve adenoma detection when compared to CO2, it is unclear whether water is a better medium to fill the lumen during withdrawal and visualize the mucosa. Total underwater (TUC) involves the use of water exchange with the air valve off during insertion followed by the inspection of the mucosa under water. Our goal was to use a tandem colonoscopy design to compare miss rates for TUC to standard CO2 for polyps and adenomas. Methods We randomized participants (NCT03231917; clinicaltrials.gov) to undergo tandem colonoscopies using TUC or CO2 first. In TUC, water exchange was performed during insertion and withdrawal was performed under water. For the CO2 colonoscopy both insertion and withdrawal were performed with CO2. The main outcomes were miss rates for polyps and adenomas for the first examination calculated as the number of additional polyps/adenomas detected during the second examination divided by the total number of polyps/adenomas detected for both examinations. Inspection times were calculated by subtracting time for polypectomy and care was given to keep the times equal for both examinations. Results A total of 121 participants were randomized with 61 having CO2 first. The overall miss rate for polyps was higher for the TUC first group (81/237; 34%) as compared to the CO2 first cohort (57/264; 22%)(p=0.002). In addition, the overall miss rate for all adenomas was higher for the TUC first group (52/146; 36%) as compared with the CO2 group (37/159; 23%) (p=0.025). However, 1 of the 3 endoscopists had higher polyp/adenoma miss rates for CO2 but these were not statistically significant differences. The insertion time was longer for TUC than CO2. After adjusting for times, participant characteristics and bowel preparation, the miss rate for polyps was higher for TUC than CO2. Conclusions We found that TUC had an overall higher polyp and adenoma miss rate than colonoscopy performed with CO2, and TUC took longer to perform. However, TUC may benefit some endoscopists, an issue that requires further study.
Novel Computer-assisted Diagnosis System for Endoscopic Disease Activity in Patients with Ulcerative Colitis Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-24 Tsuyoshi Ozawa, Soichiro Ishihara, Mitsuhiro Fujishiro, Hiroaki Saito, Youichi Kumagai, Satoki Shichijo, Kazuharu Aoyama, Tomohiro Tada
Background and Aims Evaluation of endoscopic disease activity for patients with ulcerative colitis (UC) is important when determining the treatment of choice. However, endoscopists require a certain period of training to evaluate the activity of inflammation properly, and interobserver variability exists. Therefore, we constructed a computer-assisted diagnosis (CAD) system using a convolutional neural network (CNN) and evaluated its performance using a large data set of endoscopic images from patients with UC. Methods A CNN-based CAD system was constructed based on GoogLeNet architecture. The CNN was trained using 26,304 colonoscopy images from a total number of 841 patients with UC, which were tagged with anatomical locations and Mayo endoscopic scores. The performance of the CNN in identifying normal mucosa (Mayo 0) and mucosal healing state (Mayo 0–1) were evaluated in an independent test set of 3,981 images from 114 patients with UC, by calculating the areas under the receiver operating characteristic curves (AUROCs). Additionally, AUROCs in the right side of the colon, left side of the colon, and rectum were evaluated. Results The CNN-based CAD system showed a high level of performance with AUROCs of 0.86 and 0.98 to identify Mayo 0 and 0–1, respectively. The performance of the CNN was better in the rectum than in the right side and left side of the colon when identifying Mayo 0 (AUROC= 0.92, 0.83, and 0.83, respectively). Conclusions The performance of the CNN-based CAD system was robust when used to identify endoscopic inflammation severity in patients with UC, highlighting its promising role in supporting less experienced endoscopists and reducing interobserver variability.
A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-24 Priscilla A. van Riet, Alberto Larghi, Fabia Attili, Guido Rindi, Nam Quoc Nguyen, Andrew Ruszkiewicz, Masayuki Kitano, Takaaki Chikugo, Harry Aslanian, James Farrell, Marie Robert, Adebowale Adeniran, Schalk van der Merwe, Tania Roskams, Kenneth Chang, Fritz Lin, John G. Lee, Paolo Giorgio Arcidiacono, Marco J. Bruno
Background and Aims Several studies have compared EUS fine-needle aspiration (FNA) with biopsy (FNB) needles, but none has proven superiority. We performed a multicenter randomized controlled trial to compare the performance of a commonly used 25-gauge FNA needle with a newly designed 20-gauge FNB needle. Methods Consecutive patients with a solid lesion were randomized in this international multicenter study between a 25-gauge FNA (EchoTip Ultra) or a 20-gauge FNB needle (ProCore). Primary endpoint was diagnostic accuracy for malignancy and the Bethesda classification (non-diagnostic, benign, atypical, malignant). Technical success, safety, and sample quality were also assessed. Multivariable and supplementary analyses were performed to adjust for confounders. Results A total of 608 patients were allocated to FNA (n=306) or FNB (n=302); 312 pancreatic lesions (51%), 147 lymph nodes (24%), and 149 other lesions (25%). Technical success rate was 100% for the 25-gauge FNA and 99% for the 20-gauge FNB needle (p=0.043), without differences in adverse events. The 20-gauge FNB needle outperformed 25-gauge FNA in terms of histological yield (77% vs 44%, p<0.001), accuracy for malignancy (87% vs 78%, p=0.002) and Bethesda classification (82% vs 72%, p=0.002). This was robust when corrected for indication, lesion size, number of passes, and presence of an on-site pathologist (OR, 3.53; 95% CI, 1.55-8.56; p=0.004), and did not differ between centers (p=0.836). Conclusion The 20-gauge FNB needle outperformed the 25-gauge FNA needle in terms of histological yield and diagnostic accuracy. This benefit was irrespective of the indication and consistent among participating centers, supporting the general applicability of our findings.
Role of interventional inflammatory bowel disease in the era of biological therapy: a position statement from the Global Interventional IBD Group Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-24 Bo Shen, Gursimran Kochhar, Udayakumar Navaneethan, Xiuli Liu, Francis A. Farraye, Yago Gonzalez Lama, David Bruining, Darrell S. Pardi, Martin Lukas, Martin Bortlik, Kaicun Wu, Ajit Sood, David A. Schwartz, William J. Sandborn,
Interventional (or therapeutic) inflammatory bowel disease (IBD) endoscopy has an expanding role in the treatment of disease and surgical adverse events. Endoscopic therapy has been explored and used in the management of strictures, fistulas/abscesses, colitis-associated neoplasia, post-surgical acute or chronic leaks, and obstructions. The endoscopic therapeutic modalities include balloon dilation, stricturotomy, stent placement, fistulotomy, fistula injection and clipping, sinusotomy, endoscopic mucosal resection, and endoscopic submucosal dissection. With a better understanding of the disease course of IBD, improved long-term impact of medical therapy, and advances in endoscopic technology, we can foresee interventional IBD becoming an integrated part of the multidisciplinary approach to patients with complex IBD.
Diagnostic Yield and Miss Rate of EndoRings in an Organized Colorectal Cancer Screening Program: the SMART (Study Methodology for ADR-Related Technology) Trial Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-24 Cesare Hassan, Carlo Senore, Gianpiero Manes, Lorenzo Fuccio, Federico Iacopini, Luigi Ricciardiello, Andrea Anderloni, Leonardo Frazzoni, Riccardo Ballanti, Germana de Nucci, Dora Colussi, Davide Radaelli, Roberto Lorenzetti, Massimo Devani, Ilaria Arena, Cristina Grossi, Fabio Andrei, Eleonora Balestrazzi, Alessandro Repici
Background and aims The add-on EndoRings has been claimed to improve adenoma detection at colonoscopy, but available data are inconsistent. When testing a new technology, parallel and crossover methodologies measure different outcomes, leaving uncertainty on their correspondence. Aims of this study were to compare the diagnostic yield and miss rate of the EndoRings for colorectal neoplasia. Methods Consecutive subjects undergoing colonoscopy after a positive fecal immunochemical test (FIT) within organized screening program in 7 Italian centers, were randomized between a parallel (EndoRings or Standard) or a crossover (EndoRings/Standard or Standard/EndoRings) methodology. Outcomes measures were the detection rates of (advanced) adenomas (A-)ADR in the parallel arms and miss rate of adenomas in the crossover arms. Results Of 958 eligible subjects, 927 (317 EndoRings; 317 Standard; 142 EndoRings/Standard; 151 Standard/Endorings) were included in the final analysis. In the parallel arms (mean ADR: 51.3%; mean AADR: 25.4%), no difference between Standard and EndoRings was found for both ADR (RR, 1.10; 95% CI, 0.95-1.28) and A-ADR (RR, 1.16; 95% CI, 0.88-1.51), as well as for the mean number of adenomas and advanced adenomas per patient (EndoRings: 1.9±1.3 and 1.0±1.2; Standard 2.1±1.5 and 1.0±1.2; p=NS for both comparisons). In the crossover arms, no difference in miss rate for adenomas between EndoRings and Standard was found at per-polyp (RR, 1.43; 95% CI, 0.97-2.10), as well as at per-patient analysis (24% vs 26%; p=0.76). Conclusions No statistically significant difference in diagnostic yield and miss rate between EndoRings and Standard colonoscopy was detected in FIT+ patients. A clinically relevant correspondence between miss and detection rates was shown, supporting a cause-effect relationship.; Acronyms: E: Endorings; S: Standard; CRC: colorectal cancer; FIT: faecal immunochemical test; (A-) ADR: (Advanced-) adenoma detection rate; SSP: sessile serrated polyp; DR: detection rate
Comparison of Flexible Endoscopic Cricopharyngeal Myectomy and Myotomy Approaches for Zenker Diverticulum Repair a Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-17 Maoyin Pang, Andree Koop, Bhaumik Brahmbhatt, Michael J. Bartel, Timothy A. Woodward
Background and Aims Incision of the cricopharyngeal (CP) muscle with flexible endoscopy is an important approach for Zenker diverticulum (ZD) repair with symptomatic resolution in approximately 90% of cases, but recurrence has been reported in up to 20%. We report our experience with a new endoscopic myectomy of the CP muscle and compare the outcome with conventional myotomy of ZD. Methods Our retrospective study included all patients with ZD who underwent endoscopic repair between August 1, 2014, and July 31, 2017. Conventional CP myotomy was defined as a vertical cut through the CP muscle. CP myectomy was defined as parallel excisions followed by snare resection at the CP resection base. Measurement of ZD size was based on barium esophagram and endoscopic estimation. Outcomes included ZD recurrence, improvement of dysphagia, and procedure adverse events. Results Sixty-four patients underwent endoscopic repair for ZD, 44 had CP myotomy and 20 had CP myectomy. Mean (SD) size of ZD was 3.3 (1.0) cm and 3.8 (1.2) cm in the myotomy and myectomy cohorts, respectively (P = .11), and median (range) procedure time was 50 and 56 minutes, respectively (P = .73). In the CP myotomy cohort, 10 (22.7%) patients had recurrence of ZD at a median (range) of 19.1 months, whereas no recurrence has been documented in the CP myectomy cohort (P = .02). This trend was also shown in multivariate analysis even though no statistical significance (P = .07). There was no statistical difference in improvement of dysphagia and adverse events. Conclusions CP myectomy is a new endoscopic technique for ZD repair. In our experience, it was safe and well tolerated, with a high initial success rate and less ZD recurrence when compared with myotomy.
The comparison of monopolar hemostatic forceps with soft coagulation versus hemoclip for peptic ulcer bleeding: a randomized trial (with video) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-17 Bilal Toka, Ahmet Tarik Eminler, Cengiz Karacaer, Mustafa Ihsan Uslan, Aydin Seref Koksal, Erkan Parlak
Background and Aims Although various methods are used in the treatment of peptic ulcer bleeding, there is not a standard recommended approach. The choice depends on multiple factors such as location of the ulcer, clinical experience of endoscopist and local facilities of the clinic. We aimed to compare the efficacy of monopolar hemostatic forceps soft coagulation (MHFSC) and hemoclips (HC) in the treatment of peptic ulcer related upper GI bleeding. Patients and Methods The study group included patients who had GI bleeding due to Forrest 1a, 1b, 2a gastric or duodenal ulcers within 1 year. Patients with bleeding diathesis, history of gastrectomy, pregnancy, or <18 years were excluded. The remaining were randomized to MHFSC and HC treatment groups and compared in terms of clinical and endoscopic features, initial hemostasis success rates, recurrent bleeding rates within the first 7 days, time to achieve hemostasis, length of hospitalization stay, and adverse events. Results One hundred twelve patients were randomized to MHFSC (n=56) and HC (n =56) groups. There was no statistically significant difference between the groups with respect to demographic features, medications, underlying chronic diseases, location and Forrest classification of the ulcers. The initial hemostasis success rate was 98.2% (55/56) in the MHFSC group and 80.4% (45/56) in the HC group (p=0.004). Recurrent bleeding was detected in 2 patients in the MHFSC group (3.6%) and 8 patients in the HC group (%17.7%) (p=0.04). The duration of endoscopic procedures (302 ± 87.8 vs 568 ± 140.4 seconds) and the length of hospital stay were significantly shorter (3.50 ± 1,03 vs 4.37 ± 1.86 days) in the MHFSC group. There were no adverse events in both groups. Conclusion MHFSC is more effective in achieving initial hemostasis compared with HC in the treatment of peptic ulcer bleeding and provides a shorter procedure time and a lower recurrent bleeding rate.
Increasing prevalence of high-grade dysplasia and adenocarcinoma on index endoscopy in Barrett’s esophagus over the past 2 decades: data from a multicenter U.S. consortium Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-17 Madhav Desai, David A. Lieberman, Kevin F. Kennedy, Nour Hamade, Prashanthi Thota, Sravanthi Parasa, Venkat Subhash Gorrepati, Ajay Bansal, Neil Gupta, Srinivas Gaddam, Patrick E. Young, Sharad Mathur, Fouad J. Moawad, Brooks D. Cash, Richard Sampliner, John J. Vargo, Gary W. Falk, Prateek Sharma
Introduction Data on time trends of dysplasia and esophageal adenocarcinoma (EAC) in Barrett’s esophagus (BE) during the index endoscopy (ie, prevalent cases) are limited. Our aim was to determine the prevalence patterns of BE associated dysplasia on index endoscopy over the past 25 years. Methods The Barrett’s esophagus study is a multicenter outcome project of a large cohort of BE patients. Proportion of patients with index endoscopy findings of no dysplasia (NDBE), low-grade dysplasia (LGD), high-grade dysplasia (HGD), and esophageal adenocarcinoma (EAC) were extracted per year of index endoscopy, and 5-yearly patient cohorts were tabulated over years 1990 to 2010+ (2010-current). Prevalent dysplasia and endoscopic findings were trended over the past 25 years using percentage dysplasia (LGD, HGD, EAC, and HGD/EAC) to assess changes in detection of BE associated dysplasia over the last 25 years. Statistical analysis was done using software SAS version 9.4 (Cary, NC). Results A total of 3643 patients were included in the analysis with index endoscopy showing: NDBE in 2513 (70.1%), LGD in 412 (11.5%), HGD in 193 (5.4%), and EAC in 181 (5.1%). Over time, there was an increase in the mean age of BE patients (51.7 ± 29 years vs 62.6 ± 11.3 years) and proportion of males (84 % vs 92.6%) diagnosed with BE but a decrease in the mean BE length (4.4±4.3 cm vs 2.9±3.0 cm) as time progressed (1990-1994 to 2010-2016 time periods). Presence of LGD on index endoscopy remained stable over years 1990 to 2016. However, a significant increase (148% in HGD and 112% in EAC) in the diagnosis of HGD, EAC, and HGD/EAC were noted on index endoscopy over last 25 years (p<0.001) . There was also a significant increase in the detection of visible lesions on index endoscopy (1990-1994: 5.1% to 2005-2009: 6.3% and 2010+:16.3%) during the same period. Conclusion Our results suggest that the prevalence of HGD and EAC has significantly increased over the past 25 years despite a decrease in BE length during the same period. This rise parallels an increase in the detection of visible lesions, suggesting that a careful examination at the index examination is crucial.
Automated polyp detection in the colorectum: a prospective study (with videos) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-17 Peter Klare, Christoph Sander, Martin Prinzen, Bernhard Haller, Sebastian Nowack, Mohamed Abdelhafez, Alexander Poszler, Hayley Brown, Dirk Wilhelm, Roland M. Schmid, Stefan von Delius, Thomas Wittenberg
Background and Aims Adenoma detection is a highly personalized task that differs markedly between endoscopists. Technical advances are therefore desirable for the improvement of the adenoma detection rate (ADR). An automated computer driven technology would offer the chance to objectively assess the presence of colorectal polyps during colonoscopy. We present here the application of a real-time automatic polyp detection software (APDS) under routine colonoscopy conditions. Methods This was a prospective study at a university hospital in Germany. A prototype of a novel APDS software (“KoloPol,” Fraunhofer IIS Erlangen, Germany) was used for automated image-based polyp detection. The software functions by highlighting structures of possible polyp-lesions in a color-coded manner during real time colonoscopy procedures. Testing the feasibility of APDS deployment under real time conditions was the primary goal of the study. APDS polyp detection rates were defined as secondary endpoints provided that endoscopists’ detection served as criterion standard. Results APDS was applied in 55 routine colonoscopies without the occurrence of any clinically relevant adverse events. Endoscopists’ polyp and adenoma detection rates were 56.4% and 30.9%. APDS polyp and adenoma detection rates were 50.9% and 29.1%. APDS detected 55 out of a total of 73 polyps (75.3%). Smaller polyp size and flat polyp morphology were correlated with insufficient polyp detection by APDS. Conclusion Computer-assisted automated low-delay polyp detection is feasible during real-time colonoscopy. Efforts should be undertaken in order to improve APDS with respect to smaller and flat shaped polyps.
Outcome of endoscopic mucosal resection in Barrett’s esophagus determined by systematic quantification of epithelial glands using volumetric laser endomicroscopy Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-16 Amrit K. Kamboj, Allon Kahn, Tarek Sawas, Lori Lutzke, Prasad G. Iyer, Kenneth K. Wang, Cadman L. Leggett
Background Dysplastic Barrett’s esophagus (BE) lesions ≤2 cm in size can be targeted for en-bloc endoscopic mucosal resection (EMR). White-light endoscopy can underestimate the size of a lesion, limiting complete resection. Volumetric laser endomicroscopy (VLE) provides high-resolution cross-sectional imaging of BE. Epithelial glands are a VLE feature associated with BE dysplasia. We study the association between VLE gland quantification and outcome of resection. Methods Endoscopic mucosal resection (EMR) specimens of BE lesions targeted for en-bloc resection were imaged with VLE using an established protocol. Manual and automated quantification of epithelial glands was performed blinded to resection outcome. The presence of epithelial glands at the resection margins was recorded. Histologic en-bloc (R0) resection of the targeted lesion was defined by the absence and incomplete (R1) resection by the presence of dysplasia/neoplasia at specimen margins. Results Thirty-seven EMRs with a mean (SD) size of 1.04 (0.37) cm were imaged with VLE. The highest grade of dysplasia was low-grade dysplasia (N=12), high-grade dysplasia (N=19), and intramucosal cancer (N=6). The en-bloc resection rate was 37.8% (R0: N=14; R1: N=23). The mean (SD) number of epithelial glands quantified with VLE was 13.0 (6.7) and 28.8 (23.9) for R0 and R1 specimens respectively, with a significant mean difference of 15.8 glands (95% CI, 2–29, p=0.02). The presence of glands at the specimen margin was associated with incomplete resection (p<0.001). Conclusion Systematic quantification of BE epithelial glands using VLE can determine the outcome of endoscopic resection. Volumetric laser endomicroscopy may have a potential role in lesion margin assessment.
Clear liquid diet before bowel preparation predicts successful chromoendoscopy in patients with inflammatory bowel disease Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-16 Bryant Megna, Jennifer Weiss, Dana Ley, Sumona Saha, Patrick Pfau, Ian Grimes, Zhanhai Li, Freddy Caldera
Background and Aims Chromoendoscopy (CE) has been shown to generate both a superior diagnostic yield and dysplasia detection rate than conventional white-light endoscopy and requires a high-quality bowel preparation. The aim of this study was to identify predictors of the ability to perform CE in patients with inflammatory bowel disease (IBD). Methods We performed an observational study of patients with IBD undergoing colorectal cancer surveillance examinations with CE. Same day colonoscopy surveys were used to collect patient and procedural variables. Multivariate logistical regression was used to establish odds ratios (OR) of successful completion of CE. Results Eighty-eight patients with IBD were enrolled. We found that patients that did not follow a clear liquid diet before colonoscopy had much lower odds of being able to undergo CE (OR, 0.106; 95% CI, 0.013-0.845; p<0.034). Further, we found that previously identified risk factors (older age, history of diabetes mellitus, the timing and split-dosing of preparation solution, and procedure time (AM or PM), chronic narcotic use, and history of constipation) for inadequate bowel preparation were not associated with the ability to perform CE. Conclusions Following a clear liquid diet the entire day before procedure was highly predictive of the ability to perform CE. However, established risk factors for inadequate bowel preparation did not inhibit the ability to perform CE in our population. Endoscopists performing CE should consider recommending patients to follow a clear liquid diet the entire day before their examination.
Pine-cone and villi patterns are endoscopic signs suggestive of ulcerative colitis–associated colorectal cancer and dysplasia Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-13 Takahide Shinagawa, Keisuke Hata, Teppei Morikawa, Hirotoshi Takiyama, Shigenobu Emoto, Koji Murono, Manabu Kaneko, Kazuhito Sasaki, Takeshi Nishikawa, Toshiaki Tanaka, Kazushige Kawai, Masashi Fukayama, Hiroaki Nozawa
Background and Aims The appropriate site for targeted biopsy during surveillance colonoscopy for ulcerative colitis (UC) is still unclear. We aimed to clarify key endoscopic findings suggestive of neoplastic lesions for targeted biopsy in UC. Methods First, we created 769 stereomicroscopic pictures (509 neoplastic, 260 non-neoplastic) mimicking magnifying colonoscopic images from surgically resected specimens, including areas surrounding 25 neoplastic lesions in 15 patients with colitis-associated cancer at a single referral center. Second, we validated the results by using 113 magnifying endoscopic images (64 neoplastic, 49 non-neoplastic) from 39 lesions in 26 patients. Two evaluators blinded to the pathological diagnosis, independently classified them according to Kudo’s pit pattern and surface morphology, such as pine-cone/villi patterns. The correlation between stereomicroscopic and pathological findings (neoplastic vs non-neoplastic) for each image was investigated. The interobserver agreement was assessed using kappa statistics. Results In stereomicroscopic analysis, neoplastic pit patterns (type III-V) were significantly correlated with the presence of neoplasia (sensitivity 77.4%, specificity 89.5%, kappa value 0.677). Pine-cone/villi patterns also showed high specificity (96.8%) but low sensitivity (21.4%, kappa value 0.625) for neoplasia. Endoscopic validation showed similar trends. A revision of the endoscopic findings of flat dysplasia with non-neoplastic pit patterns revealed that a reddish area may facilitate the identification of such lesions. Conclusions Targeted biopsies are recommended especially for lesions showing pine-cone/villi patterns in addition to neoplastic pit patterns. For flat “non-neoplastic pit patterns,” a reddish area may be an indication for a biopsy.
Virtual chromoendoscopy using optical enhancement improves the detection of Barrett’s esophagus–associated neoplasia Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-10-03 M.A. Everson, L.B. Lovat, D.G. Graham, P. Bassett, C. Magee, D. Alzoubaidi, J.O. Fernández-Sordo, R. Sweis, M.R. Banks, S. Wani, J.M. Esteban, K. Ragunath, R. Bisschops, R.J. Haidry
Background and Aims The Seattle protocol for endoscopic Barrett’s esophagus surveillance samples a small proportion of the mucosal surface area – risking a potentially high miss rate of early neoplastic lesions. We assess if the new iScan Optical Enhancement system (OE, Pentax) improves the detection of early BE associated neoplasia compared with high definition white light endoscopy (HD-WLE) in both expert and trainee endoscopists to target sampling of suspicious areas. Such a system may both improve early neoplasia detection and reduce the need for random biopsies. Methods 41 patients undergoing endoscopic BE surveillance from Jan 2016-Nov 2017 were recruited from 3 international referral centers. Matched still images in both HD-WLE (n=130) and iScan OE (n=132) were obtained from endoscopic examinations. Two experts, unblinded to the videos and histology, delineated known neoplasia, forming a consensus criterion standard. 7 expert and 7 trainee endoscopists marked one position per image where they would expect a target biopsy to identify dysplastic tissue. The same expert panel then reviewed magnification images and using a previously validated classification system attempted to classify mucosa as dysplastic or non-dysplastic based on the mucosal and vascular patterns observed on magnification endoscopy. Diagnostic accuracy, sensitivity, specificity, NPV, and PPV were calculated. Improvements in dysplasia detection in HD-WLE vs OE and interobserver agreement (IA) were assessed by multilevel logistic regression analysis and Krippendorff’s alpha, respectively. Improvements in diagnostic performance were expressed as an odds ratio between the odds of an improvement in OE, compared with the odds of an improvement in WLE Results Accuracy of neoplasia detection was significantly higher in all trainees using OE versus WLE (76% vs 63%) and in 6 experts (84% vs 77%). OE improved sensitivity of dysplasia detection compared with WLE in 6 trainees (81% vs 71%) and 5 experts (77% vs 67%). Specificity improved in 6 trainees using OE vs WLE (70% vs 55%) and in 5 experts (92% vs 86%). PPV improved in both an expert and trainee cohort but NPV only improved significantly in trainees. Using the MV classification and OE magnification endoscopy compared with HD-WLE, we demonstrated improvements in accuracy (79.9% vs 66.7%), sensitivity (86.3% vs 83.4%) and specificity (71.2% vs 53.6%) of dysplasia detection. PPV improved (62% to 76.6%), as did NPV (67.7% to 78.5%).Interobserver agreement also improved using OE from 0.30 to 0.55. Conclusion iScan OE may improve dysplasia detection on endoscopic imaging of BE, as well as the accuracy of histology prediction compared with HD-WLE, when using OE magnification endoscopy in conjunction with a simple classification system in both expert and non-expert endoscopists
Blue-light imaging compared with high-definition white light for real-time histology prediction of subcentimetric colorectal polyps: a prospective randomized study Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-28 Emanuele Rondonotti, Silvia Paggi, Arnaldo Amato, Giuseppe Mogavero, Alida Andrealli, Francesco Simone Conforti, Dario Conte, Giancarlo Spinzi, Franco Radaelli
Background and aims Blue light imaging (BLI) is a new chromoendoscopy technology, potentially useful for differentiating neoplastic from non-neoplastic lesions. Present study was aimed at comparing BLI with high-definition white light (HDWL) in the real-time histology prediction of subcentimetric (<10 mm) colonic polyps. Methods Consecutive outpatients undergoing colonoscopy with ELUXEO 7000 endoscopy platform and 760 series videocolonscopes (Fujifilm Co, Tokyo, Japan) having at least one polyp <10 mm, were randomized to BLI or HDWL for polyp characterization. The accuracy of high-confidence real-time histology prediction (adenoma vs. non-adenoma) by either BLI or HDWL for subcentrimentic (primary end-point) and diminutive (<5mm) polyps was calculated, along with sensitivity, specificity, positive and negative predictive values, with histopathology as the reference standard. Results A total of 483 polyps were detected in 245 randomized patients (125 and 120 in the BLI and HDWL arms, respectively); 358 were diminutive and 283 adenomas. Overall, 222 (85.7%) and 193 (86.1%) polyps were characterized with high-confidence by BLI and HDWL, respectively (p=0.887), with an overall accuracy of 92% and 84%, respectively (p=0.011). The accuracy was significantly higher by BLI than HDWL also for diminutive polyps (92% vs. 83%; p=0.008). When BLI was used, the negative predictive value for diminutive rectosigmoid polyps was 88% and the post-polypectomy surveillance interval was correctly attributed in 85.7% and 93.7% of patients, according to U.S. and European guidelines respectively. Conclusions The BLI was superior to HDWL for the real-time prediction of subcentimetric polyp histology. A BLI-dedicated classification might further improve the endoscopists’ performances.
Clinical disease activity and endoscopic severity correlate poorly in children newly diagnosed with Crohn’s Disease Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-28 Nicholas Carman, Diane Tomalty, Peter C. Church, David R. Mack, Eric I. Benchimol, Anthony R. Otley, Kevan Jacobson, Hien Q. Huynh, Jennifer C. DeBruyn, Wael El-Matary, Mary Sherlock, Johan Van Limbergen, Anne M. Griffiths, Thomas D. Walters
Background /Aims: Treatment goals in Crohn’s disease (CD) have evolved to target mucosal healing. There is now a drive to determine if non-invasive measures can adequately identify the attainment and persistence of this goal. Currently, data describing the relationship between clinical indices and endoscopic appearance in pediatric Crohn’s disease (CD) are sparse. Our aim was to compare endoscopic severity with the weighted Pediatric Crohn’s Disease Activity Index (wPCDAI) in children with newly diagnosed CD. Methods All children ≤17 years of age newly diagnosed with CD enrolled in an inception cohort at sites of the Canadian Children Inflammatory Bowel Disease Network (CIDsCaNN) were eligible. Clinical disease activity at presentation was evaluated by wPCDAI and conventional biochemical parameters. Severity of disease at ileocolonoscopy was assessed by the Simple Endoscopic Score for Crohn’s disease (SES-CD), with segmental subscores noted. We evaluated the association of SES-CD and disease activity markers using the Pearson test of correlation, the Spearman rank coefficient, and linear regression models. Results Two hundred eighty patients from 11 centers were included in the analysis. The median wPCDAI score was 60 (IQR 40 – 80; 53% severe). Median SES-CD was 16 (IQR 10 – 22; 51% severe). The wPCDAI correlated weakly with SES-CD (r = 0.39, p <0.001). Examination of the individual components that contribute to the wPCDAI demonstrated weak correlation with SES-CD for all items apart from stooling (moderate correlation, r = 0.50 p < 0.001). Routine blood tests did not correlate well with SES-CD. In regression models, variation in clinical symptoms accounted for most of the variation in both wPCDAI and SES-CD, with no additional benefit from routine blood tests. Conclusions In children with newly diagnosed CD, wPCDAI correlates poorly with endoscopic disease activity. As treatment paradigms evolve to target mucosal healing, clinical markers should not be used in isolation to determine disease activity.
G-EYE colonoscopy is superior to standard colonoscopy for increasing adenoma detection rate: an international randomized controlled trial (with videos) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-28 Haim Shirin, Beni Shpak, Julia Epshtein, John Gásdal Karstensen, Arthur Hoffman, Rogier de Ridder, Pier Alberto Testoni, Sauid Ishaq, Acquisition of data, D. Nageshwar Reddy, Seth A. Gross, Helmut Neumann, Martin Goetz, Dov Abramowich, Menachem Moshkowitz, Meir Mizrahi, Peter Vilmann, Johannes Wilhelm Rey, Ralf Kiesslich
Background Colorectal cancer (CRC) is largely preventable with routine screening and surveillance colonoscopy; however, interval cancers arising from precancerous lesions missed by standard colonoscopy (SC) still occur. Increased adenoma detection rate (ADR) has been found to be inversely associated with interval cancers. The G-EYE device comprises a reusable balloon integrated at the distal tip of a standard colonoscope, which flattens haustral folds, centralizes the colonoscope’s optics and reduces bowel slippage. The insufflated balloon also aims to enhance visualization of the colon during withdrawal, thereby increasing ADR. Methods In this randomized, controlled, international, multicenter study (11 centers), subjects (age ≥50) referred to colonoscopy for screening, surveillance, or due to changes in bowel habits, were randomized to undergo either balloon-assisted colonoscopy using an insufflated balloon during withdrawal or standard high-definition colonoscopy. Primary endpoint was ADR. Results One thousand subjects were enrolled between May 2014 and September 2016 to undergo colonoscopy by experienced endoscopists; 803 were finally analyzed (SC: n=396; balloon-assisted colonoscopy: n=407). Baseline parameters were similar in both groups. Balloon-assisted colonoscopy provided a 48.0% ADR compared with 37.5% in the SC group (28% increase, p=0.0027). Additionally, balloon-assisted colonoscopy provided for a significant increase in detection of advanced (p=0.0033), flat adenomas (p<0.0001), and sessile serrated adenoma/polyp (SSA/Ps) (p=0.0026). Conclusions Balloon-assisted colonoscopy yielded a higher ADR and increased the detection of advanced, flat and SSA/Ps when compared with SC. Improved detection by the G-EYE device could impact the quality of CRC screening by reducing miss rates, and consequently reducing of interval cancers incidence; clinicaltrials.gov (NCT01917513).
Quality of life and fear of cancer recurrence in T1 colorectal cancer patients treated with endoscopic or surgical tumor resection Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-28 H. Dang, W.H. de Vos tot Nederveen Cappel, S.M.S. van der Zwaan, M.E. van den Akker-van Marle, H.L. van Westreenen, Y. Backes, L.M.G. Moons, F.A. Holman, K.C.M.J. Peeters, J. van der Kraan, A.M.J. Langers, W.M. Lijfering, J.C.H. Hardwick, J.J. Boonstra
Background and Aims To optimize therapeutic decision-making in T1 colorectal cancer (T1 CRC) patients, it is important to elicit the patient’s perspective next to considering medical outcome. Because empirical data on patient-reported impact of different treatment options are lacking, we evaluated patients’ quality of life, perceived time to recovery and fear of cancer recurrence after endoscopic or surgical treatment for T1 CRC. Methods In this cross-sectional study, we selected patients with histologically confirmed T1 CRC, who participated in the Dutch Bowel Cancer Screening Programme and received endoscopic or surgical treatment between January 2014 and July 2017. Quality of life was measured using the EORTC QLQ-C30 and the EQ-5D-5L questionnaire. We used the Cancer Worry Scale (CWS) to evaluate patients’ fear of cancer recurrence. A question on perceived time to recovery after treatment was also included in the set of questionnaires sent to the patients. Results Of all 119 eligible patients, 92.4% responded to the questionnaire (endoscopy group: 55/62, surgery group: 55/57). Compared with the surgery group, perceived time to recovery was on average 3 months shorter in endoscopically treated patients after adjustment for confounders (19.9 days vs 111.3 days; p = 0.001). The 2 treatment groups were comparable with regard to global quality of life, functioning domains as well as symptom severity scores. Moreover, patients in the endoscopy group did not report more fear of cancer recurrence than those in the surgery group (CWS score range 0-40; endoscopy: 7.6 vs surgery: 9.7; p = 0.140). Conclusions From the patient’s perspective, endoscopic treatment provides a quicker recovery than surgery, without provoking more fear of cancer recurrence or any deterioration in quality of life. These results contribute to the shared therapeutic decision-making process of clinicians and T1 CRC patients.
Fully automated diagnostic system with artificial intelligence using endocytoscopy to identify the presence of histologic inflammation associated with ulcerative colitis (with video) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-27 Yasuharu Maeda, Shin-ei Kudo, Yuichi Mori, Masashi Misawa, Noriyuki Ogata, Seiko Sasanuma, Kunihiko Wakamura, Masahiro Oda, Kensaku Mori, Kazuo Ohtsuka
Background and Aims In the treatment of ulcerative colitis (UC), an incremental benefit of achieving histologic healing beyond that of endoscopic mucosal healing has been suggested; persistent histological inflammation increases the risk of exacerbation and dysplasia. However, identification of persistent histologic inflammation is extremely difficult using conventional endoscopy. Furthermore, the reproducibility of endoscopic disease activity is poor. We developed and evaluated a computer-aided diagnosis (CAD) system to predict persistent histological inflammation using endocytoscopy (520-fold ultra-magnifying endoscope). Methods We evaluated the accuracy of the CAD system using test image sets. First, we retrospectively reviewed the data of 187 patients with UC from whom biopsy samples were obtained after endocytoscopic observation. Endocytoscopy images and biopsy samples of each patient were collected from 6 colorectal segments: cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum. All endocytoscopy images were tagged with reference to the biopsy sample’s histological activity. For validation samples, 525 validation sets of 525 independent segments were collected from 100 patients, and 12,900 endocytoscopy images from the remaining 87 patients were used for machine learning to construct CAD. The primary outcome measure was the diagnostic ability of CAD to predict persistent histologic inflammation. Its reproducibility for all test images was also assessed. Results CAD provided diagnostic sensitivity, specificity, and accuracy as follows: 74% (95% confidence interval, 65%–81%), 97% (95%–99%), and 91% (83%–95%), respectively. Its reproducibility was perfect (κ = 1). Conclusions Our CAD system potentially allows fully automated identification of persistent histological inflammation associated with UC.
The relationship between the endoscopic withdrawal time and adenoma/polyp detection rate in individual colonic segments: a KASID multicenter study Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-26 Yunho Jung, Young-Eun Joo, Hyun Gun Kim, Seong Ran Jeon, Jae Myung Cha, Hyo-Joon Yang, Jong Wook Kim, Jun Lee, Kyeong Ok Kim, Hye Kyung Song, Young Hwangbo, Jeong Eun Shin
Background and aims The appropriate colonoscopy withdrawal times for individual colonic segments are not well known. The relationship between withdrawal time and adenoma/polyp detection rates in individual colonic segments was examined in this study. Methods This was a prospective observational study involving 724 patients who underwent colonoscopy screening or surveillance colonoscopy from October 2015 to February 2017 at 10 university hospitals. Results In the right segment of the colon, the adenoma detection rate (ADR) (33.2 vs 13.7%, p<0.001), polyp detection rate (PDR), serrated polyp detection rate (SDR), and number of adenomas per colonoscopy (APC) were significantly higher when the colonoscopy withdrawal time was ≥2 minutes compared with <2 minutes. When the withdrawal time was ≥4 minutes in the proximal colon and ≥3 minutes in the left segment of the colon, the ADR, PDR, and APC were significantly higher compared with withdrawal times of <4 minutes and <3 minutes, respectively. Multivariate analyses showed that the ADR was significantly associated with withdrawal times of ≥2 minutes in the right segment of the colon (OR, 2.98; 95% CI, 1.72–5.15; p<0.001), ≥4 minutes in the proximal colon (OR, 4.48; 95% CI, 3.15–6.36; p<0.001), and ≥3 minutes in the left segment of the colon (OR, 2.92; 95% CI, 1.74–4.91; p<0.001). Conclusions The polyp and adenoma detection rates appeared to be significantly increased when the withdrawal time was ≥2 minutes in the right colon segment, ≥4 minutes in the proximal colon, and ≥3 minutes in the left colon segment compared with shorter withdrawal times.
Endoscopic magnet placement into sub-adventitial tunnels for augmenting lower esophageal sphincter using submucosal endoscopy: ex vivo and in vivo study in a porcine model (with video) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-24 Akira Dobashi, Shu-Wei Wu, Jodie L. Deters, Charles A. Miller, Mary A. Knipschield, Graham P. Cameron, Lichun Lu, Elizabeth Rajan, Christopher J. Gostout
Background and Aims Endolumenal therapies serve as a treatment option for gastroesophageal reflux disease (GERD). This study aimed to determine if magnets could be placed endoscopically using the adventitial layer creating a sub-adventitial space near the esophagogastric junction to augment the lower esophageal sphincter using the submucosal endoscopy. Methods This study consisted of 2 phases, ex vivo and in vivo, with domestic pig esophagus. A long submucosal tunnel was made at mid to lower esophagus. The muscularis propria was incised by a needle knife within the submucosal tunnel. A sub-adventitial tunnel was made by biliary balloon catheter blunt dissection, and a magnet was deployed in the sub-adventitial space. The same maneuver was done within the opposing esophageal wall, with magnet placement in the opposing sub-adventitial space. Results Submucosal tunnels and sub-adventitial tunnels were successful without perforation in ex vivo in all attempts and nine of ten cases, respectively. Magnets were deployed in the sub-adventitial space in seven cases. Magnets connected and separated with atraumatic endoscope passage into the stomach and re-connected when the endoscope was withdrawn under fluoroscopy in 5 of the 7 cases (71.4%). In vivo submucosal tunnels and sub-adventitial tunnels were successful in all 5 cases, and magnet augmentation was functionally active in 4 cases (80%). Conclusion Sub-adventitial tunnels were feasible and could represent a new working space for endoscopic treatment. Endoscopic placement of magnets within the sub-adventitial space may be an attractive alternative endolumenal therapy for GERD.
Quality assurance of colonoscopy within the Dutch national colorectal cancer screening program Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-18 Maxime E.S. Bronzwaer, Annekatrien C.T.M. Depla, Niels van Lelyveld, Marcel B.W. Spanier, Yvonne H. Oosterhout, Monique E. van Leerdam, Manon C.W. Spaander, Evelien Dekker, , M. van Haastert, J.J. Keller, A.D. Koch, J.J. Koornstra, M.C.A. van Kouwen, A. Masclee, M.W. Mundt, R.J. de Ridder, A. van der Sluys-Veer, M. van Wieren
Colorectal cancer (CRC) screening is capable of reducing CRC-related morbidity and mortality. Colonoscopy is the reference standard to detect CRC, also providing the opportunity to detect and resect its precursor lesions; colorectal polyps. Therefore, colonoscopy is either used as a primary screening tool or as a subsequent procedure after a positive triage test in screening programs based on non-invasive stool testing or sigmoidoscopy. However, in both settings, colonoscopy is not fully protective for the occurrence of post-colonoscopy CRCs (PCCRCs). Because the majority of PCCRCs are the result of colonoscopy-related factors, a high-quality procedure is of paramount importance to assure optimal effectiveness of CRC screening programs. For this reason, at the start of the Dutch fecal immunochemical test (FIT)-based screening program, quality criteria for endoscopists performing colonoscopies in FIT-positive screenees, as well as for endoscopy centers, were defined. In conjunction, an accreditation and auditing system was designed and implemented. In this report we describe the quality assurance process for endoscopists participating in the Dutch national CRC Screening Program, including a detailed description of the evidence-based quality criteria. We believe that our experience might serve as an example for colonoscopy quality assurance programs in other CRC screening programs.
Annular pancreas: endoscopic and pancreatographic findings from a tertiary referral ERCP center Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-18 Mark A. Gromski, Glen A. Lehman, Nicholas J. Zyromski, James L. Watkins, Ihab I. El Hajj, Damien Tan, Lee McHenry, Jeffrey J. Easler, Temel Tirkes, Stuart Sherman, Evan L. Fogel
Background and Aims Annular pancreas is a congenital anomaly where pancreatic tissue encircles the duodenum. Current knowledge of endoscopic findings of annular pancreas is limited to small case series. The aim of this study is to describe the endoscopic and pancreatographic findings of patients with annular pancreas at a large tertiary care ERCP center. Methods This is a retrospective observational study. Our IRB approved, prospectively collected ERCP database was queried for cases of annular pancreas. The electronic medical record was searched for patient and procedure-related data. Results From January 1, 1994 to December 31, 2016, 46 patients with annular pancreas underwent ERCP at our institution. Index ERCP was technically successful in 42 patients (91.3%) and technical success was achieved in all 46 patients (100%) after 2 attempts, when required. A duodenal narrowing or ring was found in the majority of patients (n=39, 84.8%), yet only 2 (4.3%) had retained gastric contents. Pancreas divisum was found in 21 patients (45.7%), 18 of which were complete divisum. Pancreatobiliary neoplasia was the indication of ERCP in 7 patients (15.2%). Pancreatographic findings consistent with chronic pancreatitis were noted in 15 patients (32.6%) at the index ERCP. Conclusion This is the largest series describing the endoscopic and pancreatographic findings of patients with annular pancreas. We found that 45.7% of patients had concurrent pancreas divisum. Endoscopic therapy was successful in the vast majority of patients at our institution after one ERCP, and in all patients after a second ERCP. Nearly one-third of patients had findings consistent with chronic pancreatitis at the time of index ERCP. It is unclear whether this may be a feature of the natural history of annular pancreas.
Phase I Study of EUS-guided Photodynamic Therapy for Locally Advanced Pancreatic Cancer Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-14 John M. DeWitt, Kumar Sandrasegaran, Bert O'Neil, Michael G. House, Nicholas J. Zyromski, Amikar Sehdev, Susan M. Perkins, Janet Flynn, Lynne McCranor, Safi Shahda
Background and Aims Locally advanced pancreatic cancer (LAPC) has a poor prognosis. There are limited data describing the use of photodynamic therapy (PDT) for pancreatic cancer in humans. We hypothesized that EUS-guided PDT for LAPC is safe, technically feasible and produces a dose- and time-dependent increasing degree of image-defined tumor necrosis. Methods In a single center, prospective, dose escalation phase I study, patients with treatment-naïve LAPC received intravenous (IV) porfimer sodium (Concordia Laboratories Inc; St Michael, Barbados) followed 2 days later by EUS-PDT. EUS-PDT was performed by puncture with a 19-gauge needle and insertion of a 1.0 cm light diffuser (Pioneer Optics, Bloomfield, Conn) and illumination with a 630-nm light (Diomed Inc., Andover, Mass). CT scan 18 days after PDT was done to assess for change in pancreatic necrosis. Nab-Paclitaxel (125 mg/ m2 IV) and Gemcitabine (1000 mg /m2 IV) were initiated 7 days after CT and given weekly for 3/4 weeks (1 cycle) until disease progression or unacceptable toxicity. Results Twelve patients (mean age: 67 ± 6 years; 8 male) with tumors (mean diameter: 45.2 ± 12.9 mm) in the head and/or neck (8) or body and/or tail (4) underwent EUS-PDT. Compared with baseline imaging, increased volume and percent of tumor necrosis was observed in 6 of 12 (50%) after EUS-PDT. Mean overall increase in volume and percent necrosis were 10 ± 26 cm3 (p=0.20) and 18% ± 22% (p=0.016), respectively. After a median follow-up of 10.5 months (range: 1.0-37.4), median progression-free (PFS) and overall survival (OS) were 2.6 months (95% CI, 0.7, not estimable) and 11.5 months (95% CI, 1.1, 16.9), respectively. Surgical resection was attempted in 2 and pathology showed a complete response (n=1) and residual 2 mm tumor (n=1). There were 8 serious adverse events and none related to EUS or EUS-PDT. Conclusion EUS-PDT for LAPC appears to be safe and produces measurable imaged-defined tumor necrosis. Phase II studies are warranted.
Increasing adenoma detection rates in the right side of the colon comparing retroflexion or a second forward view: a systematic review Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-14 Madhav Desai, Mohammad Bilal, Nour Hamade, Venkata Subhash Gorrepati, Viveksandeep Thogulva Chandrasekar, Ramprasad Jegadeesan, Neil Gupta, Pradeep Bhandari, Alessandro Repici, Cesare Hassan, Prateek Sharma
Background and Aims Right-sided lesions are often missed during standard colonoscopy (SC). A second forward view examination or retroflexion in the right side of the colon, have both been proposed as techniques to improve ADR in the right side of the colon. Comparative data of examining the right side of the colon with a second forward view or retroflexion is not known in a pooled analysis. We performed a systematic review of the literature to assess the yield of a second forward view compared with retroflexion examination for the detection of right-sided adenomas. Methods A systematic literature search was performed using the following databases: Pubmed, Embase, Web of science, and Cochrane. Only full-length published articles that provided information on adenoma detection and miss rate during either a second forward view or retroflexed view of the right side of the colon after the initial standard forward withdrawal (SC) were included. The following outcomes were assessed: adenoma miss rate (AMR) comparison of second forward view versus retroflexion after SC, AMR of SC compared with second forward view, AMR of SC compared with retroflexion and right-sided adenoma detection of the second forward view and retroflexion. Pooled rates were reported as risk difference or odds ratio (OR) with 95% confidence intervals (CI) with a p-value <0.05 for statistical significance. Statistical analysis was performed with Review Manager v5.3. Results A total of 4 studies with 1882 patients were found eligible who underwent a second forward view of the right side of the colon after the initial SC. The average age of patients was 58.3 years. Data on right-side ADR were available from all 4 studies for the second forward view; however, only 2 incorporated studies provided information on right-sided ADR with retroflexion. Pooled estimate of AMR of a single SC was 13.3% (95% CI, 6.6%-20%) when compared with a second forward view examination (n=4), whereas it was 8.1% (3.7-12.5%) when compared with a retroflexion examination (n=3). However, when the second forward view was compared with retroflexion in terms of AMR from an analysis of 3 eligible studies, there was no statistically significant difference found (7.3% vs 6.3%; pooled OR, 1.2; 95% CI, 0.9-1.61; p=0.21). The second forward view of the right side of the colon increased the right-side ADR by 10% (n=4; second forward view vs SC: 33.6% vs 26.7%) with a pooled risk difference: 0.09 (95% CI, 0.03-0.15; p<0.01). Retroflexion increased the right-side ADR by 6% (n=3, RF vs SC: 28.4% vs 22.7%) with a pooled risk difference: 0.06 (95% CI, 0.03-0.09; p<0.01). Conclusion After standard colonoscopy withdrawal, both a second forward view and retroflexed view of the right side of the colon are associated with improvement in ADR. Either one of these techniques should be considered during standard colonoscopy to increase ADR and to improve the quality of colonoscopy.
Clinical and endoscopic predictors for intraprocedural mucosal injury during per-oral endoscopic myotomy Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-13 Yun Wang, Zu-Qiang Liu, Mei-Dong Xu, Shi-Yao Chen, Yun-Shi Zhong, Yi-Qun Zhang, Wei-Feng Chen, Wen-Zheng Qin, Jian-Wei Hu, Ming-Yan Cai, Li-Qing Yao, Ping-Hong Zhou, Quan-Lin Li
Background & Aims Mucosal injury (MI) is one of the most common perioperative adverse events of per-oral endoscopic myotomy (POEM). Severe undertreated MI may lead to contamination of the tunnel and even mediastinitis. This study explored the characteristics, predictors and management approaches of intraoperative MI. Methods A retrospective review of the prospectively collected database at a large tertiary referral endoscopy unit was conducted for all patients undergoing POEM between August 2010 and March 2016. MI was graded according to the difficulty of repair (I, easy to repair; II, difficult to repair). The primary outcomes were the incidence and predictors of intraoperative MI. Secondary outcomes were MI details and the corresponding treatment. Results POEM was successfully performed in 1912 patients. A total of 338 patients experienced 387 MIs, for an overall frequency of 17.7% (338/1912). Type II MI was rare, with a frequency of 1.7% (39/1912). Major adverse events were common in patients with MI than in those without MI (6.2% vs 2.5%, P<0.001). On multivariable analysis, MI was independently associated with previous Heller myotomy (odds ratio [OR] 2.094, P=0.026), previous POEM (OR 2.441, P=0.033), submucosal fibrosis (OR 4.530, P<0.001), mucosal edema (OR 1.834, P=0.001) and tunnel length ≥13 cm (OR 2.699, P<0.001). Previous POEM (OR 5.005, P=0.030) and submucosal fibrosis (OR 12.074, P<0.001) were significant predictors of type II MI. POEM experience>1 year was a protective factor for MI (OR 0.614, P=0.042) and type II MI (OR 0.297, P=0.042). Conclusions MI during POEM is common, but type II injury is rare. Previous POEM and submucosal fibrosis were significant predictors of Type II mucosal injury. POEM experience after the learning curve reduces the risk of MI.
A randomized-controlled trial evaluating general endotracheal anesthesia versus monitored anesthesia care and the incidence of sedation-related adverse events during ERCP in high-risk patients Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-11 Zachary L. Smith, Daniel K. Mullady, Gabriel D. Lang, Koushik K. Das, Robert M. Hovis, Riddhi S. Patel, Thomas G. Hollander, Jeffery Elsner, Catherine Ifune, Vladimir M. Kushnir
Background and Aims ERCP is a complex procedure and often performed in patients at high risk for sedation-related adverse events (SRAE). However, there is no current standard of care with regard to mode of sedation and airway management during ERCP. The aim of this study was to assess the safety of general endotracheal anesthesia (GEA) versus propofol-based monitored anesthesia care without endotracheal intubation (MAC) in patients undergoing ERCP at high risk for SRAE. Methods Consecutive patients undergoing ERCP at high risk for SRAE at a single center were invited to participate in this randomized-controlled trial (NCT02850887) comparing GEA and MAC. Inclusion criteria were: STOP-BANG score of ≥3, abdominal ascites, body mass index (BMI) ≥35, chronic lung disease, ASA class >3, Mallampati class 4 airway, moderate to heavy alcohol use. Exclusion criteria were preceding EUS, emergent ERCP, tracheostomy, unstable airway, gastric outlet obstruction or delayed gastric emptying, and altered foregut anatomy. The primary endpoint was composite incidence of SRAE: (hypoxemia, use of airway maneuvers, hypotension requiring vasopressors, sedation-related procedure interruption, cardiac arrhythmia, and respiratory failure. Secondary outcomes included procedure duration, cannulation success, in-room time and immediate adverse events. Results Two hundred patients (mean age 61.1±13.6 years, 36.5% female) were randomly assigned to GEA (n=101) or MAC (n=99). Composite SRAE were significantly higher in the MAC group compared with GEA (51.5% vs 9.9%, p<0.001). This was primarily driven by the frequent need for airway maneuvers in the MAC group. Additionally, ERCP was interrupted in 10.1% of patients in the MAC group in order to convert to GEA due to respiratory instability refractory to airway maneuvers (n=8) or significant retained gastric contents (n=2). There were no statistically significant differences in cannulation, in-room, procedure or fluoroscopy times between the two groups. All patients undergoing GEA were successfully extubated in the procedure room at completion of ERCP and Aldrete scores in recovery did not differ between the two groups. There were no immediate adverse events. Conclusion In patients at high risk for SRAE undergoing ERCP, sedation with GEA is associated with a significantly lower incidence of SRAE, without impacting procedure duration, success, recovery, or in-room time. These data suggest that GEA should be used for ERCP in patients at high risk for sedation-related adverse events; www.clinicaltrials.gov, (NCT02850887).
EUS-guided cholecystostomy versus endoscopic transpapillary cholecystostomy for acute cholecystitis in high-risk surgical patients Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-10 Dongwook Oh, Tae Jun Song, Dong Hui Cho, Do Hyun Park, Dong-Wan Seo, Sung Koo Lee, Myung-Hwan Kim, Sang Soo Lee
Background and Aims Endoscopic gallbladder drainage (GBD) has been performed as an alternative to percutaneous drainage for acute cholecystitis. To date, there has been no comparative study between endoscopic ultrasound-guided cholecystostomy (EUSC) and endoscopic transpapillary cholecystostomy (ETC). The aim of this study was to compare the outcomes of EUSC and ETC. Methods Retrospective review of an endoscopic GBD database prospectively collected at the Asan Medical Center (between July 2010 and December 2014) was performed to identify consecutive patients with acute cholecystitis who underwent attempted endoscopic GBD. Procedural and long-term outcomes were evaluated using inverse probability of treatment weighting (IPTW). Results A total of 172 patients (76 in the EUSC group and 96 in the ETC group) were included in this study. Seven patients who failed to undergo ETC crossed over to the EUSC group. After adjustment with IPTW method, technical success (99.3% vs 86.6%, P < 0.01) and clinical success rates (99.3% vs 86%, P < 0.01) was significantly higher in the EUSC group than in the ETC group. The procedure-related adverse event rate was significantly higher in the ETC group (7.1% vs 19.3%, P = 0.02). The cholecystitis or cholangitis recurrence rate (12.4% vs 3.2%) was also higher in the ETC group than in the EUSC group, as identified using Cox analysis (hazard ratio, 3.01; 95% confidence interval, 0.73 - 12.9; P = 0.04). Conclusions In patients with acute cholecystitis and unfit for surgery, EUSC may be a more suitable treatment method than ETC.
Impact of preoperative biopsy on severe submucosal fibrosis on endoscopic submucosal dissection for colorectal laterally spreading tumors: a propensity score analysis Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-08 Shusei Fukunaga, Yasuaki Nagami, Masatsugu Shiba, Taishi Sakai, Hirotsugu Maruyama, Masaki Ominami, Koji Otani, Shuhei Hosomi, Fumio Tanaka, Koichi Taira, Tetsuya Tanigawa, Hirokazu Yamagami, Toshio Watanabe, Yasuhiro Fujiwara
Background and Aims It is thought that preoperative biopsy for superficial-type colorectal tumors should be avoided because submucosal fibrosis caused by biopsy makes endoscopic mucosal resection impossible. However, few studies have reported the influence of biopsy on colorectal endoscopic submucosal dissection (ESD). This study aimed to examine the effect of biopsy on submucosal fibrosis and treatment outcomes of ESD for laterally spreading tumors (LSTs). Methods Between April 2005 and September 2015, 441 consecutive patients underwent colorectal ESD in Osaka City University Hospital. Using propensity score matching and inverse probability of treatment weighting (IPTW), we retrospectively evaluated risk factors for severe submucosal fibrosis and treatment outcomes for patients with LST, with or without preoperative biopsy. Results A total of 428 LSTs resected using ESD were enrolled. After matching, there were 136 matched pairs of lesions that did or did not receive biopsies. Preoperative biopsy increased severe fibrosis compared to that in the non-biopsy group (20.6% versus 11.0 %; p = 0.03) and was significantly associated with severe fibrosis after matching (odds ratio [OR], 2.09; 95% confidence interval [CI], 1.07–4.10; p = 0.03). After adjustment with IPTW, biopsy also increased the risk of severe fibrosis (OR, 2.33; 95% CI, 1.17–4.63; p = 0.02). However, no significant differences were observed between the two groups in treatment outcomes. Conclusions Preoperative biopsy for colorectal LSTs might cause severe submucosal fibrosis, but has no adverse influence on clinical outcomes of ESD.
The utility of rapid on-site evaluation of touch imprint cytology from endoscopic and cholangioscopic forceps biopsy (with video) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-05 Saeed Ali, Robert H. Hawes, Kambiz Kadkhodayan, Ehsan Rafiq, Udayakumar Navaneethan, Ji Y. Bang, Shyam Varadarajulu, Muhammad K. Hasan
Background and Aims Rapid on-site evaluation of touch imprint cytology (ROSE-TIC) is a simple and rapid method used for the diagnosis of benign and malignant lesions. We evaluated the diagnostic accuracy of ROSE-TIC for advanced intestinal luminal and indeterminate pancreatobiliary lesions during endoscopy. Methods This is a retrospective descriptive study of patients who underwent endoscopy or ERCP between January 1, 2014, and December 31, 2016. It included patients who were referred for the treatment of intestinal luminal lesions or evaluation of indeterminate pancreatobiliary lesions. The slides were prepared by gently touching the specimen onto a glass slide and were examined under the microscope. The main outcome measure was to determine the diagnostic accuracy of ROSE-TIC by comparing the onsite cytology findings with the corresponding off-site histological diagnosis. Results All 222 (106 pancreatobiliary and 116 GI lesions) patients had a prior benign diagnosis of intestinal luminal lesions or indeterminate diagnosis of pancreatobiliary lesions. The overall sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and diagnostic accuracy of ROSE-TIC were 97%, 85%, 83%, 97.2%, and 90%, respectively. The accuracy varied with the site of the biopsy. The accuracy was lowest for upper GI tract where it was 85.2%, whereas it was 95% for lower GI tract lesions. Conclusion By establishing a rapid onsite diagnosis ROSE-TIC expedites decision on patient management. Prospective studies are needed to confirm these preliminary findings.
Blue laser imaging-bright improves real-time detection rate of early gastric cancer: a randomized controlled study Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-04 Osamu Dohi, Nobuaki Yagi, Yuji Naito, Akifumi Fukui, Yasuyuki Gen, Naoto Iwai, Tomohiro Ueda, Naohisa Yoshida, Kazuhiro Kamada, Kazuhiko Uchiyama, Tomohisa Takagi, Hideyuki Konishi, Akio Yanagisawa, Yoshito Itoh
Background and Aims Blue laser imaging (BLI)-bright (BLI-bright) has shown promise as a more useful tool for detection of early gastric cancer (EGC) than white-light imaging (WLI). However, the diagnostic performance of BLI-bright in the detection of EGC has not been investigated. We aimed to compare real-time detection rates of WLI with that of BLI-bright for EGC. Methods This was a prospective, randomized, controlled study in 2 Japanese academic centers. We investigated 629 patients undergoing follow-up endoscopy for atrophic gastritis with intestinal metaplasia or surveillance after endoscopic resection of EGC. Patients were randomly assigned to receive primary WLI followed by BLI-bright or primary BLI-bright followed by WLI. The real-time detection rates of EGC were compared between primary WLI and primary BLI-bright. Results Of 298 patients in each group, the real-time detection rate of EGC with primary BLI-bright was significantly greater than that with primary WLI (93.1% vs 50.0%; p = 0.001). Primary BLI-bright had a significantly greater ability to detect EGCs in patients with a history of endoscopic resection for EGC, an HP-negative stomach after eradication therapy, lesions with an open-type atrophic border, lesions in the lower third of the stomach, depressed-type lesions, small lesions measuring <10 mm and 10 to 20 mm in diameter, reddish lesions, well-differentiated adenocarcinomas, and lesions with a depth of invasion of T1a. Conclusions BLI-bright has a higher real-time EGC detection rate than WLI. BLI-bright should be performed during surveillance endoscopy in patients at high risk for EGC.
Single-stage EUS-guided choledochoduodenostomy using a lumen-apposing metal stent for malignant distal biliary obstruction Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-04 Andrea Anderloni, Alessandro Fugazza, Edoardo Troncone, Francesco Auriemma, Silvia Carrara, Rossella Semeraro, Roberta Maselli, Milena di Leo, Ferdinando D’Amico, Amrita Sethi, Alessandro Repici
Background and Aims EUS-guided choledochoduodenostomy(EUS-CD) using a lumen-apposing metal stent (LAMS) has been recently reported as an alternative treatment approach for patients with malignant obstructive jaundice and failed endoscopic retrograde cholangiopancreatography (ERCP). We analyzed the safety, technical and clinical efficacy of EUS-CD using LAMS in patients with malignant obstructive jaundice. Methods Retrospective study of consecutive patients with inoperable malignant distal bile duct obstruction who underwent EUS-CD using an electrocautery enhanced(EC)- LAMS over a 3-year (2015-2018) period. The main outcome measures were: technical and clinical success (defined as a decline in serum bilirubin by 50% at 2-week follow-up). Secondary outcomes were: occurrence of adverse events, procedure time, and stent patency. Results Forty-six patients (47.8 % females; median age 73.1 ± 12.6) underwent direct EUS-CD using the biliary EC-LAMS. The procedure was technically successful in 43 patients (93.5%). The rate of clinical success was 97.7%. Adverse events occurred in 5 (11.6%) patients and included the following: 1 fatal bleeding 17 days after stent placement, 3 episodes of stent occlusion (food impaction), and 1 spontaneous migration (all 4 requiring reintervention). The mean follow-up was 114.37 days (CI, 73.2-155.4). Conclusions EUS-CD using the EC-LAMS is effective. The rate of adverse events including one fatal event is not negligible and should be carefully considered before using the stent in this clinical setting. Prospective studies are required to validate our preliminary findings to fully assess the long-term efficacy and safety of the stent.
EUS-guided drainage in the management of postoperative pancreatic leaks and fistulas (with video) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-09-01 Christian Jürgensen, Marius Distler, Alexander Arlt, Stefan Brückner, Mark Ellrichmann, Katja Matthes, Marleen Ludwig, Stephan Sulk, Laura Romberg, Sebastian Zeissig, Clemens Schafmayer, Sebastian Hinz, Thilo Welsch, Marcus Bahra, Heiko Aselmann, Jürgen Weitz, Fritz Klein, Thomas Becker, Jochen Hampe
Background and Aims Postoperative pancreatic leakage and fistulae (jointly referred as POPF) are a leading adverse event after partial pancreatic resection. Treatment algorithms are currently not standardized. Evidence regarding the role of endoscopy is scarce. Methods One hundred ninety-six POPF patients with (N=132) and without (N=64) concomitant pancreatic fluid collections (PFC) from centers in Berlin, Kiel, and Dresden were analyzed retrospectively. Clinical resolution was used as the primary endpoint of analysis. Results Analysis was stratified by the presence or absence of a PFC as these patients differ in treatment pathway and the presence of systemic inflammation with a median CRP of 30.7 mg/dL in patients without a PFC versus 131.0 mg/dL in patients with a PFC (p=3.4×10-4). In patients with PFCs, EUS-guided intervention lead to resolution in a median of 8 days as compared with 25 days for percutaneous drainage and 248 days for surgery (p=3.75×10-14). There was a trend toward a higher success rate of EUS-guided intervention as a primary treatment modality with 85% (p=0.034), followed by percutaneous drainage (64%) and surgery (41%). When applied as a rescue intervention (N=24), EUS lead to clinical resolution in 96% of cases. In patients without PFCs, EUS-guided internalization in a novel endoscopic technique lead to resolution after a median of 4 days as compared with 51 days for a remaining surgical drainage (p=9.3×10-9). Conclusions In this retrospective analysis, EUS guided drainage of POPF lead to more rapid resolution. EUS may be considered as a viable option in the management of PFCs and POPF and should be evaluated in prospective studies.
Pancreatoscopy-guided laser dissection and ablation for treatment of benign and neoplastic pancreatic disorders: an initial report (with videos) Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-08-31 Chetan Mittal, Raj J. Shah
Background and Aims Per-oral pancreatoscopy (POP) permits direct evaluation of the pancreatic duct for the visualization and sampling of neoplastic lesions, and treatment of pancreatic duct stones using intraductal lithotripsy techniques. Pancreatic laser endotherapy of mucosa has been described in animal models for tumor ablation but human experience is lacking. We describe 3 unique and challenging clinical situations that benefited from pancreatic laser dissection and ablation. Methods This was a retrospective case series. Results Case 1 was a 75-year-old female with presumed divisum-associated chronic pancreatitis who had recurrent acute pancreatitis despite minor papilla sphincterotomy and therapeutic stent placement. POP showed a side-branch IPMN within the neck of the pancreas. POP-guided holmium laser ablation of neoplastic tissue was performed followed by pancreatic stent placement every 6 months with no further hospitalizations at 20 months of follow-up. Case 2 was a 69-year-old female with divisum-associated chronic calcific pancreatitis and recalcitrant mid-body stenosis. Previous attempts at balloon dilation and stent placement failed to resolve the stenosis. POP-guided holmium laser dissection of the stenosis was pursued with immediate radiographic resolution. Case 3 was a 65-year-old female with chronic calcific pancreatitis and large stone burden who underwent POP-guided electrohydraulic lithotripsy and partial stone extraction followed by stent placement. Unfortunately, the stent fractured during the subsequent removal attempt as the fragment was impacted in the pancreatic body. POP-guided laser dissection and lithotripsy was used to debulk dense fibrous tissue and stones surrounding the stent fragment, respectively, followed by removal. Conclusions Pancreatoscopy-guided laser endotherapy is a novel and potentially useful technique to manage difficult benign and neoplastic pancreatic disorders.
Technical feasibility and oncological safety of diagnostic endoscopic resection for superficial esophageal cancer Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-05-08 Masashi Takeuchi, Koichi Suda, Yasuo Hamamoto, Motohiko Kato, Shuhei Mayanagi, Kayo Yoshida, Kazumasa Fukuda, Rieko Nakamura, Norihito Wada, Hirofumi Kawakubo, Hiroya Takeuchi, Naohisa Yahagi, Yuko Kitagawa
BackgroundActive use of endoscopic resection (ER) for cM3-SM2 esophageal cancer may enable sufficient extent of esophageal resection and help determine the need for lymph node dissection based on histopathological findings. However, ER preceding esophagectomy may have an adverse impact on outcomes. This study was designed to determine the technical feasibility and oncological safety of diagnostic ER.MethodsA single-institution retrospective cohort study was performed between July 2008 and June 2014. During this period, 135 consecutive patients with clinical T1a-M3N0M0, T1b-SM1N0M0, and T1b-SM2N0M0 primary esophageal cancer were referred to our division. Eight patients who underwent chemoradiothearpy as primary treatment were excluded because of inadequate pathological findings. Based on oncological and physical factors, we categorized the remaining 127 patients into two groups: primary esophagectomy (n=54) and primary ER (n=73).ResultsIn all 127 patients, the 3-year overall survival (OS) and disease-free survival (DFS) rates were 95.7% and 87.6%, respectively. No adverse event requiring surgical intervention was observed after ER. Diagnostic ER had no negative impact on surgical outcomes, DFS, and OS after esophagectomy. Fourteen patients (19.2%) of those who received primary ER underwent curative resection, whereas 11 (20.4%) who had pT1a disease, no lymphovascular invasion, and no pathological lymph node metastasis underwent primary esophagectomy.ConclusionsDiagnostic ER for cM3-SM2 esophageal cancer with or without subsequent esophagectomy was feasible and safe from not only surgical but also oncological perspective. Approximately 20% of cM3-SM2N0M0 patients can potentially avoid undergoing additional treatment including esophagectomy using diagnostic ER.
A novel submucosal injection solution for endoscopic resection of large colorectal lesions: a randomized, double-blind trial Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-05-08 Alessandro Repici, Michael Wallace, Prateek Sharma, Pradeep Bhandari, Gianluca Lollo, Roberta Maselli, Cesare Hassan, Douglas K. Rex
BackgroundSIC-8000 (Eleview) is a new FDA-approved solution for submucosal injection developed to provide long-lasting cushion to facilitate endoscopic resection maneuvers. Our aim was to compare the efficacy and safety of SIC-8000 with those of saline solution, when performing endoscopic mucosal resection (EMR) of large colorectal lesions.MethodsIn a randomized double-blind trial, patients undergoing EMR for ≥20 mm colorectal non-pedunculated lesions were randomized in a 1:1 ratio between SIC-8000 and saline solution as control solution in 5 tertiary centers. Endoscopists and patients were blinded to the type of submucosal solution used. Total volume to complete EMR and per lesion size and time of resection were primary end-points, whereas the Sydney Resection Quotient (SRQ), as well as other EMR outcomes, and the rate of adverse events were secondary. A 30-day telephone follow up was performed. An alpha level <0.05 was considered as statistically significant (NCT 02654418).ResultsOf the 327 patients screened, 226 (mean age: 66±10; males: 56%) were enrolled in the study and randomized between the 2 submucosal agents. Of these, 211 patients (mean size of the lesions 33±13 mm; I-s: 36%; proximal colon: 74%) entered in the final analysis (SIC-8000: 102; saline solution: 109). EMR was complete in all cases. The total volume needed for EMR was significantly less in the SIC-8000 arm compared with saline solution (16.1±9.8 mL vs 31.6±32.0 mL; p<0.001). This corresponded to an average volume per lesion size of 0.5±0.3 mL/mm and 0.9±0.6 mL/mm with SIC-8000 and saline solution, respectively, (p<0.001). The mean time to completely resect the lesion tended to be lower with SIC-8000 as compared with saline solution (19.1±16.8 minutes vs 29.7±68.9 minutes; p=0.1). The SRQ was significantly higher with SIC-8000 as compared with saline solution (10.3±8.1 vs 8.0±5.7; p=0.04) with a trend for a lower number of resected pieces (5.7±6.0 vs 6.5±5.04; p=0.052) and a higher rate of en bloc resections (19/102, 18.6% vs 12/111, 11.0%; p=0.1). The rate of adverse events was similar between the 2 arms (SIC-8000: 18.6%, saline solution: 17%), and none of the serious adverse events (SIC-8000: 8.8%; saline solution: 10.7%) was related with study treatment.ConclusionsIn a double-blind, randomized clinical trial, a new FDA approved agent for sub-mucosal injection appeared to be a more effective and equally safe submucosal agent for EMR injection than saline solution.
Comparison of endoscopic submucosal dissection and surgery for superficial esophageal squamous cell carcinoma: A propensity score-matched analysis Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-05-08 Yang Won Min, Hyuk Lee, Byeong Geun Song, Byung-Hoon Min, Hong Kwan Kim, Yong Soo Choi, Jun Haeng Lee, Na-Young Hwang, Keumhee C. Carriere, Poong-Lyul Rhee, Jae J. Kim, Jae Ill Zo, Young Mog Shim
Background and AimsEndoscopic submucosal dissection (ESD) has been widely accepted for treating superficial esophageal squamous cell carcinoma (SESCC). However, long-term outcomes of ESD and esophagectomy for SESCC have not been compared. We compared the clinical outcomes of ESD and esophagectomy in a matched cohort.MethodsPatients who underwent ESD and esophagectomy for SESCC were included. We selected SESCCs without obvious submucosal invasion from the surgical database by reviewing endoscopic images. To minimize the effect of selection bias, propensity score matching was performed. Overall survival (OS), disease-specific survival (DSS), recurrence-free survival (RFS), and metachronous RFS were compared between the 2 groups. Adverse event rates were also compared.ResultsIn a matched cohort of 120 pairs, OS, DSS, and RFS were comparable between the 2 groups. The 5-year OS, DSS, and RFS rates were 93.9% versus 91.2%, 100% versus 97.4%, and 92.8% versus 95.3% for the ESD and esophagectomy groups, respectively. The metachronous RFS was worse in the ESD group than in the esophagectomy group (P = .004). The 5-year metachronous RFS rates were 90.3% versus 100% for the ESD and esophagectomy groups, respectively. The esophagectomy group showed a higher overall adverse event rate than the ESD group (55.5% vs 18.5%, P < .0001). In each subgroup of mucosal and submucosal cancer, OS, DSS, and RFS were also comparable between the 2 groups.ConclusionsESD provides long-term outcomes comparable to esophagectomy in patients with SESCC without endoscopic evidence of obvious submucosal invasion. ESD should be considered as the first-line treatment for these patients.
Liquid nitrogen spray cryotherapy for dysphagia palliation in patients with inoperable esophageal cancer Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-05-08 Toufic Kachaamy, Ravi Prakash, Madappa Kundranda, Raman Batish, Jeffrey Weber, Scott Hendrickson, Leon Yoder, Hannah Do, Theresa Magat, Rajeev Nayar, Digant Gupta, Trisha DaSilva, Ashish Sangal, Shivangi Kothari, Vivek Kaul, Pankaj Vashi
Background and AimsDysphagia is a debilitating symptom in patients with inoperable esophageal cancer contributing to poor quality of life and worsening nutritional status. The 2 most commonly used palliative modalities for dysphagia are radiation therapy (RT) and esophageal stent placement. However, RT is limited by adverse events (AEs) and total dose, and stent placement has a high rate of AEs including reflux, migration, and chest pain. A relatively new modality of liquid nitrogen endoscopic spray cryotherapy has been described as salvage when other options have been exhausted and when patients are no longer receiving systemic therapy. We evaluated the safety and efficacy of cryotherapy as the primary modality for relieving dysphagia in inoperable esophageal cancer including patients receiving systemic cancer therapy.MethodsThis is a retrospective multicenter consecutive case series of 49 inoperable esophageal cancer patients undergoing palliative endoscopic cryotherapy at 4 specialized cancer centers from May 2014 to May 2016. The primary outcomes were change in dysphagia scores between pre- and post-cryotherapy and AE. Dysphagia was measured using a 4-point Likert scale: 0, no dysphagia; 1, dysphagia to solids; 2, dysphagia to semi-solids; 3, dysphagia to liquids; 4, dysphagia to saliva.ResultsThere were 39 males and 10 females with a mean age of 58 years who underwent a total of 120 cryotherapy treatments. The mean dysphagia score improved significantly from 2.4 pre-cryotherapy to 1.7 post-cryotherapy (improvement of 0.7 points; p<0.001). Minor AE were seen in 6/120 (5.0%) cryotherapy treatments (1 intra-procedural and 5 post-procedural). In addition, one patient developed a severe intra-procedural AE of dilation-related perforation whereas another patient developed a benign stricture requiring dilation.ConclusionsThis preliminary retrospective study suggests that liquid nitrogen spray cryotherapy may be safe and effective for dysphagia palliation in inoperable esophageal cancer. Large prospective studies are needed to confirm these findings and identify patient and procedure characteristics associated with the greatest benefit.
An international, multicenter, comparative trial of EUS-guided gastrogastrostomy-assisted ERCP versus enteroscopy-assisted ERCP in patients with Roux-en-Y gastric bypass anatomy Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-05-03 Majidah Bukhari, Thomas Kowalski, Jose Nieto, Rastislav Kunda, Nitin K. Ahuja, Shayan Irani, Apeksha Shah, David Loren, Olaya Brewer, Omid Sanaei, Lea Fayad, Yen-I. Chen, Saowanee Ngamruengphong, Vivek Kumbhari, Vikesh Singh, Hanaa Dakour Aridi, Mouen A. Khashab
Background & AimsERCP is challenging in patients with Roux-en-Y gastric bypass (RYGB) anatomy. EUS-guided gastrogastrostomy (GG) creation is a promising novel technique to access the excluded stomach in order to facilitate conventional ERCP. We aimed to compare procedural outcomes and adverse events (AEs) between EUS-guided gastrogastrostomy-assisted ERCP (EUS-GG-ERCP) and enteroscopy assisted ERCP (e-ERCP) in patients with RYGB.MethodsPatients with RYGB anatomy who underwent EUS-GG-ERCP or e-ERCP between 2014 and 2016 at 5 tertiary centers were included. The primary outcome was technical success of ERCP, defined as successful cannulation of the selected duct with successful intervention as intended. Secondary outcomes included (1) total procedural time (in the EUS-GG group, total procedural time included EUS-GG creation plus ERCP procedure time); (2) length of hospital stay; and (3) rate/severity of AEs graded according to the ASGE lexicon.ResultsA total of 60 patients (mean age 57.2 ±13.2, 75% female) were included, of whom 30 (50%) underwent EUS-GG-ERCP and 30 (50%) underwent e-ERCP (DBE-ERCP 19 and SBE-ERCP 11). The technical success rate was significantly higher in the EUS-GG-ERCP versus the e-ERCP group (100% vs 60.0%, p <0.001). Total procedure time was significantly shorter in patients who underwent EUS-GG-ERCP (49.8 min vs 90.7 min, p<0.001). Postprocedure median length of hospitalization was shorter in the EUS-GG group (1 vs 10.5 days, p=0.02). Rate of AEs was similar in both groups (10% vs 6.7%, p=1).ConclusionEUS-GG-ERCP may be superior to e-ERCP in patients with RYGB anatomy in terms of a higher technical success and shorter procedural times and offers a similar safety profile.
EUS-Guided Hepaticoenterostomy as a portal to allow definitive antegrade treatment of benign biliary diseases in patients with surgically altered anatomy Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-05-03 Theodore W. James, Y. Claire Fan, Todd H. Baron
Background & AimsEUS-guided hepaticoenterostomy (EUS-HE) is usually reserved for palliation of malignant biliary obstruction after failed endoscopic retrograde cholangiography (ERC) or inaccessible biliary tree in surgically altered anatomy (SAA). We describe outcome of EUS-HE and antegrade therapy for benign biliary disease in patients with SAA.MethodsRetrospective review of 20 consecutive patients with surgically altered anatomy and benign biliary obstruction who underwent EUS-HE performed by one endoscopist at a tertiary center over a three-year period.ResultsDuring the study period, 37 patients underwent EUS-HE, 24 for benign disease. Of these, 20 patients had SAA and were analyzed (15 females, mean age, 62 years). SAA consisted of 9 Roux-en-Y Gastric Bypass, 6 Roux-en-Y Hepaticojejunostomy, 2 Billroth II, and 3 Whipple. Indications for ERC were common bile duct stone (8), benign postsurgical stricture (7), chronic pancreatitis (3), inflammatory stricture (1) and treatment of bile leak (1). Five patients had previously failed balloon enteroscopy-assisted ERC. The approach was transgastric in 15 and transjejunal in 5. In all cases a branch of the left hepatic duct with a mean diameter of 7.8 mm was accessed. Median stent length was 80 mm with diameters of 8 or 10 mm. Antegrade, definitive endoscopic therapy via the HE was performed in 18 patients with an average of 2.7 procedures performed for resolution of stones and/or downstream strictures. HE stents were removed in 17 patients after a mean of 91 days without adverse events. Three patients experienced mild adverse events (one with postprocedural pancreatitis after placement of a 10F transpapillary stent, one with postprocedural abdominal pain, and one with postprocedural cholangitis) requiring hospitalization for less than 3 nights; no severe adverse events occurred. Average postprocedural hospital stay was 1.3 days. No deaths occurred during follow-up.ConclusionsEUS-guided hepaticoenterostomy is safe and effective in the management of benign biliary obstruction in patients with surgically-altered anatomy. It creates a portal to allow definitive, antegrade therapy and is a viable alternative to other endoscopic methods in this patient population.
A phase III study evaluating the efficacy and safety of remimazolam (CNS 7056) compared with placebo and midazolam in patients undergoing colonoscopy Gastrointest. Endosc. (IF 7.204) Pub Date : 2018-04-30 Douglas K. Rex, Raj Bhandari, Taddese Desta, Michael DeMicco, Cynthia Schaeffer, Kyle Etzkorn, Charles Barish, Ronald Pruitt, Brooks D. Cash, Daniel Quirk, Felix Tiongco, Shelby Sullivan, David Bernstein
BackgroundRemimazolam is an ultrashort-acting benzodiazepine.MethodsWe performed a randomized double-blind comparison of remimazolam to placebo for outpatient colonoscopy. This study design was a requirement of the U.S. Food and Drug Administration. An additional group was randomized to open-label midazolam administered according to its package insert instructions (randomization ratio for remimazolam:placebo:midazolam was 30:6:10). Study medications were administered under the supervision of the endoscopist, without any involvement of an anesthesia specialist. Patients were given 50 to 75 μg of fentanyl before receiving study medications. Patients who failed to achieve adequate sedation in any arm were rescued with midazolam dosed at the investigator’s discretion. The primary endpoint was a composite that required 3 criteria be met: completion of the colonoscopy, no need for rescue medication, and ≤5 doses of remimazolam or placebo in any 15-minute interval (≤3 doses of midazolam in any 12-minute interval in the open-label midazolam arm).ResultsThere were 461 randomized patients in 12 U.S. sites. The primary endpoint was met for remimazolam, placebo, and midazolam in 91.3%, 1.7%, and 25.2% of patients, respectively (P< 0.0001 for remimazolam vs placebo). Patients administered remimazolam received less fentanyl, had faster recovery of neuropsychiatric function, were ready for discharge faster, and felt back to normal faster than patients with both placebo and midazolam. Hypotension was less frequent with remimazolam and hypoxia occurred in 1% of subjects with remimazolam or midazolam. There were no treatment-emergent serious adverse events.ConclusionRemimazolam can be safely administered under the supervision of endoscopists for outpatient colonoscopy and allows faster recovery of neuropsychiatric function compared with placebo (midazolam rescue) and midazolam.
Transplantation of autologous esophageal mucosa to prevent stricture after circumferential endoscopic submucosal dissection of early esophageal cancer (with video) Gastrointest. Endosc. (IF 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
Backgroud and study aimsEsophageal stricture is a common adverse event after endoscopic submucosal dissection (ESD) when it involves entire circumference of esophagus. We aimed to assess the effectiveness and safety of endoscopic transplantation of autologous esophageal mucosa in preventing stricture formation after circumferential ESD.Patients and methodsNine patients who underwent circumferential ESD for early esophageal cancer were enrolled. After undergoing ESD, autologous esophageal mucosal patches were attached to the “ulcer surface” using hemoclips and then fixed with a covered metal mesh stent. The stent was removed 7 days after the procedure. The patients were followed up with endoscopy at scheduled times.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) after the procedure. The median number of endoscopic balloon dilatation (EBD) 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 cESD.
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