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Clark D Hair,1 Divyesh V Sejpal21Department of Medicine, Section of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, TX, USA; 2Department of Medicine, Section of Gastroenterology, Hofstra North Shore-LIJ School of Medicine, North Shore University Hospital, Manhasset, NY, USAAbstract: Biliary stenting has evolved dramatically over the past 30 years. Advancements in stent design have led to prolonged patency and improved efficacy. However, biliary stenting is still affected by occlusion, migration, anatomical difficulties, and the need for repeat procedures. Multiple novel plastic biliary stent designs have recently been introduced with the primary goals of reduced migration and improved ease of placement. Self-expandable bioabsorbable stents are currently being investigated in animal models. Although not US Food and Drug Administration approved for benign disease, fully covered self-expandable metal stents are increasingly being used in a variety of benign biliary conditions. In malignant disease, developments are being made to improve ease of placement and stent patency for both hilar and distal biliary strictures. The purpose of this review is to describe recent developments and future directions of biliary stenting.Keywords: plastic stents, self-expandable metal stents, drug eluting stents, bioabsorbable stents, malignant biliary strictures, benign biliary strictures

Volumetric laser endomicroscopy (VLE) uses optical coherence tomography (OCT) for real-time, microscopic cross-sectional imaging. A US-based multi-center registry was constructed to prospectively collect data on patients undergoing upper endoscopy during which a VLE scan was performed. The objective of this registry was to determine usage patterns of VLE in clinical practice and to estimate quantitative and qualitative performance metrics as they are applied to Barrett's esophagus (BE) management. All procedures utilized the NvisionVLE Imaging System (NinePoint Medical, Bedford, MA) which was used by investigators to identify the tissue types present, along with focal areas of concern. Following the VLE procedure, investigators were asked to answer six key questions regarding how VLE impacted each case. Statistical analyses including neoplasia diagnostic yield improvement using VLE was performed. One thousand patients were enrolled across 18 US trial sites from August 2014 through April 2016. In patients with previously diagnosed or suspected BE (894/1000), investigators used VLE and identified areas of concern not seen on white light endoscopy (WLE) in 59% of the procedures. VLE imaging also guided tissue acquisition and treatment in 71% and 54% of procedures, respectively. VLE as an adjunct modality improved the neoplasia diagnostic yield by 55% beyond the standard of care practice. In patients with no prior history of therapy, and without visual findings from other technologies, VLE-guided tissue acquisition increased neoplasia detection over random biopsies by 700%. Registry investigators reported that VLE improved the BE management process when used as an adjunct tissue acquisition and treatment guidance tool. The ability of VLE to image large segments of the esophagus with microscopic cross-sectional detail may provide additional benefits including higher yield biopsies and more efficient tissue acquisition. Clinicaltrials.gov NCT02215291.

Background and study aims  Optical coherence tomography (OCT) is a new technology available for evaluation of indeterminate biliary strictures. It allows under-the-surface visualization and preliminary studies have confirmed standardized characteristics associated with malignancy. The aim of this study is to evaluate the first interobserver agreement in identifying previously agreed upon OCT criteria and diagnosing of malignant versus benign disease. Patients and methods  Fourteen endoscopists were asked to review an atlas of reference clips and images of eight criteria derived from expert consensus A total of 35 de-identified video clips were then evaluated for presence of the eight criteria and for final diagnosis of malignant versus benign using the atlas as reference Intraclass correlation (ICC) analysis was done to evaluate interrater agreement. Results  Clips of 23 malignant lesions and 12 benign lesions were scored. Excellent interobserver agreement was seen with dilated hypo-reflective structures (0.85) and layering effacement (0.89); hyper-glandular mucosa (0.76), intact layering (0.81), and onion-skin layering (0.77); fair agreement was seen with scalloping (0.58), and thickened epithelium (0.4); poor agreement was seen with hyper-reflective surface (0.36). The diagnostic ICC for both neoplastic (0.8) and non-neoplastic (0.8) was excellent interobserver agreement. The overall diagnostic accuracy was 51 %, ranging from 43 % to 60 %. Conclusions  Biliary OCT is a promising new modality for evaluation of indeterminate biliary strictures. Interobserver agreement ranged from fair to almost perfect on eight previously identified criteria. Interobserver agreement for malignancy diagnosis was substantial (0.8). Further studies are needed to validate this data., Competing Interests: Competing interests Amy Tyberg: Consultant for Ninepoint Medical, Endogastric Solutions, Obalon Therapeutics. Avik Sarkar has done consulting work for US Endoscopy and Obalon Therapeutics. Haroon Shahid has done consulting work for US Endoscopy. Michel Kahaleh has received grants support from Boston Scientific, Fujinon, W.L. Gore, Apollo Endosurgery, Cook Endoscopy, GI Dynamics, Merit Medical, Interscope Med, Olympus, ERBE, and MI Tech. He is a consultant for Boston Scientific and Laboratories Inc., ABBvie. None of those funding was related to this paper., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background and Aims: Direct endoscopic necrosectomy (DEN) of walled-off pancreatic necrosis (WOPN) lacks dedicated instruments and requires repetitive and cumbersome procedures. This study evaluated the safety and efficacy of a new powered endoscopic debridement (PED) system designed to simultaneously resect and remove solid debris within WOPN., Methods: This was a single-arm, prospective, multicenter, international device trial conducted from November 2018 to August 2019 at 10 sites. Patients with WOPN ≥6 cm and ≤22 cm and with >30% solid debris were enrolled. The primary endpoint was safety through 21 days after the last DEN procedure. Efficacy outcomes included clearance of necrosis, procedural time, adequacy of debridement, number of procedures until resolution, hospital stay duration, and quality of life., Results: Thirty patients (mean age, 55 years; 60% men) underwent DEN with no device-related adverse events. Of 30 patients, 15 (50%) achieved complete debridement in 1 session and 20 (67%) achieved complete debridement within 2 or fewer sessions. A median of 1.5 interventions (range, 1-7) were required. Median hospital stay was 10 days (interquartile range, 22). There was an overall reduction of 91% in percent necrosis within WOPN from baseline to follow-up and 85% in collection volume. Baseline WOPN volume was positively correlated with the total number of interventions (ρ = .363, P = .049)., Conclusions: The new PED system seems to be a safe and effective treatment tool for WOPN, resulting in fewer interventions and lower hospital duration when compared with published data on using conventional instruments. Randomized controlled trials comparing the PED system with conventional DEN are needed. (Clinical trial registration number: NCT03694210.)., (Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Visual characteristics seen during digital single-operator cholangioscopy (DSOC) have not been validated. The aim of this 2-phase study was to define terminology by consensus for the visual diagnosis of biliary lesions to develop a model for optimization of the diagnostic performance of DSOC., Materials and Methods: In phase 1 (criteria identification), video-cholangioscopy clips were reviewed by 12 expert biliary endoscopists, who were blinded to the final diagnosis. Visual criteria were consolidated into the following categories: (1) stricture, (2) lesion, (3) mucosal features, (4) papillary projections, (5) ulceration, (6) abnormal vessels, (7) scarring, (8) pronounced pit pattern.During the second phase (validation), 14 expert endoscopists reviewed DSOC (SpyGlass DS, Boston Scientific) clips using the 8 criteria to assess interobserver agreement (IOA) rate., Results: In phase 1, consensus for visual findings were categorized into 8 criteria titled the "Monaco Classification." The frequency of criteria were: (1) presence of stricture-75%, (2) presence of lesion type-55%, (3) mucosal features-55%, (4) papillary projections-45%, (5) ulceration-42.5%, (6) abnormal vessels-10%, (7) scarring-40%, and (8) pronounced pit pattern-10%. The accuracy on final diagnosis based on visual impression alone was 70%.In phase 2, the IOA rate using Monaco Classification criteria ranged from slight to fair. The presumptive diagnosis IOA was fair (κ=0.31, SE=0.02), and overall diagnostic accuracy was 70%., Conclusions: The Monaco classification identifies 8 visual criteria for biliary lesions on single-operator digital cholangioscopy. Using the criteria, the IOA and diagnostic accuracy rate of DSOC is improved compared with prior studies., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Background and Aims: Expert endoscopists previously reported ERCP outcomes for the first commercialized single-use duodenoscope. We aimed to document usability of this device by endoscopists with different levels of ERCP experience., Methods: Fourteen "expert" (>2000 lifetime ERCPs) and 5 "less-expert" endoscopists performed consecutive ERCPs in patients without altered pancreaticobiliary anatomy. Outcomes included ERCP completion for the intended indication, rate of crossover to another endoscope, device performance ratings, and serious adverse events., Results: Two hundred ERCPs including 81 (40.5%) with high complexity (American Society for Gastrointestinal Endoscopy grades 3-4) were performed. Crossover rate (11.3% vs 2.5%, P = .131), ERCP completion rate (regardless of crossovers) (96.3% vs 97.5%, P = .999), median ERCP completion time (25.0 vs 28.5 minutes, P = .130), mean cannulation attempts (2.8 vs 2.8, P = .954), and median overall satisfaction with the single-use duodenoscope (8.0 vs 8.0 [range, 1.0-10.0], P = .840) were similar for expert versus less-expert endoscopists, respectively. The same metrics were similar by procedural complexity except for shorter median completion time for grades 1 to 2 versus grades 3 to 4 (P < .001). Serious adverse events were reported in 13 patients (6.5%)., Conclusions: In consecutive ERCPs including high complexity procedures, endoscopists with varying ERCP experience had good procedural success and reported high device performance ratings. (Clinical trial registration number: NCT04223830.)., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and study aims  En bloc endoscopic mucosal resection (EMR) is preferred over piecemeal resection for polyps ≤ 20 mm. Data on colorectal EMR training are limited. We aimed to evaluate the en bloc EMR rate of polyps ≤ 20 mm among advanced endoscopy trainees and to identify predictors of failed en bloc EMR. Methods  This was a multicenter prospective study evaluating trainee performance in EMR during advanced endoscopy fellowship. A logistic regression model was used to identify the number of procedures and lesion cut-off size associated with an en bloc EMR rate of ≥ 80 %. Multivariate analysis was performed to identify predictors of failed en bloc EMR. Results  Six trainees from six centers performed 189 colorectal EMRs, of which 104 (55 %) were for polyps ≤ 20 mm. Of these, 57.7 % (60/104) were resected en bloc. Trainees with ≥ 30 EMRs (OR 6.80; 95 % CI: 2.80-16.50; P  = 0.00001) and lesions ≤ 17 mm (OR 4.56;95 CI:1.23-16.88; P  = 0.02) were more likely to be associated with an en bloc EMR rate of ≥ 80 %. Independent predictors of failed en bloc EMR on multivariate analysis included: larger polyp size (OR:6.83;95 % CI:2.55-18.4; P  = 0.0001), right colon location (OR:7.15; 95 % CI:1.31-38.9; P  = 0.02), increased procedural difficulty (OR 2.99; 95 % CI:1.13-7.91; P  = 0.03), and having performed < 30 EMRs (OR: 4.87; 95 %CI: 1.05-22.61; P  = 0.04). Conclusions  In this pilot study, we demonstrated that a relatively low proportion of trainees achieved en bloc EMR for polyps ≤ 20 mm and identified procedure volume and lesion size thresholds for successful en bloc EMR and independent predictors for failed en bloc resection. These preliminary results support the need for future efforts to define EMR procedure competence thresholds during training., Competing Interests: Competing interests Dr. Yang is a consultant for Boston Scientific, Lumendi, and Steris Endoscopy. Dr. Draganov is a consultant for Boston Scientific, Olympus America, Cook Medical, Microtech, Steris Endoscopy, Merit, Lumendi, and Fujifilm. Dr. Wallace is a consultant for Virgo Inc, Cosmo/Aries Pharmaceuticals, Anx Robotica (2019), Covidien, GI Supply, Endokey, Endostart, Microtech, and Boston Scientific; has stock options with Virgo Inc; and receives research grants from Fujifilm, Boston Scientific, Olympus America, Medtronic, Ninepoint Medical, and Cosmo/Aries Pharmaceuticals. Dr. Gomez is a consultant for Olympus America. Dr. Bucobo is a consultant for Cook Medical. Dr. Trindade is a consultant for Pentax Medical and Olympus America and receives research support from Ninepoint Medical. Dr. Kumta is a consultant for Apollo Endosurgery, Boston Scientific, Gyrus ACMI Inc, GLG consulting, and Olympus. Dr. DiMaio is a consultant and teacher for Boston Scientific and Medtronic and a speaker for AbbVie. Dr. Pohl receives research grants from Steris and Cosmo/Aries Pharmaceuticals., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background and Aims: Patients with primary sclerosing cholangitis (PSC) and dominant biliary strictures carry increased risk for the development of cholangiocarcinoma. Although ERCP-based techniques including brush cytology and intraductal biopsy sampling represent first-line tissue sampling methods for dominant strictures, sensitivity is low. Probe-based confocal laser endomicroscopy (pCLE) offers microscopic-level imaging of subepithelial biliary mucosa. Because data regarding the use of pCLE in PSC are limited, we aimed to investigate its diagnostic performance in dominant strictures., Methods: This was a multicenter prospective study involving PSC patients with dominant strictures. ERCP with pCLE was performed with use of the Miami classification (2+ criteria for malignant diagnosis) and Paris classification. Final malignant diagnoses required histopathologic confirmation, and benign diagnoses required a minimum of 1 year of follow-up without development of cancer., Results: Fifty-nine patients (mean age, 49 years; 59% men) with 63 strictures were included in the study. Stricture locations included the common bile duct (31.7%), bifurcation (22.2%), and common hepatic duct (19%). Seven patients (11.9%) were found to have cholangiocarcinoma. The sensitivity and specificity of pCLE was 85.7% (95% confidence interval [CI], 42.1-99.6) and 73.1% (95% CI, 58.9-84.4), respectively. Within specific stricture locations, the highest sensitivity was seen at the bifurcation (100%; 95% CI, 2.5-100) and the right hepatic duct (100%; 95% CI, 29.2-100). The lowest sensitivities were seen at the common bile duct (25%; 95% CI, 5.5-57.2) and the left hepatic duct (28.6%; 95% CI, 3.7-70.9)., Conclusions: In this prospective multicenter study, pCLE had a high sensitivity in detecting cholangiocarcinoma, but technical aspects of the probe may limit evaluation in the common bile duct and left hepatic duct. Further evaluation is needed to elucidate the role of pCLE in the algorithm of excluding neoplasia in biliary strictures associated with PSC. (Clinical trial registration number: NCT02736708.)., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and study aims  There are conflicting data regarding the risk of post-ERCP pancreatitis (PEP) with self-expandable metallic stents (SEMS) compared to polyethylene stents (PS) in malignant biliary obstructions and limited data related to benign obstructions. Patients and methods  A retrospective cohort study was performed of 1136 patients who underwent ERCP for biliary obstruction and received SEMS or PS at a tertiary-care medical center between January 2011 and October 2016. We evaluated the association between stent type (SEMS vs PS) and PEP in malignant and benign biliary obstructions. Results  Among the 1136 patients included in our study, 399 had SEMS placed and 737 had PS placed. Patients with PS were more likely to have pancreatic duct cannulation, pancreatic duct stent placement, double guidewire technique, sphincterotomy and sphincteroplasty as compared to the SEMS group. On multivariate analysis, PEP rates were higher in the SEMS group (8.0 %) versus the PS group (4.8 %) (OR 2.27 [CI, 1.22, 4.24]) for all obstructions. For malignant obstructions, PEP rates were 7.8 % and 6.6 % for SEMS and plastic stents, respectively (OR 1.54 [CI, 0.72, 3.30]). For benign obstructions the PEP rate was higher in the SEMS group (8.8 %) compared to the PS group (4.2 %) (OR 3.67 [CI, 1.50, 8.97]). No significant differences between PEP severity were identified based on stent type when stratified based on benign and malignant. Conclusions  PEP rates were higher when SEMS were used for benign obstruction as compared to PS. For malignant obstruction, no difference was identified in PEP rates with use of SEMS vs PS., Competing Interests: Competing interests Divyesh V. Sejpal – Consulting for Boston Scientific and Olympus Arvind J. Trindade – Consulting for Olympus and Pentax, (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background and Aims: Data on colorectal EMR (C-EMR) training are lacking. We aimed to evaluate C-EMR training among advanced endoscopy fellows (AEFs) by using a standardized assessment tool (STAT)., Methods: This multicenter prospective study used a STAT to grade AEF training in C-EMR during their 12-month fellowship. Cumulative sum analysis was used to establish learning curves and competence for cognitive and technical components of C-EMR and overall performance. Sensitivity analysis was performed by varying failure rates. AEFs completed a self-assessment questionnaire to assess their comfort level with performing C-EMR at the completion of their fellowship., Results: Six AEFs (189 C-EMRs; mean per AEF, 31.5 ± 18.5) were included. Mean polyp size was 24.3 ± 12.6 mm, and mean procedure time was 22.6 ± 16.1 minutes. Learning curve analyses revealed that less than 50% of AEFs achieved competence for key cognitive and technical C-EMR endpoints. All 6 AEFs reported feeling comfortable performing C-EMR independently at the end of their training, although only 2 of them achieved competence in their overall performance. The minimum threshold to achieve competence in these 2 AEFs was 25 C-EMRs., Conclusions: A relatively low proportion of AEFs achieved competence on key cognitive and technical aspects of C-EMR during their 12-month fellowship. The relatively low number of C-EMRs performed by AEFs may be insufficient to achieve competence, in spite of their self-reported readiness for independent practice. These pilot data serve as an initial framework for competence threshold, and suggest the need for validated tools for formal C-EMR training assessment., (Copyright © 2021. Published by Elsevier Inc.)

Purpose of Review: Indeterminate biliary strictures (IDBS) continue to be an area of frustration for clinicians. Standard endoscopic retrograde cholangiopancreatography (ERCP) with conventional brush cytology and/or forceps biopsy has a low sensitivity for distinguishing benign from malignant biliary strictures. A delay in diagnosis of malignancy has consequences for subsequent therapy or surgery. In this article, we review current and emerging technologies that may aid in this diagnostic dilemma., Recent Findings: Several technologies have been utilized in IDBS to establish a diagnosis which include peroral cholangioscopy, confocal laser endomicroscopy, endoscopic ultrasound with fine needle aspiration, intraductal ultrasound, optical coherence tomography, fluorescence in situ hybridization, next generation sequencing, integrated molecular pathology, and DNA-image cytometry. While cholangioscopy and confocal laser endomicroscopy have become standards of care in expert centers for the evaluation of patients with IDBS, there are several endoscopic and molecular modalities that may also aid in establishing a diagnosis. Further head-to-head prospective diagnostic studies as well as cost-efficacy studies are needed.

Background & Aims: Disposable, single-use duodenoscopes might reduce outbreaks of infections associated with endoscope reuse. We tested the feasibility, preliminary safety, and performance of a new single-use duodenoscope in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP)., Methods: We conducted a case-series study of the outcomes of ERCP with a single-use duodenoscope from April through May 2019 at 6 academic medical centers. We screened consecutive patients (18 years and older) without alterations in pancreaticobiliary anatomy and enrolled 73 patients into the study. Seven expert endoscopists performed roll-in maneuvers (duodenoscope navigation and visualization of duodenal papilla only) in 13 patients and then ERCPs in the 60 other patients. Outcomes analyzed included completion of ERCP for the intended clinical indication, crossover from a single-use duodenoscope to a reusable duodenoscope, endoscopist performance ratings of the device, and serious adverse events (assessed at 72 hours and 7 days)., Results: Thirteen (100%) roll-in maneuver cases were completed using the single-use duodenoscope. ERCPs were of American Society for Gastrointestinal Endoscopy procedural complexity grade 1 (least complex; 7 patients [11.7%]), grade 2 (26 patients [43.3%]), grade 3 (26 patients [43.3%]), and grade 4 (most complex; 1 patient [1.7%]). Fifty-eight ERCPs (96.7%) were completed using the single-use duodenoscope only and 2 ERCPs (3.3%) were completed using the single-use duodenoscope followed by crossover to a reusable duodenoscope. Median overall satisfaction was 9 out of 10. Three patients developed post-ERCP pancreatitis, 1 patient had post-sphincterotomy bleeding, and 1 patient had worsening of a preexisting infection and required rehospitalization., Conclusions: In a case-series study, we found that expert endoscopists can complete ERCPs of a wide range of complexity using a single-use duodenoscope for nearly all cases. This alternative might decrease ERCP-related risk of infection. Clinicaltrials.gov no: NCT03701958., (Copyright © 2020 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background and study aims  First-generation optical coherence tomography (OCT) has been shown to increase diagnostic sensitivity for malignant biliary and pancreatic-duct strictures. A newer OCT imaging system, NVision Volumetric Laser Endomicroscopy (VLE), allows for in vivo cross-sectional imaging of the ductal wall at the microstructure level during endoscopic retrograde cholangiopancreatography (ERCP). The aim of this study was to identify and evaluate characteristics on OCT that are predictive of benign and malignant strictures. Patients and methods  Consecutive patients from six centers who underwent OCT between September 2016 and September 2017 were included in a dedicated registry. OCT images were analyzed, and nine recurring characteristics were further assessed. Final diagnosis was based on histology and/or surgical pathology. Results  86 patients were included (49 % male, mean age 64.7). OCT was performed in the bile duct in 79 patients and the pancreatic duct in seven. Nine OCT characteristics were identified: dilated hypo-reflective structures (n = 7), onion-skin layering (n = 8), intact layering (n = 17), layering effacement (n = 25), scalloping (n = 20), thickened epithelium (n = 42), hyper-glandular mucosa (n = 13), prominent blood vessels (n = 6), and a hyper-reflective surface (n = 20). Presence of hyper-glandular mucosa, hyper-reflective surface and scalloping significantly increased the odds of malignancy diagnosis by 6 times more ( P  = 0.0203; 95 % CI 1.3 to 26.5), 4.7 times more ( P  = 0.0255; 95 % CI 1.2 to 18.0) and 7.9 times more ( P  = 0.0035; 95 % CI 1.97 to 31.8) respectively. Conclusion  By providing in-vivo cross-sectional imaging of the pancreatic and biliary duct wall, OCT technology may improve sensitivity in diagnosing malignant strictures and provide standardizable criteria predictive of malignancy., Competing Interests: Competing interests Dr. Raijman has served on the speaker/advisory board for Boston Scientific, advisory board for Pentax and Microtech, speakers boards for Conmed and Medtronic and is a co-owner of EndoRx. Dr. Sejpal is a consultant for Boston Scientific, Olympus and Ninepoint Medical and has received grant support from Boston Scientific. Dr. Das is a consultant for Boston Scientific, has received grant support from Interpace Diagnostics and Hygieacare Inc., and serves as a speaker for Olympus America. Dr. Sachdeve is a consultant and speaker for Boston Scientific, Olympus and Microtech and a speaker for Olympus and Aries. Drs. Tarnasky and Kedia are consultants for Boston Scientific. Dr. Gaidhane is a consultant for Interscope Med. Dr. Joshi is a consultant and receives research grants from Olympus America, Maunakea Technologies and Ninepoint Medical. Dr. Kahaleh receives grant support from Boston Scientific, MauneaKea, Apollo Endosurgery, Cook Endoscopy, ASPIRE Bariatrics, NinePoint Medical, Merit Medical, Olympus, and Interscope Med and is a consutlant for Boston Scientific, Concordia Laboratories, Inc., AbbVie and MaunaKea Tech.

Backgrounds: Endoscopic ultrasound (EUS)-guided placement of lumen-apposing metal stents (LAMSs) has gained popularity for the treatment of pancreatic walled-off necrosis (WON). We compared the 20-mm and 15-mm LAMSs for the treatment of symptomatic WON in terms of clinical success and adverse events., Methods: We conducted a retrospective, case-matched study of 306 adults at 22 tertiary centers from 04/2014 to 10/2018. A total of 102 patients with symptomatic WON who underwent drainage with 20-mm LAMS (cases) and 204 patients who underwent drainage with 15-mm LAMS (controls) were matched by age, sex, and drainage approach. Conditional logistic regression analysis was performed to compare clinical success (resolution of WON on follow-up imaging without reintervention) and adverse events (according to American Society for Gastrointestinal Endoscopy criteria)., Results: Clinical success was achieved in 92.2 % of patients with 20-mm LAMS and 91.7 % of patients with 15-mm LAMS (odds ratio 0.92; P  = 0.91). Patients with 20-mm LAMS underwent fewer direct endoscopic necrosectomy (DEN) sessions (mean 1.3 vs. 2.1; P  < 0.001), despite having larger WON collections (transverse axis 118.2 vs. 101.9 mm, P  = 0.003; anteroposterior axis 95.9 vs. 80.1 mm, P  = 0.01). There was no difference in overall adverse events (21.6 % vs. 15.2 %; P  = 0.72) and bleeding events (4.9 % vs. 3.4 %; P  = 0.54) between the 20-mm and 15-mm LAMS groups, respectively., Conclusions: The 20-mm LAMS showed comparable clinical success and safety profile to the 15-mm LAMS, with the need for fewer DEN sessions for WON resolution., Competing Interests: Drs. Arlt, Ellrichmann, Aparicio, Sejpal, Irani, Pawa, Ahmed, Sedarat, Hampe, Sharaiha, Berzin, Stevens, Willingham, Kushnir, Ngamruengphong, Hugget, Baron, Repici, Adler, Nasr, Kowalski, Kumbhari, and Khashab are consultants for Boston Scientific. Dr. Trindade is a consultant for Pentax Medical and CSA Medical. Dr. Benias is a consultant for Fujifilm, Medtronic, and Apollo. Dr. Sejpal is also a consultant for Olympus America. Dr. Ahmed is also a consultant for Cook Medical. Dr. Hampe is also a consultant for Cook Medical, Olympus America, and B. Braun. Dr. Sharaiha is also a consultant for Olympus America and Apollo. Dr. Chahal is a consultant for Medtronic. Dr. Willingham is also a consultant for RedPath, Cook Medical, Xlumena, Oncolys Biopharma, and has received research funding to the university from Cancer Prevention Pharmaceuticals. Dr. Hugget is also a consultant for Cook Medical. Dr. Repici has also received research funding from Boston Scientific. Dr. Kumbhari is also a consultant for Medtronic, Reshape Lifesciences, and Apollo Endosurgery, and has received research support from ERBE and Apollo Endosurgery. Dr. Singh is a consultant for Abbvie and Novo Nordisk, and is a member of an advisory board for Akcea. Dr. Khashab is also a consultant for Olympus America and Medtronic. All other authors have no conflict of interest to disclose., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background and Aims: Multidrug-resistant infectious outbreaks associated with duodenoscope reuse have been documented internationally. A single-use endoscope could eliminate exogenous patient-to-patient infection associated with ERCP., Methods: We conducted a comparative bench simulation study of a new single-use and 3 models of reusable duodenoscopes on a synthetic anatomic bench model. Four ERCP tasks were performed: guidewire locking (single-use and 1 reusable duodenoscope only), plastic stent placement and removal, metal stent placement and removal, and basket sweeping. The study schedule included block randomization by 4 duodenoscopes, 4 tasks, and 2 anatomic model ERCP stations. Ability to complete tasks, task completion times, and subjective ratings of overall performance, navigation/pushability, tip control, and image quality on a scale of 1 (worst) to 10 (best) were compared among duodenoscopes., Results: All 4 ERCP tasks (total 14 subtasks) were completed by 6 expert endoscopists using all 4 duodenoscopes, with similar task completion times (median, 1.5-8.0 minutes per task) and overall performance ratings by task (median, 8.0-10.0). Navigation/pushability ratings were lower for the single-use duodenoscope than for the 3 reusable duodenoscopes (median, 8.0, 10.0, 9.0, and 9.0, respectively; P < .01). Tip control ratings were similar among all the duodenoscopes (median, 9.0-10.0; P = .77). Image quality ratings were lower for 1 reusable duodenoscope compared with the single-use and other 2 reusable duodenoscopes (median, 8.0, 9.0, 9.0, and 9.0, respectively; P < .01)., Conclusions: A new single-use duodenoscope was used to simulate 4 ERCP tasks in an anatomic model, with performance ratings and completion times comparable with 3 models of reusable duodenoscopes., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Introduction: Little is known about the additive yield of wide-area transepithelial sampling with computer-assisted three-dimensional analysis (WATS-3D) after a thorough examination with advanced imaging. The aim was to evaluate the adjunctive yield of WATS-3D after advanced imaging., Methods: This is an observational cohort study from January 2017 to December 2018 for consecutive patients who underwent an examination that consists of high-definition white light endoscopy (HDWLE), narrow-band imaging (NBI), volumetric laser endomicroscopy (VLE), and Seattle protocol (SP) biopsies (collectively termed HDWLE-NBI-VLE-SP examination). Raised lesions were removed by endoscopic resection. Areas suspicious for dysplasia on NBI and VLE were biopsied. This was followed by random biopsies and WATS-3D brush biopsies., Results: One hundred thirty-eight cases were included in this study. Thirty-five cases (25% of the total) were identified as some degree of dysplasia on the HDWLE-NBI-VLE-SP examination. Adjunctive use of WATS-3D yielded an additional 12 new cases of dysplasia (9 with crypt dysplasia and 3 with low-grade dysplasia [LGD]), for added yield of 34.3% (=12/35, 95% confidence interval 14.6%-62.2%). When restricting the analysis to LGD and higher, 21 dysplastic cases (15% of the total cases) were identified by HDWLE-NBI-VLE-SP, while WATS-3D found 4 additional new cases (3 with LGD and 1 with high-grade dysplasia) for an added yield of 19% (=4/21, 95% confidence interval 0.6%-45.7%)., Discussion: The addition of WATS-3D to an already thorough examination with HDWLE-NBI-VLE-SP may increase the yield of dysplasia detection.

Objective: Volumetric laser endomicroscopy (VLE) is an advanced imaging modality used in Barrett's oesophagus (BE) to help identify dysplasia in the oesophagus. VLE criteria exist for oesophageal dysplasia but not for dysplasia in the gastric cardia. The aim of this study was to determine if there are in vivo VLE features that can predict gastric cardia dysplasia in BE., Design: This was a single-centre observational cohort study from August 2016 to August 2018. Patients were included if they had BE, were undergoing a VLE exam as standard of care, and had a suspicious target laser marked at the gastric cardia. The following VLE features were correlated to histology to determine if an association existed between histology subtype and VLE feature: wide crypts, irregular surface, one large isolated gland, multiple glands, and complex glands., Results: A total of 110 in vivo gastric cardia targets in 77 patients with BE were analysed. The following abnormalities were identified: 61 wide crypts, 34 isolated glands, 16 irregular surfaces, 15 multiple glands, and 11 complex glands. Complex glands were the only VLE feature that correlated to any histology subtype. They were present in 71% of targets with high-grade dysplasia (HGD), T1a cancer or T1b cancer and had a sensitivity, specificity, and accuracy of 71%, 99%, and 85%, respectively. Of the 10 patients with complex glands on VLE and HGD/cancer on histology, 4 had a normal-appearing mucosa (40%) on endoscopy., Conclusion: Identification of complex glands on VLE may aid in detection of HGD or early cancer in the gastric cardia in BE. This is particularly important, as dysplasia at the gastric cardia can be difficult to see endoscopically., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background and Aims: Peroral endoscopic myotomy (POEM) has emerged as a promising treatment option for achalasia and other foregut dysmotility disorders. However, much of the current postprocedural care, such as mandatory admission and routine esophagrams, has been adapted from current surgical practices and may not in fact be necessary. Here, we describe our algorithm and outcomes for same-day discharge., Methods: Outcomes of 103 consecutive patients who underwent POEM for achalasia and other foregut dysmotility disorders from January 2015 to December 2018 were analyzed. Patients were discharged on the same day without esophagrams following a predetermined algorithm based on procedural adverse events and postprocedural pain. Patients were closely monitored after discharge for adverse events at 24 and 48 hours and then routinely in the office setting., Results: Of the 103 POEMs, 101 were completed successfully. A total of 62.4% of patients were discharged safely on the same day, 29.7% were admitted for mild pain, and 7.9% were admitted for observation for other reasons. Overall, there were no serious adverse events at any time point. Univariate analysis identified duration of disease greater than 3 years, longer length of procedure (50.9 vs 68.5 min, P < .0001), and longer length of myotomy (7.2 vs 8.5 cm, P < .0068) as significant factors associated with postprocedural pain requiring admission., Conclusions: Although same-day discharge and foregoing routine esophagram have been suggested by many, this routine has not been systematically implemented. This series suggests that an algorithm for same-day discharge based on postprocedure chest pain and procedural complexity is both safe and feasible., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Patient and procedure verification, or the time-out process (TOP), is considered one of the most vital components of patient safety. It has long been a focus of intervention in the surgical community and recently was incorporated into the American Society for Gastrointestinal Endoscopy guidelines for safety in the GI endoscopy unit. The TOP has had limited attention in the endoscopy literature but remains an area for improvement in clinical endoscopy practice. The aim of this study was to identify barriers and improve TOP compliance rates in our endoscopy unit using remote video auditing (RVA)., Methods: This was a single-center, prospective, pilot initiative in an endoscopy unit at a tertiary care academic medical center. Video cameras with offsite monitoring were installed in each procedure room in our endoscopy suite in November 2016. Baseline TOP compliance rates were audited with RVA over a 2-month period. A multidisciplinary quality improvement team reviewed the data, identified barriers to the TOP, and implemented actionable items in January 2017. TOP compliance rates were again monitored via RVA, and data were collected through October 2018. Pre- and postintervention TOP compliance rates were compared., Results: Over the baseline period, 692 procedures were audited and TOP compliance documented. Baseline TOP compliance rate was 69.6%. Identifiable barriers to TOP compliance included a lack of designated team member to lead TOP, inconsistent documentation of TOP, irrelevant safety checklist items not applicable to endoscopic procedures, and lack of patient safety culture. Actionable items implemented in response to these barriers included designation of a TOP leader, visual indication of initiation of TOP, creation of a concise endoscopy-specific safety checklist, and formal notification/education of the entire endoscopy team. Postintervention TOP compliance rates were then audited from January 2017 to October 2018 and included 12,008 procedures. The mean TOP compliance rate significantly improved from baseline (95.3% vs 69.6%; 95% confidence interval, 22.4-29.3; P < .0001). Additionally, the improvement was maintained throughout the entire postintervention observation period., Conclusions: TOP compliance rates significantly improved in our endoscopy unit through the use of RVA and implementation of 4 actionable items. Future studies should evaluate the reproducibility of this method in other endoscopy units., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and study aims  There are numerous studies published on the diagnostic yield of the new fine-needle biopsy (FNB) needles in pancreas masses. However, there are limited studies in suspected gastrointestinal stromal tumors (GIST lesions). The aim of this study was to evaluate the diagnostic yield of a new fork-tip FNB needle. Patients and methods  This was a multicenter retrospective study of consecutive patients from prospectively maintained databases comparing endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) versus endoscopic ultrasound-guided FNB (EUS-FNB) using the fork-tip needle. Outcomes measured were cytopathology yield (ability to obtain tissue for analysis of cytology), ability to analyze the tissue for immunohistochemistry (IHC yield), and diagnostic yield (ability to provide a definitive diagnosis). Results  A total of 147 patients were included in the study of which 101 underwent EUS-FNB and 46 patients underwent EUS-FNA. Median lesion size in each group was similar (21 mm vs 25 mm, P  = 0.25). Cytopathology yield, IHC yield, and diagnostic yield were 92 % vs 46 % ( P  = 0.001), 89 % vs 41 % ( P  = 0.001), and 89 % vs 37 % ( P  = 0.001) between the FNB and FNA groups, respectively. Median number of passes was the same between the two groups at 3.5. Conclusion  EUS-FNB is superior to EUS-FNA for diagnostic yield of suspected GIST lesions. This should be confirmed with a prospective study.

Background and study aims  After stone removal in endoscopic retrograde cholangiopancreatography (ERCP), an occlusion cholangiogram (OC) is performed to confirm bile duct clearance. OC can miss residual stones that can lead to recurrent biliary symptoms. The aim of this study was to assess if digital peroral cholangioscopy (POC) increased the diagnostic yield of residual biliary stones that are missed with OC. Patients and methods  Patients having ERCP performed for choledocholithiasis were enrolled into the study only if they had one of the following criteria: dilated bile duct ≥ 12 mm and/or if lithotripsy was being performed. An OC was performed to confirm duct clearance after removal of stones followed by POC, based on inclusion criteria. The incremental yield of biliary stones missed by OC but confirmed by POC was then measured. A total of 96 POC procedures were performed on 93 patients in two tertiary care centers. Results  Residual biliary stones were found in 34 % of cases. The average bile duct size in cases with residual stones was 15.1 mm ± 0.7 mm. One- to three-mm stones were found in 41 % of cases, 4- to 7-mm stones in 45 % of cases, and ≥ 8-mm stones in 14 % of cases. Lithotripsy was performed in 13 % of cases and was significantly associated with residual stones (30 % vs. 3 %, P  < 0.001). Conclusions  Occlusion cholangiogram can miss residual stones in patients with dilated bile ducts and those receiving lithotripsy. Digital POC can increase the yield of residual stone detection in these patients and should be considered to confirm clearance of stones. (ClinicalTrials.gov-NCT03482375).

Background and study aims  The use of lumen apposing metal stents (LAMS) during EUS-guided transmural drainage (EUS-TD) of pancreatic walled-off necrosis (WON) has gained popularity. Data supporting their use in WON over plastic stents (PS), however, remain scarce. The aim of this study was to compare the clinical efficacy of LAMS (Axios, Boston Scientific) with PS in WON. Patients and methods  This was a multicenter, retrospective study involving 14 centers. Consecutive patients who underwent EUS-TD of WON (2012 - 2016) were included. The primary end point was clinical success defined as WON size ≤ 3 cm within a 6-month period without need for percutaneous drainage (PCD) or surgery. Results  A total of 189 patients (mean age 55.2 ± 15.6 years, 34.9 % female) were included (102 LAMS and 87 PS). Technical success rates were similar: 100 % in LAMS and 98.9 % in PS ( P  = 0.28). Clinical success was attained in 80.4 % of LAMS and 57.5 % of PS ( P  = 0.001). Rate of PCD was similar (13.7 % LAMS vs. 16.3 % PS, P  = 0.62), while PS was associated with a greater need for surgery (16.1 % PS vs. 5.6 % LAMS, P  = 0.02). Adverse events (AEs) were observed in 9.8 % of LAMS and 10.3 % of PS ( P  = 0.90) and were rated as severe in 2.0 % and 6.9 %, respectively ( P  = 0.93). After excluding patients with < 6 months follow-up, the rate of WON recurrence following initial clinical success was greater with PS (22.9 % PS vs. 5.6 % LAMS, P  = 0.04). Conclusions  When compared to PS, LAMS in WON is associated with higher clinical success, shorter procedure time, lower need for surgery, and lower rate of recurrence.

Background: Endoscopic mucosal resection of large non-pedunculated colon polyps is challenging., Objective: To determine if the time of day or daily endoscopic workload play a role in outcomes of endoscopic mucosal resection for large non-pedunculated colon polyps greater than 20 mm., Methods: This is a retrospective study of patients who underwent endoscopic mucosal resection of large non-pedunculated colon polyps. The time of day and endoscopic workload were compared across the following outcomes: the rate of complete resection of the polyp, the rate of referral for surgery, and the rate of residual neoplasia on follow-up., Results: One hundred and three endoscopic mucosal resection procedures were performed. There were no differences in the rates of complete resection (80.8% vs. 70.0%; P  = 0.25), the need for surgery (27.4% vs. 33.3%; P  = 0.55), and rate of residual neoplasia (24.5% vs. 50.0%; P  = 0.07) when comparing the time of day. Colon polyps greater than 40 mm were less likely to be completely resected versus polyps sized 20-39 mm (56.8% vs. 91.9%; P  < 0.001). In cases with no residual neoplasia on follow-up, the mean duration for the index procedure was 45.6 minutes versus 60.7 minutes when there was residual neoplasia ( P  < 0.01)., Conclusion: The time of day and endoscopic workload does not affect outcomes for endoscopic mucosal resection of large non-pedunculated colon polyps, but the size of large non-pedunculated colon polyps and resection times do.

Introduction: In patients with pancreaticobiliary lesions anticipating surgical resection, digital pancreaticocholangioscopy can be used to identify the extent of disease. This presurgical"mapping" could change the surgical plan and optimize patient care., Materials and Methods: Patients with pancreaticobiliary lesions anticipating surgery who underwent endoscopic retrograde cholangiopancreatography with digital pancreaticocholangioscopy from 9 international centers were included. Primary outcome was whether pancreaticocholangioscopy altered the surgical plan. Secondary outcome was correlation between surgical and endoscopic histology and adverse events., Results: A total of 118 patients were included (64% male, mean age 69 y): cholangioscopy in 105 patients (89%), pancreatoscopy in 13 patients (11%). Pancreaticocholangioscopy changed the surgical plan in 39 (34%) of patients: 8 of 13 in the pancreatic duct, 32 of 105 in the bile duct. In the bile duct, 6 patients (5%) had less extensive surgery, 26 patients (25%) avoided surgery. In the pancreatic duct, 4 patients (31%) had more extensive surgery and 4 patients (31%) had less extensive surgery. Four patients with downstaged surgery had positive margins on surgical resection; 1 required additional surgical intervention. Overall correlation between endoscopy and surgical histology was 88%. Adverse events included post endoscopic retrograde cholangiopancreatography pancreatitis in 3 patients (2.5%)., Conclusion: Digital pancreaticocholangioscopy can be effectively used as a mapping tool to delineate the degree of involvement of biliary lesions before surgical resection, in some cases altering the surgical plan. Prospective studies are needed, especially when downstaging surgery.

Background: The aim of this study was to investigate the outcomes of digital pancreatoscopy in main duct intraductal papillary mucinous neoplasm (MD-IPMN)., Methods: This was a multicenter retrospective study. Outcomes analyzed were safety, incremental pathology yield compared with previous cross-sectional/endoscopic ultrasound (EUS) imaging, and whether the surgical procedure was dictated by the pancreatoscopy., Results: A total of 31 patients were enrolled from six tertiary care centers. Overall, 42 % of cases had findings on pancreatoscopy that were not seen on cross-sectional imaging or EUS. Digital pancreatoscopy dictated the type of surgery performed in 13 patients (42 %) who underwent surgery. However, in patients with a diffusely dilated pancreatic duct (> 10 mm), the pancreatoscopy dictated the type of surgery in 77 % of cases vs. 17 % of cases in the focally dilated pancreatic duct group (10/13 vs. 3/18; P  = 0.001)., Conclusion: Digital pancreatoscopy should be considered in the diagnostic algorithm of MD-IPMN in patients with a diffusely dilated pancreatic duct and without any focal lesions seen on cross-sectional imaging or EUS., Competing Interests: Douglas G. Adler: Boston Scientific, (© Georg Thieme Verlag KG Stuttgart · New York.)

Background and Aims: Endoscopic ultrasound-guided transmural drainage using lumen apposing metal stents (LAMSs) is becoming a popular and promising therapeutic approach for drainage of intra-abdominal fluid collections. There has been an increasing number of studies evaluating LAMS for drainage of pancreatic pseudocysts (PP), walled-off pancreatic necrosis (WOPN), and gallbladder (GB) drainage. The aim of this meta-analysis is to analyze the literature to date regarding the clinical success, technical success, and adverse events of LAMS in treatment of pancreatic fluid collections and GB drainage., Methods: A comprehensive search of multiple literature databases through November 2016 was performed. Human studies with at least 10 subjects that examined the clinical success, technical success, and adverse events of LAMS in treating PP, WOPN, and GB drainage were included., Results: A total of 993 patients (608-WOPN; 204-PP; 181-GB drainage) underwent drainage from 20 trials. For drainage of WOPN, the pooled technical success was 98.9% [95% confidence interval (CI): 98.2% to 99.7%] and clinical success was 90% (95% CI: 87% to 93%) (τ=0.001). For drainage of PP, the pooled technical success was 97% (95% CI: 95% to 99%) and clinical success was 98% (95% CI: 96% to 100%), (τ=0.001). For GB drainage, the pooled technical success was 95% (95% CI: 91% to 99%) and clinical success was 93% (95% CI: 90% to 97%), (τ=0.001). Total adverse events occurred in 11% of patients with higher complication rates observed in GB drainage. There was no evidence of publication bias in this meta-analysis., Conclusions: Endoscopic ultrasound-guided transmural drainage using LAMS is becoming a widely accepted therapeutic approach for the treatment of PP, WOPN, and GB drainage with high clinical and technical success rates and acceptable adverse events. Further prospective randomized trials reporting long-term clinical efficacy and cost-effectiveness are needed to validate LAMS as a therapeutic modality for pancreatic and GB collections.

Pancreatic cancer is the most lethal common solid malignancy. Systemic therapies are often ineffective, and predictive biomarkers to guide treatment are urgently needed. We generated a pancreatic cancer patient-derived organoid (PDO) library that recapitulates the mutational spectrum and transcriptional subtypes of primary pancreatic cancer. New driver oncogenes were nominated and transcriptomic analyses revealed unique clusters. PDOs exhibited heterogeneous responses to standard-of-care chemotherapeutics and investigational agents. In a case study manner, we found that PDO therapeutic profiles paralleled patient outcomes and that PDOs enabled longitudinal assessment of chemosensitivity and evaluation of synchronous metastases. We derived organoid-based gene expression signatures of chemosensitivity that predicted improved responses for many patients to chemotherapy in both the adjuvant and advanced disease settings. Finally, we nominated alternative treatment strategies for chemorefractory PDOs using targeted agent therapeutic profiling. We propose that combined molecular and therapeutic profiling of PDOs may predict clinical response and enable prospective therapeutic selection. Significance: New approaches to prioritize treatment strategies are urgently needed to improve survival and quality of life for patients with pancreatic cancer. Combined genomic, transcriptomic, and therapeutic profiling of PDOs can identify molecular and functional subtypes of pancreatic cancer, predict therapeutic responses, and facilitate precision medicine for patients with pancreatic cancer. Cancer Discov; 8(9); 1112-29. ©2018 AACR. See related commentary by Collisson, p. 1062 This article is highlighted in the In This Issue feature, p. 1047 ., (©2018 American Association for Cancer Research.)

Background and Aims: Volumetric laser endomicroscopy (VLE) is a new wide-field advanced imaging technology for Barrett's esophagus (BE). No data exist on incremental yield of dysplasia detection. Our aim is to report the incremental yield of dysplasia detection in BE using VLE., Methods: This is a retrospective study from a prospectively maintained database from 2011 to 2017 comparing the dysplasia yield of 4 different surveillance strategies in an academic BE tertiary care referral center. The groups were (1) random biopsies (RB), (2) Seattle protocol random biopsies (SP), (3) VLE without laser marking (VLE), and (4) VLE with laser marking (VLEL)., Results: A total of 448 consecutive patients (79 RB, 95 SP, 168 VLE, and 106 VLEL) met the inclusion criteria. After adjusting for visible lesions, the total dysplasia yield was 5.7%, 19.6%, 24.8%, and 33.7%, respectively. When compared with just the SP group, the VLEL group had statistically higher rates of overall dysplasia yield (19.6% vs 33.7%, P = .03; odds ratio, 2.1, P = .03). Both the VLEL and VLE groups had statistically significant differences in neoplasia (high-grade dysplasia and intramucosal cancer) detection compared with the SP group (14% vs 1%, P = .001 and 11% vs 1%, P = .003)., Conclusion: A surveillance strategy involving VLEL led to a statistically significant higher yield of dysplasia and neoplasia detection compared with a standard random biopsy protocol. These results support the use of VLEL for surveillance in BE in academic centers., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: Accurate staging of superficial esophageal squamous cell cancer (ESCC) for endoscopic therapy is challenging. Optical coherence tomography (OCT) has been shown to be superior to high-resolution endoscopic ultrasound (EUS). Volumetric Laser Endomicroscopy (VLE), a second-generation OCT, has recently become commercially available., Objective: To assess if VLE can determine which patients with superficial ESSC can undergo endoscopic therapy., Methods: This is a multi-center retrospective study. Patients were included if (a) they had visible ESCC, (b) they underwent VLE and EUS for staging, and c) if superficial disease was suspected then endoscopic resection had to be performed to have accurate histology to compare the VLE scan to. VLE scans were then compared to the gold standard: histology for superficial disease and EUS for disease T1b and greater., Results: Seventeen patients were included with the following disease: squamous intraepithelial neoplasia (4 patients), T1a disease (6 patients), T1b (2 patients), T2 disease (2 patients) and T3 disease (3 patients). VLE was able to distinguish superficial disease, defined as disease limited up to the lamina propria, from non-superficial disease in all cases., Conclusions: VLE may be able to determine which ESCC patients are candidates for endoscopic therapy. Prospective studies are needed to confirm this.

Background and Aims: There are limited data on the use of volumetric laser endomicroscopy (VLE) for imaging colon polyps. Our aim was to identify VLE features of colon polyps., Methods: A total of 45 patients were included; 43 underwent endoscopic mucosal resection of colorectal polyps 2 cm or greater. These polyps were then scanned with VLE immediately after resection. Two patients who underwent partial colonic resection served as controls., Results: Forty-three polyps were included with review of matching histology: 3 intramucosal cancer (IMCA), 5 tubular adenoma (TAs)/tubulovillous adenoma (TVA) with high-grade dysplasia (HGD), 9 TVA with only low-grade dysplasia (LGD), 5 serrated adenoma, and 21 TA with LGD. All TAs and TVAs were hyper-reflective compared with normal tissue. Effacement occurred in 82.4% (14/17) of the colonic polyps with advanced pathology (TVA with HGD/IMCA) compared with 11.6% (3/26) with non-advanced pathology (TA with LGD and serrated adenoma) (P < .0001). Forty-seven percent (8/17) of polyps with advanced pathology had greater than 5 glands on VLE compared with none in the non-advanced pathology group (P = .0001). An irregular surface mainly occurred in polyps with high-grade pathology (HGD/IMCA) versus TAs. Eighty-eight percent of polyps with HGD/IMC had an irregular surface (7/8) versus 6% (2/35) of TAs (P < .0001)., Conclusions: In this ex vivo clinicopathologic study, we show that there are distinct VLE features of colon polyps that may help identify polyps or features of a higher-grade lesion. This may have implications for possible in vivo application to aid in dysplasia or polyp detection., (Copyright © 2018 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background & Aims: It is not clear whether digital single-operator cholangioscopy (D-SOC) with electrohydraulic and laser lithotripsy is effective in removal of difficult biliary stones. We investigated the safety and efficacy of D-SOC with electrohydraulic and laser lithotripsy in an international, multicenter study of patients with difficult biliary stones., Methods: We performed a retrospective analysis of 407 patients (60.4% female; mean age, 64.2 years) who underwent D-SOC for difficult biliary stones at 22 tertiary centers in the United States, United Kingdom, or Korea from February 2015 through December 2016; 306 patients underwent electrohydraulic lithotripsy and 101 (24.8%) underwent laser lithotripsy. Univariate and multivariable analyses were performed to identify factors associated with technical failure and the need for more than 1 D-SOC electrohydraulic or laser lithotripsy session to clear the bile duct., Results: The mean procedure time was longer in the electrohydraulic lithotripsy group (73.9 minutes) than in the laser lithotripsy group (49.9 minutes; P < .001). Ducts were completely cleared (technical success) in 97.3% of patients (96.7% of patients with electrohydraulic lithotripsy vs 99% patients with laser lithotripsy; P = .31). Ducts were cleared in a single session in 77.4% of patients (74.5% by electrohydraulic lithotripsy and 86.1% by laser lithotripsy; P = .20). Electrohydraulic or laser lithotripsy failed in 11 patients (2.7%); 8 patients were treated by surgery. Adverse events occurred in 3.7% patients and the stone was incompletely removed from 6.6% of patients. On multivariable analysis, difficult anatomy or cannulation (duodenal diverticula or altered anatomy) correlated with technical failure (odds ratio, 5.18; 95% confidence interval, 1.26-21.2; P = .02). Procedure time increased odds of more than 1 session of D-SOC electrohydraulic or laser lithotripsy (odds ratio, 1.02; 95% confidence interval, 1.01-1.03; P < .001)., Conclusions: In a multicenter, international, retrospective analysis, we found D-SOC with electrohydraulic or laser lithotripsy to be effective and safe in more than 95% of patients with difficult biliary stones. Fewer than 5% of patients require additional treatment with surgery and/or extracorporeal shockwave lithotripsy to clear the duct., (Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background and Study Aims: Little is known about the learning curve for image interpretation in volumetric laser endomicroscopy (VLE) in Barrett's esophagus (BE). The goal of this study was to calculate the learning curve, competence of image interpretation, sensitivity, specificity, and accuracy of VLE among novice users., Methods: 31 novice users viewed 96 VLE images electronically at three academic institutions after a brief training session. There were 24 images of each histologic type: normal gastric cardia, normal esophageal squamous epithelium, non-neoplastic BE, and neoplastic BE. The users were asked to identify the correct tissue type and level of confidence. The cumulative summation (CUSUM) technique was used to construct a learning curve., Results: 22 (71 %) of the physicians achieved VLE interpretation competency during their 96-slide review. Half of the physicians achieved competency at 65 images (95 % confidence interval [CI] 45 - 85). There was a statistically significant association between confidence in diagnosis and selecting the correct histologic tissue type ( P  < 0.001). The median accuracy for esophageal squamous epithelium, normal gastric cardia, non-neoplastic BE, and neoplastic BE was 96 % (95 %CI 95 % - 96 %), 95 % (95 %CI 94 % - 96 %), 90 % (95 %CI 88 % - 91 %), 96 % (95 %CI 95 % - 96 %). The overall accuracy was 95 % (95 %CI 93 % - 95 %)., Conclusion: The majority of novice users achieved competence in image interpretation of VLE for BE, using a pre-selected image set, with a favorable learning curve after a brief training session. An electronic review of VLE images, prior to real-time use of VLE, is encouraged., Competing Interests: K.J.C., C.J.L., C.L.L., M.S.S., and M.B.W. have received research funding from Ninepoint Medical. D.K.P. and M.S.S. are consultants for Ninepoint Medical. G.J.T. (Massachusetts General Hospital) has a licensing arrangement with NinePoint Medical, and has the right to receive royalties from this licensing arrangement.G.J.T. also receives grants from the Bill and Melinda Gates Foundation and iLumen Medical., (© Georg Thieme Verlag KG Stuttgart · New York.)

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Objectives: Separate-session endoscopic retrograde cholangiography (ERCP) and laparoscopic cholecystectomy (LC) is the usual method for management of inpatient choledocholithiasis. Our goal was to compare single operative-session LC and ERCP to a multi-session approach for both the same hospitalization and within 30 days after; there is limited data comparing the three groups., Methods: A retrospective review on inpatients with choledocholithiasis that underwent ERCP and LC was performed. Single operative-session ERCP + LC (SOS group) and separate hospitalization ERCP + LC (DH group) were compared against the control cohort: separate-session ERCP + LC performed during the same hospitalization (SH group)., Results: Among the 214 cases, 37 (17%) had LC + ERCP performed under a single operative session (SOS), 130 (60.7%) cases had LC + ERCP performed in separate operative sessions during the same hospitalization (SH), and 47 (22%) cases had LC + ERCP performed in different hospitalizations, within 30 days (DH). There was no statistically significant difference in efficacy or adverse events. The SOS group had a statistically significant mean shorter length of hospital stay as compared to the SH and DH groups (5.46 vs 7.15 vs 9.38; p = 0.05 and 0.02). There was a statistically significant reduction in the total cost of care in the SOS group versus the SH group ($59,221 vs $75, 808; p = 0.007)., Conclusion: The SOS approach is safe, efficacious, and cost-efficient when compared to separate operative sessions. This approach can be considered in situations where it is preferable for the patient to undergo a single session of anesthesia, without compromising technical success and safety.

Competing Interests: Competing interests: A. J. T. has received professional fees from C2 Therapeutics.

Background and Aims: Targeting neoplasia in Barrett's esophagus (BE) is challenging. Volumetric laser endomicroscopy (VLE) is a new imaging technique that allows for real time cross-sectional microstructure imaging that can detect BE neoplasia. The interobserver agreement among users in practice is unknown., Methods: Eight high-volume users of VLE from different academic centers in the United States evaluated 120 stored VLE images blinded to the endoscopic and clinical findings. There were 30 images for each tissue type: gastric cardia, esophageal squamous mucosa, nonneoplastic BE, and neoplastic BE. Each image with BE had corresponding histology confirming the tissue diagnosis. Each normal esophagus and gastric cardia had matching endoscopic images confirming normal mucosa. These were considered the criterion standard. Respondents were asked to classify the images into 1 of each category. Agreement among the users was measured., Results: The overall agreement among users was almost perfect (kappa = 0.81; 95% confidence interval [CI], 0.79-0.83). For esophageal squamous and gastric cardia, the agreement was almost perfect (kappa 0.95 and 0.86, respectively [95% CI, 0.92-0.98 and 0.83-0.89]). For nonneoplastic BE and neoplastic BE, the agreement was strong (kappa 0.66 [95% CI, 0.63-0.69] and 0.79 [95% CI, 0.75-0.82], respectively). When compared with the criterion standard, the median accuracy for identifying normal squamous mucosa, normal gastric mucosa, nonneoplastic BE, neoplastic BE, and all tissue types was 99% (95% CI, 98%-100%), 97% (95% CI, 95%-99%), 93% (95% CI, 88%-98%), 95% (95% CI, 91%-99%), and 96% (95% CI, 94%-99%), respectively., Conclusions: VLE has a high level of agreement and accuracy among high-volume users., (Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)