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Background and Aims: Difficult biliary cannulation (DBC) is a known risk factor for developing post-ERCP pancreatitis (PEP). To better understand how DBC increases PEP risk, we examined the interplay between technical aspects of DBC and known PEP risk factors., Methods: This was a secondary analysis of a multicenter, randomized controlled trial comparing rectal indomethacin alone with the combination of rectal indomethacin and prophylactic pancreatic duct (PD) stent placement for PEP prophylaxis in high-risk patients. Participants were categorized into 3 groups: 1) DBC with high pre-procedure risk for PEP, 2) DBC without high pre-procedure risk, and 3) non-DBC at high pre-procedure risk., Results: In all, 1601 (84.1%) participants experienced DBC, which required a mean of 12 (SD 10) cannulation attempts and mean duration of 14.7 minutes (SD 14.9). PEP rate was highest (20.7%) in DBC with high pre-procedure risk, followed by non-DBC with high pre-procedure risk (13.5%) and then DBC without high pre-procedure risk (8.8%). Increasing number of PD-wire passages (aOR:1.97, 95% CI:1.25-3.1) was associated with PEP in DBC, but PD injection, pancreatic sphincterotomy and number of cannulation attempts were not associated with PEP. Combining indomethacin with PD stenting lowered PEP risk (aOR:0.61, 95% CI:0.44-0.84) in DBCs. This protective effect was evident in up to at least 4 PD wire passages., Conclusions: DBC confers higher PEP risk in additive fashion to pre-procedural risk factors. PD wire passages appear to add the greatest PEP risk in DBCs, but combining indomethacin with PD stenting reduces this risk, even with increasing PD wire passages., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

The use of endoscopic retrograde cholangiography (ERCP) for diagnostic and therapeutic interventions on the pancreaticobiliary system has steadily increased, but the standard approach through the oropharynx is prohibited after Roux-en-Y (RYGB) gastric bypass surgery. Laparoscopic access to the gastric remnant allows for the completion of ERCP using the standard side-viewing duodenoscope to facilitate the completion of standard and advanced endoscopic maneuvers. Here, we describe our experience with the technical aspects of safe and effective performance of laparoscopic-assisted ERCP., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Introduction: Prophylactic pancreatic stent placement (PSP) is effective for preventing pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk cases, but the optimal technical approach to this intervention remains uncertain., Methods: In this secondary analysis of 787 clinical trial patients who underwent successful stent placement, we studied the impact of (i) whether pancreatic wire access was achieved for the sole purpose of PSP or naturally during the conduct of the case, (ii) the amount of effort expended on PSP, (iii) stent length, (iv) stent diameter, and (v) guidewire caliber. We used logistic regression models to examine the adjusted association between each technical factor and post-ERCP pancreatitis (PEP)., Results: Ninety-one of the 787 patients experienced PEP. There was no clear association between PEP and whether pancreatic wire access was achieved for the sole purpose of PSP (vs occurring naturally; odds ratio [OR] 0.82, 95% confidence interval [CI] 0.37-1.84), whether substantial effort expended on stent placement (vs nonsubstantial effort; OR 1.58, 95% CI 0.73-3.45), stent length (>5 vs ≤5 cm; OR 1.01, 95% CI 0.63-1.61), stent diameter (≥5 vs <5 Fr; OR 1.13, 95% CI 0.65-1.96), or guidewire caliber (0.035 vs 0.025 in; 0.83, 95% CI 0.49-1.41)., Discussion: The 5 modifiable technical factors studied in this secondary analysis of large-scale randomized trial data did not appear to have a strong impact on the benefit of prophylactic PSP in preventing PEP after high-risk ERCP. Within the limitations of post hoc subgroup analysis, these findings may have important implications in procedural decision making and suggest that the benefit of PSP is robust to variations in technical approach., (Copyright © 2024 by The American College of Gastroenterology.)

Background: The combination of rectally administered indomethacin and placement of a prophylactic pancreatic stent is recommended to prevent pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients. Preliminary evidence suggests that the use of indomethacin might eliminate or substantially reduce the need for stent placement, a technically complex, costly, and potentially harmful intervention., Methods: In this randomised, non-inferiority trial conducted at 20 referral centres in the USA and Canada, patients (aged ≥18 years) at high risk for post-ERCP pancreatitis were randomly assigned (1:1) to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent. Patients, treating clinicians, and outcomes assessors were masked to study group assignment. The primary outcome was post-ERCP pancreatitis. To declare non-inferiority, the upper bound of the two-sided 95% CI for the difference in post-ERCP pancreatitis (indomethacin alone minus indomethacin plus stent) would have to be less than 5% (non-inferiority margin) in both the intention-to-treat and per-protocol populations. This trial is registered with ClinicalTrials.gov (NCT02476279), and is complete., Findings: Between Sept 17, 2015, and Jan 25, 2023, a total of 1950 patients were randomly assigned. Post-ERCP pancreatitis occurred in 145 (14·9%) of 975 patients in the indomethacin alone group and in 110 (11·3%) of 975 in the indomethacin plus stent group (risk difference 3·6%; 95% CI 0·6-6·6; p=0·18 for non-inferiority). A post-hoc intention-to-treat analysis of the risk difference between groups showed that indomethacin alone was inferior to the combination of indomethacin plus prophylactic stent (p=0·011). The relative benefit of stent placement was generally consistent across study subgroups but appeared more prominent among patients at highest risk for pancreatitis. Safety outcomes (serious adverse events, intensive care unit admission, and hospital length of stay) did not differ between groups., Interpretation: For preventing post-ERCP pancreatitis in high-risk patients, a strategy of indomethacin alone was not as effective as a strategy of indomethacin plus prophylactic pancreatic stent placement. These results support prophylactic pancreatic stent placement in addition to rectal indomethacin administration in high-risk patients, in accordance with clinical practice guidelines., Funding: US National Institutes of Health., Competing Interests: Declaration of interests The following authors have received honoraria, consulting fees, or research support from companies that manufacture prophylactic pancreatic stents or indomethacin within the last 2 years: SAE (consulting fees from Olympus, honoraria from Boston Scientific), NF (consulting fees and payment or honoraria for lectures or receipt of equipment or materials from Boston Scientific and Pentax), FFW (consulting fees from Cook/Boston Scientific), SV (consulting fees from Boston Scientific/Olympus), JYB (consulting fees from Boston Scientific/Olympus), MK (consulting fees from Boston Scientific), RK (consulting fees from Boston Scientific), Y-IC (consulting fees, honoraria, research grants, and travel payments from Boston Scientific), AB (financial interest in Olympus), ARo (payment or honoraria for lectures or presentations and travel from Boston Scientific), and study group members SGK (honoraria and grant support from Taewoong Medical) and SG (consulting fees and honoraria from Boston Scientific). All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: Gastrojejunal strictures (GJS) are rare but significant adverse events following Roux-en-Y Gastric Bypass, with limited options for effective non-operative interventions. Lumen-apposing metal stents (LAMS) represent a new therapy for treatment of intestinal strictures, but the effectiveness in treating GJS is unknown. This study aims to evaluate the safety and effectiveness of LAMS in GJS., Methods: This is a prospective, observational study of patients with prior Roux-en-Y Gastric bypass who underwent LAMS placement for GJS. The primary outcome of interest is resolution of GJS following LAMS removal defined by toleration of bariatric diet after LAMS removal. Secondary outcomes include need for additional procedures, LAMS-related adverse events, and need for revisional surgery., Results: Twenty patients were enrolled. The cohort was 85% female with median age of 43. 65% had marginal ulcers associated with the GJS. Presenting symptoms included nausea and vomiting (50% of patients), dysphagia (50%), epigastric pain (20%), and failure to thrive (10%). Diameter of LAMS placed were 15 mm in 15 patients, 20 mm in 3 patients, and 10 mm in 2 patients. LAMS were placed for a median of 58 days (IQR 56-70). Twelve patients (60%) achieved resolution of GJS after LAMS removal. Of the eight patients without GJS resolution or with recurrence, seven (35%) required repeat placement of LAMS. One patient was lost to follow up. One perforation and two migrations occurred. Four patients required revisional surgery after LAMS removal., Conclusion: LAMS placement is well-tolerated and effective with most patients achieving short-term symptom resolution and with few reported complications. While stricture resolution occurred in over half the patients, nearly 1/4th of patients required revisional surgery. More data is needed to predict who would benefit from LAMS versus surgical intervention., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

The incidence of esophageal adenocarcinoma (EA) has drastically increased in the United States since 1970s for unclear reasons. We hypothesized that the widespread usage of antibiotics has increased the procarcinogenic potential of the orodigestive microbiota along the sequence of gastroesophageal reflux (GR), Barrett's esophagus (BE) and EA phenotypes. This case control study included normal controls (NC) and three disease phenotypes GR, BE and EA. Microbiota in the mouth, esophagus, and stomach, and rectum were analyzed using 16S rRNA gene sequencing. Overall, we discovered 44 significant pairwise differences in abundance of microbial taxa between the four phenotypes, with 12 differences in the mouth, 21 in the esophagus, two in the stomach, and nine in the rectum. Along the GR→BE→EA sequence, oral and esophageal microbiota were more diversified, the dominant genus Streptococcus was progressively depleted while six other genera Atopobium, Actinomyces, Veillonella, Ralstonia, Burkholderia and Lautropia progressively enriched. In NC, Streptococcus appeared to control populations of other genera in the foregut via numerous negative and positive connections, while in disease states, the rich network was markedly simplified. Inferred gene functional content showed a progressive enrichment through the stages of EA development in genes encoding antibiotic resistance, ligands of Toll-like and NOD-like receptors, nitrate-nitrite-nitric oxide pathway and acetaldehyde metabolism. The orodigestive microbiota is in a progressive dysbiotic state along the GR-BE-EA sequence. The increasing dysbiosis and antibiotic and procarcinogenic genes in the disease states warrants further study to define their roles in EA pathogenesis., (© 2022 UICC.)

Background and Aims: Biliary drainage using endoscopic ultrasound (EUS-BD) has been developed as a novel technique to obtain biliary access and drainage when ERCP fails. Numerous studies have demonstrated its safety and efficacy specifically pertaining to those with malignant distal biliary obstruction or altered foregut anatomy. The aim of this study is to evaluate the safety and efficacy of EUS-BD in benign indications in patients with normal foregut anatomy., Methods: We performed a retrospective comparative study from 5 academic medical centers (2008-2018) involving patients with benign biliary obstruction and native foregut anatomy who had an initial failed ERCP with subsequent attempt at biliary decompression via EUS-BD or by repeating ERCP., Results: 36 patients (mean age 61.6 ± 2.2, 38.9% female) who underwent attempted EUS-BD following initial failed ERCP were compared to 50 patients (mean age 62.7 ± 2.3, 73.5% female) who underwent repeat ERCP following an initial failed cannulation. EUS-BD was technically successful in 28 (77.8%) patients with rendezvous being the most common approach (86.1%). A higher level of pre-procedural bilirubin was found to be associated with technical success of EUS-BD (3.65 ± 0.63 versus 1.1 ± 0.4, p value 0.04). Success of repeat ERCP following failed cannulation was 86%. Adverse events were significantly more frequent in the EUS-BD cohort when compared to the repeat ERCP (10 (27.8%) versus 4 (8.0%), p = 0.02, OR 4.32., Conclusions: EUS-BD remains a viable therapeutic option in the setting of benign biliary disease, with success rates of 77.8%. Adverse events were significantly more common with EUS-BD vs. repeat ERCP, emphasizing the need to perform in expert centers with appropriate multidisciplinary support and to strongly consider the urgency of biliary decompression before considering same session EUS-BD after failed initial biliary access., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background and Aims: Patients with biliary obstruction caused by adenocarcinoma of the pancreas head may require bile duct decompression to treat symptomatic cholestasis and/or permit systemic chemotherapy. ERCP with biliary stent placement is the preferred intervention in such cases. The primary aim of this study was to determine what proportion of patients with surgically unresectable pancreatic adenocarcinoma undergo ERCP and whether this proportion has changed over time., Methods: We used Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked data to identify a cohort of individuals diagnosed with adenocarcinoma of the pancreas head between December 31, 2000 and December 31, 2015 and who did not receive pancreas surgery. ERCP use was measured in the 30 days before and after cancer diagnosis. Additional covariates of interest were extracted for multiple variable analysis., Results: A total of 14,810 patients met study inclusion and exclusion criteria. Of them, 53% (7034/14,810) underwent ERCP within 30 days of cancer diagnosis. The proportion of patients who underwent ERCP declined from 57% in 2001 to 46% in 2015 (P for trend < .001). Among those who underwent ERCP, the mean number of ERCPs performed per patient over the year after diagnosis declined from 2.3 (standard deviation, 1.6) in 2001 to 1.8 (standard deviation, 1.1) in 2015 (P < .001). Despite decline in ERCP use, adjusted 1-year survival increased over time., Conclusions: In a SEER-Medicare population between 2001 and 2015, both the proportion of patients with unresectable pancreas cancer who underwent ERCP and the mean number of ERCPs per patient decreased over time. Survival improved over time despite decreased use of ERCP., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background & Aims: The prevalence and significance of digestive manifestations in coronavirus disease 2019 (COVID-19) remain uncertain. We aimed to assess the prevalence, spectrum, severity, and significance of digestive manifestations in patients hospitalized with COVID-19., Methods: Consecutive patients hospitalized with COVID-19 were identified across a geographically diverse alliance of medical centers in North America. Data pertaining to baseline characteristics, symptomatology, laboratory assessment, imaging, and endoscopic findings from the time of symptom onset until discharge or death were abstracted manually from electronic health records to characterize the prevalence, spectrum, and severity of digestive manifestations. Regression analyses were performed to evaluate the association between digestive manifestations and severe outcomes related to COVID-19., Results: A total of 1992 patients across 36 centers met eligibility criteria and were included. Overall, 53% of patients experienced at least 1 gastrointestinal symptom at any time during their illness, most commonly diarrhea (34%), nausea (27%), vomiting (16%), and abdominal pain (11%). In 74% of cases, gastrointestinal symptoms were judged to be mild. In total, 35% of patients developed an abnormal alanine aminotransferase or total bilirubin level; these were increased to less than 5 times the upper limit of normal in 77% of cases. After adjusting for potential confounders, the presence of gastrointestinal symptoms at any time (odds ratio, 0.93; 95% CI, 0.76-1.15) or liver test abnormalities on admission (odds ratio, 1.31; 95% CI, 0.80-2.12) were not associated independently with mechanical ventilation or death., Conclusions: Among patients hospitalized with COVID-19, gastrointestinal symptoms and liver test abnormalities were common, but the majority were mild and their presence was not associated with a more severe clinical course., (Copyright © 2021 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Objective: While single-use and detachable-tip duodenoscopes have been recently developed to overcome risks of infection transmission, there are no reliable tools to objectively assess their technical performance. We evaluated the reliability and validity of a newly developed tool to assess the technical performance of reusable duodenoscopes., Methods: An assessment tool was developed to measure duodenoscope performance based on three distinct criteria: maneuverability, mechanical/imaging characteristics and ability to perform requisite interventions. The assessment tool was tested prospectively on duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures at nine academic medical centers over a 6-month period. The main outcome was reliability of the duodenoscope assessment tool, which was estimated using Cronbach's coefficient alpha (α). The secondary outcome was validity of the assessment tool., Results: The assessment tool evaluated technical performance of reusable duodenoscopes in 1080 ERCP procedures. Indications were biliary in 92.8% and pancreatic in 7.2% procedures. The overall Cronbach's coefficient α for maneuverability was 0.81, assessment of mechanical/imaging characteristics was 0.92, and ability to perform requisite interventions was 0.87. On multiple linear regression analysis, prolonged procedure duration, older patient age and pancreatic interventions were significantly positively associated with higher (worse) scores., Conclusions: The newly developed assessment tool appears reliable and valid for evaluating the technical performance of duodenoscopes. Registration: ClinicalTrials.gov Identifier: NCT04004533., (© 2020 Japan Gastroenterological Endoscopy Society.)

Percutaneous transhepatic biliary drainage (PTBD) and endoscopic retrograde cholangiopancreatography (ERCP) are widely accepted but competing approaches for the management of malignant obstruction at the hilum of the liver. ERCP is favored in the United States on the basis of high success rates for non-hilar indications, the perceived safety and superior tissue sampling capability of ERCP relative to PTBD, and the avoidance of external drains that are undesirable to patients. A recent randomized controlled trial (RCT) comparing the 2 modalities in patients with resectable hilar cholangiocarcinoma was terminated prematurely because of higher mortality in the PTBD group. 1 In contrast, most observational data suggest that PTBD is superior for achieving complete drainage. 2-6 Because the preferred procedure remains uncertain, we aimed to compare PTBD and ERCP as the primary intervention in patients with cholestasis due to malignant hilar obstruction (MHO)., (Copyright © 2021 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background and Aims: The accurate measurement of technical skill in ERCP is essential for endoscopic training, quality assurance, and coaching of this procedure. Hypothesizing that technical skill can be measured by analysis of ERCP videos, we aimed to develop and validate a video-based ERCP skill assessment tool., Methods: Based on review of procedural videos, the task of ERCP was deconstructed into its basic components by an expert panel that developed an initial version of the Bethesda ERCP Skill Assessment Tool (BESAT). Subsequently, 2 modified Delphi panels and 3 validation exercises were conducted with the goal of iteratively refining the tool. Fully crossed generalizability studies investigated the contributions of assessors, ERCP performance, and technical elements to reliability., Results: Twenty-nine technical elements were initially generated from task deconstruction. Ultimately, after iterative refinement, the tool comprised 6 technical elements and 11 subelements. The developmental process achieved consistent improvements in the performance characteristics of the tool with every iteration. For the most recent version of the tool, BESAT-v4, the generalizability coefficient (a reliability index) was .67. Most variance in BESAT scores (43.55%) was attributed to differences in endoscopists' skill, indicating that the tool can reliably differentiate between endoscopists based on video analysis., Conclusions: Video-based assessment of ERCP skill appears to be feasible with a novel instrument that demonstrates favorable validity evidence. Future steps include determining whether the tool can discriminate between endoscopists of varying experience levels and predict important outcomes in clinical practice., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. All rights reserved.)

Background and Aim: Enteral stents (ES) have emerged as first-line therapy for the treatment of malignant gastric outlet obstruction (GOO). Stent occlusion arising from tissue ingrowth may require endoscopic or surgical reintervention. The objective of this study was to compare rates of reintervention following palliative ES for patients with GOO due to pancreatic adenocarcinoma (PDAC) versus other malignant etiologies., Methods: Patients who had undergone ES for palliation of malignant GOO between 2009 and 2018 were retrospectively identified and demographic, clinical, and procedural data were collected. Primary outcome was procedural reintervention for recurrent symptomatic GOO following ES placement., Results: Forty-three patients were included in the study cohort. 62.8% (27/43) of patients had PDAC while 37.2% (16/43) of patients had other malignant etiologies. 11.6% (5/43) of patients were alive at follow-up. Thirty-day and 90-day mortality rates were 22.8% and 70.7% for PDAC and 25% and 56.3% for other malignant etiologies, respectively. Seven patients required reintervention for symptomatic GOO: 14.3% (1/7) had PDAC and 85.7% (6/7) had GOO due to other malignancy (P < .01). Ninety-six percent (26/27) of patients with PDAC required no further intervention for GOO prior to death or end of follow-up. On multivariate analysis, patients with PDAC were significantly less likely to require reintervention than patients with other malignant etiologies (OR 0.064, 95% CI 0.01-0.60)., Conclusion: ES offer durable symptom palliation without requirement for reintervention for the overwhelming majority of patients with malignant GOO due to PDAC. Reintervention rates are higher following ES placement for GOO due to other malignant etiologies and future study may be needed to define the optimal palliative intervention for this group of patients.

Background and study aims  Plastic biliary stents are standard therapy for treatment of post-cholecystectomy bile leaks. An increasing proportion of patients now undergo subtotal cholecystectomy and are at perceived risk for high-grade bile leak. Data are limited regarding the optimal endoscopic therapy following subtotal cholecystectomy. The aim of this study was to compare outcomes of endoscopic plastic stent therapy for treatment of bile leak following total vs subtotal cholecystectomy. Patients and methods  A retrospective cohort of patients with bile leak following cholecystectomy and treated with biliary stent was identified from an institutional database. Primary outcome was defined as cholangiographic resolution of leak at follow-up endoscopic retrograde cholangiopancreatography (ERCP). Results  Sixty-one subjects met study inclusion criteria, 27 following total cholecystectomy and 34 following subtotal cholecystectomy. A single plastic biliary stent was placed in 87 % of subjects (53/61), while a fully covered self-expanding metal stent (FCSEMS) was placed in 13 % (8/61). Leak resolution was evident at first follow-up ERCP in 96 % of subjects (26/27) who had undergone total cholecystectomy and 91 % of subjects (31/34) who had undergone subtotal cholecystectomy ( P  = 0.25). Among subjects who had received a plastic stent at index ERCP, leak resolution was evident at first follow-up ERCP in 96 % (23/24) of those who had undergone total cholecystectomy and 90 % (26/29) of those who had undergone subtotal cholecystectomy ( P  = 0.62). Conclusions  High rates of leak resolution can be achieved with placement of a single plastic biliary stent for treatment of post-cholecystectomy bile leaks, including after subtotal cholecystectomy., Competing Interests: Competing interests Dr. Yachimski is a consultant for Boston Scientific., (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 commecial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background and Aims: Endoscopic intervention has emerged as a first-line option for management of symptomatic pancreatic necrosis, yet endoscopic debridement is limited by the lack of dedicated endoscopic tools intended for this purpose. The objectives of this study were to design and build a prototype necrosectomy device compatible for use with a flexible endoscope and capable of selective tissue fragmentation, and to test the prototype in benchtop and porcine models., Methods: A novel prototype, named the waterjet necrosectomy device (WAND), was designed and developed, consisting of a single-use disposable endoscopic waterjet instrument capable of waterjet selection and independent tip articulation while fitting through a 2.8-mm working channel of a standard adult upper GI endoscope. Benchtop, ex vivo, and in vivo (porcine) testing was performed in the initial stages of investigation., Results: The WAND was capable of delivering a continuous waterjet force with a surface pressure of 0.72 bar at a flow rate of 0.37 L/minute. In phase 1 of testing, the WAND was able to achieve complete fragmentation of gelatin as a surrogate for pancreatic necrosis in benchtop testing. In phase 2 of testing, the WAND was able to achieve complete fragmentation of freshly explanted human pancreatic necrosis. In phase 3 of testing for safety in fresh necropsy swine, use of the WAND resulted in no significant tissue trauma, even when irrigation was applied at closer proximity and for more extended duration than would be anticipated in clinical use., Conclusion: The WAND prototype delivers irrigation capable of fragmenting necrotic debris ex vivo and avoiding trauma to healthy nontarget tissue. Planning is underway for first-in-human studies to assess the efficacy and safety of the WAND for endoscopic pancreatic necrosectomy., (Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

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

Introduction: Lumen apposing metal stents (LAMS) have been used increasingly for drainage of pancreatic fluid collections (PFC). We present an international, multicenter study evaluating the safety and efficacy of LAMS in PFCs., Methods: Consecutive patients undergoing LAMS placement for PFC at 12 international centers were included (ClinicalTrials.gov NCT01522573). Demographics, clinical history, and procedural details were recorded. Technical success was defined as successful LAMS deployment. Clinical success was defined as PFC resolution at three-month follow-up., Results: 192 patients were included (140 males (72.9%), mean-age 53.8 years), with mean follow-up of 4.2 months ± 3.8. Mean PFC size was 11.9 cm (range 2-25). The median number of endoscopic interventions was 2 (range 1-14). Etiologies for PFC were gallstone (n = 82, 42.7%), alcohol (n = 50, 26%), idiopathic (n = 26, 13.5%), and other (n = 34, 17.7%). Technical success was achieved in 189 patients (98.4%). Clinical success was observed in 125 of 135 patients (92.6%). Adverse events included bleeding (n = 11, 5.7), infection (n = 2, 1%), and perforation (n = 2, 1%). Three or more endoscopy sessions were a positive predictor for PFC resolution and the only significant predictor for AEs., Conclusion: LAMS has a high technical and clinical success rate with a low rate of AEs. PFC drainage via LAMS provides a minimally invasive, safe, and efficacious procedure for PFC resolution., (Copyright © 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Larger caliber lumen-apposing stents (LAMSs) have been increasingly used in the management of pancreatic fluid collections, specifically when solid debris is present; however, their advantages over smaller caliber plastic stents in the management of pancreatic pseudocysts are unclear. The aim of this study was to investigate the safety and efficacy of LAMS specifically in the management of pancreatic pseudocysts compared with double-pigtail plastic stents (DPPSs)., Methods: We performed a multicenter, international, retrospective study between January 2012 and August 2016. A total of 205 patients with a diagnosis of pancreatic pseudocysts were included, 80 patients received LAMSs and 125 received DPPSs. Measured outcomes included clinical success, technical success, adverse events, stent dysfunction, pancreatic pseudocyst recurrence, and need for surgery., Results: Technical success was similar between the LAMS and the DPPS groups (97.5 % vs. 99.2 %; P  = 0.32). Clinical success was higher for LAMSs than for DPPSs (96.3 % vs. 87.2 %; P  = 0.03). While the need for surgery was similar between the two groups (1.3 % vs. 4.9 %, respectively; P  = 0.17), the use of percutaneous drainage was significantly lower in the LAMS group (1.3 % vs. 8.8 %; P  = 0.03). At 6-month follow-up, the recurrence rate was similar between the groups (6.7 % vs 18.8 %, respectively; P  = 0.12). The rate of adverse events was significantly higher in the DPPS group (7.5 % vs. 17.6 %; P  = 0.04). There was no difference in post-procedure mean length of hospital stay (6.3 days [standard deviation 27.9] vs. 3.7 days [5.7]; P  = 0.31)., Conclusion: When compared to DPPSs, LAMSs are a safe, feasible, and effective modality for the treatment of pancreatic pseudocysts and are associated with a higher rate of clinical success, shorter procedure time, less need for percutaneous interventions, and a lower overall rate of adverse events., Competing Interests: S. Friedland is a consultant for Boston Scientific and C2 Therapeutics; T. Stevens is a speaker and consultant for Boston Scientific and a speaker for AbbVie pharmaceuticals; C. J. DiMaio is a consultant for Boston Scientific and Medtronic; L. H. Jamil is a consultant for Aries pharmaceutical; P. S. Yachimski is a consultant for Boston Scientific; J. Nieto is a consultant for Boston Scientific; V. Kumbhari is a consultant for ReShape Life Sciences, Apollo Endosurgery, Medtronic, and Boston Scientific, and has received consulting fees from Pentax Medical and C2 Therapeutics; V. Singh is a consultant for Abbvie, D-Pharm, and Santarus; E. J. Shin is a consultant for Boston Scientific and C2 Therapeutics; M. Khashab is a consultant for Boston Scientific and Olympus, and is also on the medical advisory board for Boston Scientific and Olympus. All other co-authors have no conflict of interest disclosures., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background & Aims: It is a challenge to accurately assess pancreatic cystic lesions (PCLs) and determine their risk. We compared the yield of tissue acquired with endoscopic ultrasound (EUS)-guided microforceps (through the needle tissue biopsy [TTNB]) with that of samples collected by EUS-guided fine-needle-aspiration (EUS-FNA), and the accuracy of analyses of each sample type in the diagnosis of mucinous PCLs., Methods: We performed a prospective open-label study of 114 consecutive adults (56.1% women; mean age, 64.2 y) undergoing EUS-FNA evaluation of PCLs (mean size, 35 mm) at 7 centers, from June 20, 2016, through August 31, 2018. Samples were collected from each cyst by FNA and microforceps; samples collected by FNA were analyzed by cytology and samples collected by TTNB were analyzed by histology. Acquisition yield was defined as the percentage of specimens collected that were adequate for cytologic or histologic analysis. Diagnoses of mucinous cysts were made based on identification of pancreatic mucinous epithelium by cytology analysis of FNA samples or histologic analysis of TTNB samples. Surgical specimens were used as the reference standard when available., Results: The EUS-guided microforceps were successfully inserted into 97.4% (111 of 114) of PCLs. Tissue acquisition yield was significantly higher with TTNB (95 of 114; 83.3%) than FNA (43 of 114; 37.7%) (P < .001). Sixty-one PCLs were determined to be mucinous based on TTNB analysis (53.5%) vs 11 with FNA analysis (9.6%) (P < .001). Among PCLs categorized as equivocal, based on the level of carcinoembryonic antigen, TTNB analysis found 50% (41 of 82) to be mucinous and FNA analysis found 8.5% (7 of 82) to be mucinous (P < .001). Findings from analyses of samples collected by TTNB were 100% concordant with findings from histologic analysis of surgical specimens (14 of 14), whereas only 3 of 14 findings from analysis of samples collected by FNA were in agreement with findings from surgical specimens (21.4%) (P < .001). Four of 5 mucinous PCLs with advanced neoplasia (80%) were detected with TTNB compared with none with FNA (P = .04). Self-limited intracystic bleeding occurred in 7 patients (6.1%), and acute pancreatitis in 6 patients (5.3%)., Conclusions: In a multicenter prospective study of patients undergoing EUS-FNA for evaluation of PCLs, we found TTNB collection of tissues for histologic analysis to be safe and feasible, with an acquisition yield of 83.3%. Histologic analysis of samples collected by TTNB identified a larger proportion of mucinous PCLs compared with cytologic analysis of samples collected by FNA-even among samples categorized as equivocal, based on the level of carcinoembryonic antigen. More samples collected by TTNB than FNA were found to have advanced neoplasia. Clinicaltrials.gov no: NCT02979509., (Copyright © 2019 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Minimum EUS and ERCP volumes that should be offered per trainee in "high quality" advanced endoscopy training programs (AETPs) are not established. We aimed to define the number of procedures required by an "average" advanced endoscopy trainee (AET) to achieve competence in technical and cognitive EUS and ERCP tasks to help structure AETPs., Methods: American Society for Gastrointestinal Endoscopy (ASGE)-recognized AETPs were invited to participate; AETs were graded on every fifth EUS and ERCP examination using a validated tool. Grading for each skill was done using a 4-point scoring system, and learning curves using cumulative sum analysis for overall, technical, and cognitive components of EUS and ERCP were shared with AETs and trainers quarterly. Generalized linear mixed-effects models with a random intercept for each AET were used to generate aggregate learning curves, allowing us to use data from all AETs to estimate the average learning experience for trainees., Results: Among 62 invited AETPs, 37 AETs from 32 AETPs participated. Most AETs reported hands-on EUS (52%, median 20 cases) and ERCP (68%, median 50 cases) experience before starting an AETP. The median number of EUS and ERCPs performed per AET was 400 (range, 200-750) and 361 (range, 250-650), respectively. Overall, 2616 examinations were graded (EUS, 1277; ERCP-biliary, 1143; pancreatic, 196). Most graded EUS examinations were performed for pancreatobiliary indications (69.9%) and ERCP examinations for ASGE biliary grade of difficulty 1 (72.1%). The average AET achieved competence in core EUS and ERCP skills at approximately 225 and 250 cases, respectively. However, overall technical competence was achieved for grade 2 ERCP at about 300 cases., Conclusion: The thresholds provided for an average AET to achieve competence in EUS and ERCP may be used by the ASGE and AETPs in establishing the minimal standards for case volume exposure for AETs during their training. (Clinical trial registration number: NCT02509416.)., (Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Each year choledocholithiasis results in biliary obstruction, cholangitis, and pancreatitis in a significant number of patients. The primary treatment, ERCP, is minimally invasive but associated with adverse events in 6% to 15%. This American Society for Gastrointestinal Endoscopy (ASGE) Standard of Practice (SOP) Guideline provides evidence-based recommendations for the endoscopic evaluation and treatment of choledocholithiasis. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework was used to rigorously review and synthesize the contemporary literature regarding the following topics: EUS versus MRCP for diagnosis, the role of early ERCP in gallstone pancreatitis, endoscopic papillary dilation after sphincterotomy versus sphincterotomy alone for large bile duct stones, and impact of ERCP-guided intraductal therapy for large and difficult choledocholithiasis. Comprehensive systematic reviews were also performed to assess the following: same-admission cholecystectomy for gallstone pancreatitis, clinical predictors of choledocholithiasis, optimal timing of ERCP vis-à-vis cholecystectomy, management of Mirizzi syndrome and hepatolithiasis, and biliary stent therapy for choledocholithiasis. Core clinical questions were derived using an iterative process by the ASGE SOP Committee. This body developed all recommendations founded on the certainty of the evidence, balance of risks and harms, consideration of stakeholder preferences, resource utilization, and cost-effectiveness., (Copyright © 2019. Published by Elsevier Inc.)

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.

Purpose of the Review: Pancreatic walled-off necrosis (WON) may require adjunctive direct endoscopic necrosectomy (DEN) following transmural stent placement. DEN is performed immediately or delayed in relation to index endoscopy. There is currently no consensus on the optimal timing of DEN. We review the most recent literature addressing each practice., Recent Findings: Some expert opinion prefer delayed DEN; however, recent data reveal immediate DEN may reduce the number of endoscopic sessions required for successful clinical resolution of WON. Future studies are needed to determine the optimal timing for DEN following transmural stent placement for the management of WON.

Background & Aims: It is unclear whether participation in competency-based fellowship programs for endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) results in high-quality care in independent practice. We measured quality indicator (QI) adherence during the first year of independent practice among physicians who completed endoscopic training with a systematic assessment of competence., Methods: We performed a prospective multicenter cohort study of invited participants from 62 training programs. In phase 1, 24 advanced endoscopy trainees (AETs), from 20 programs, were assessed using a validated competence assessment tool. We used a comprehensive data collection and reporting system to create learning curves using cumulative sum analysis that were shared with AETs and trainers quarterly. In phase 2, participating AETs entered data into a database pertaining to every EUS and ERCP examination during their first year of independent practice, anchored by key QIs., Results: By the end of training, most AETs had achieved overall technical competence (EUS 91.7%, ERCP 73.9%) and cognitive competence (EUS 91.7%, ERCP 94.1%). In phase 2 of the study, 22 AETs (91.6%) participated and completed a median of 136 EUS examinations per AET and 116 ERCP examinations per AET. Most AETs met the performance thresholds for QIs in EUS (including 94.4% diagnostic rate of adequate samples and 83.8% diagnostic yield of malignancy in pancreatic masses) and ERCP (94.9% overall cannulation rate)., Conclusions: In this prospective multicenter study, we found that although competence cannot be confirmed for all AETs at the end of training, most meet QI thresholds for EUS and ERCP at the end of their first year of independent practice. This finding affirms the effectiveness of training programs. Clinicaltrials.gov ID NCT02509416., (Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Objectives: Double-guidewire cannulation (DGC) for selective biliary access has been associated with increased risk of post-ERCP pancreatitis (PEP) in patients who have had pancreatic duct (PD) contrast injection. The objective of this study was to determine whether DGC increases PEP risk in standard risk individuals when controlling for procedural aspects such as PD contrast injection., Methods: Consecutive adults with native papillae who underwent endoscopic retrograde cholangiopancreatography from 2009 to 2014 were retrospectively identified, and clinical data were collected., Results: There were 879 subjects who met inclusion criteria. Increased incidence of PEP was observed after DGC (18% with DGC vs 4% without DGC, P < 0.005). Additional factors associated with increased PEP risk included the following: PD contrast injection, PD wire cannulations, and biliary stent placement. The association between DGC and increased PEP risk remained significant in a multivariate model controlling for age, sex, PD contrast injection, biliary sphincterotomy, biliary stent placement, and rectal indomethacin administration (odds ratio = 2.87, 95% confidence interval = 1.23-6.36)., Conclusions: Double-guidewire cannulation is associated with increased risk of PEP when controlling for confounding variables. Prospective studies should be undertaken to assess whether prophylactic interventions reduce risk of PEP after DGC in an average-risk population.

Endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) are the mainstays of interventional endoscopic practice. EUS occupies a central role in the diagnosis of pancreatobiliary neoplasms and offers a platform for a wide range of direct tumor therapies. Initial steps have demonstrated the feasibility of such applications in animal models and pilot studies. Larger clinical trials and incorporation of EUS-based therapies into cooperative cancer studies might demonstrate an impact in the clinical prognosis of patients with pancreatic cancer. ERCP plays an important role in elucidating indeterminate biliary strictures and in treating patients with malignant biliary obstruction who are symptomatic or have borderline-resectable or unresectable disease. ERCP-directed ablative therapies enable neoadjuvant and palliative intervention in patients with malignant biliary obstruction, in particular perihilar cholangiocarcinoma. Additional comparative, multicenter studies are needed to better understand the safety and efficacy of endobiliary brachytherapy, photodynamic therapy, and radiofrequency ablation in patients with pancreatobiliary malignancies., (Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background: The optimal approach to the drainage of malignant obstruction at the liver hilum remains uncertain. We aim to compare percutaneous transhepatic biliary drainage (PTBD) to endoscopic retrograde cholangiography (ERC) as the first intervention in patients with cholestasis due to suspected malignant hilar obstruction (MHO)., Methods: The INTERCPT trial is a multi-center, comparative effectiveness, randomized, superiority trial of PTBD vs. ERC for decompression of suspected MHO. One hundred and eighty-four eligible patients across medical centers in the United States, who provide informed consent, will be randomly assigned in 1:1 fashion via a web-based electronic randomization system to either ERC or PTBD as the initial drainage and, if indicated, diagnostic procedure. All subsequent clinical interventions, including crossover to the alternative procedure, will be dictated by treating physicians per usual clinical care. Enrolled subjects will be assessed for successful biliary drainage (primary outcome measure), adequate tissue diagnosis, adverse events, the need for additional procedures, hospitalizations, and oncological outcomes over a 6-month follow-up period. Subjects, treating clinicians and outcome assessors will not be blinded., Discussion: The INTERCPT trial is designed to determine whether PTBD or ERC is the better initial approach when managing a patient with suspected MHO, a common clinical dilemma that has never been investigated in a randomized trial., Trial Registration: ClinicalTrials.gov, Identifier: NCT03172832 . Registered on 1 June 2017.

Background & Aims: On the basis of the Next Accreditation System, trainee assessment should occur on a continuous basis with individualized feedback. We aimed to validate endoscopic ultrasound (EUS) and endoscopic retrograde cholangiopancreatography (ERCP) learning curves among advanced endoscopy trainees (AETs) by using a large national sample of training programs and to develop a centralized database that allows assessment of performance in relation to peers., Methods: ASGE recognized training programs were invited to participate, and AETs were graded on ERCP and EUS exams by using a validated competency assessment tool that assesses technical and cognitive competence in a continuous fashion. Grading for each skill was done by using a 4-point scoring system, and a comprehensive data collection and reporting system was built to create learning curves by using cumulative sum analysis. Individual results and benchmarking to peers were shared with AETs and trainers quarterly., Results: Of the 62 programs invited, 20 programs and 22 AETs participated in this study. At the end of training, median number of EUS and ERCP performed/AET was 300 (range, 155-650) and 350 (125-500), respectively. Overall, 3786 exams were graded (EUS, 1137; ERCP-biliary, 2280; ERCP-pancreatic, 369). Learning curves for individual end points and overall technical/cognitive aspects in EUS and ERCP demonstrated substantial variability and were successfully shared with all programs. The majority of trainees achieved overall technical (EUS, 82%; ERCP, 60%) and cognitive (EUS, 76%; ERCP, 100%) competence at conclusion of training., Conclusions: These results demonstrate the feasibility of establishing a centralized database to report individualized learning curves and confirm the substantial variability in time to achieve competence among AETs in EUS and ERCP. ClinicalTrials.gov: NCT02509416., (Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Background and Study Aims:  The objective of this study was to assess patient involvement in decision-making, decision confidence, and decision regret among patients who had undergone endoscopic eradication therapy (EET) or esophagectomy for Barrett's esophagus (BE) associated neoplasia., Patients and Methods:  Patients with BE high grade dysplasia or intramucosal (T1a) adenocarcinoma who had undergone EET or esophagectomy were invited to complete a survey., Results:  The cohort included 50 subjects, 70 % (35/50) of whom had undergone EET and 30 % (15/50) of whom had undergone esophagectomy. Subjects who underwent esophagectomy were more likely to report post-treatment dysphagia (47 % vs 14 %, P  = 0.03), post-treatment dietary modification (73 % vs 6 %, P  < 0.0001), and were less likely to view their post-treatment health favorably. However, when asked whether they had selected the right treatment, a high degree of confidence was reported by both groups (mean 9.8 for EET vs 9.3 for esophagectomy on a 0 - 10 scale, P  = 0.12). In fact, 97 % (34/35) of EET patients and 80 % (12/15) of esophagectomy patients indicated they would select the same treatment option ( P  = 0.08)., Conclusions:  Patients who have undergone EET or surgery for BE neoplasia report a high degree of involvement in the decision-making process. Although EET patients report fewer symptom-specific outcomes, measures of decision confidence and decision regret do not differ between the two treatment groups.

Background and Aims: Anastomotic bile leaks are common after orthotopic liver transplant (OLT), and standard treatment consists of placement of a biliary endoprosthesis. The objectives of this study were to identify risk factors for refractory anastomotic bile leaks and to determine the morbidity associated with refractory bile leaks after OLT., Methods: Consecutive adult patients who underwent ERCP for treatment of post-OLT biliary adverse events between 2009 and 2014 at a high-volume transplant center were retrospectively identified. A refractory leak was defined as a bile leak that persisted after placement of a plastic biliary endoprosthesis and required repeat endoscopic or surgical intervention., Results: Forty-three subjects met study inclusion criteria. Median age was 57 years, and 36 (84%) subjects were men. Refractory bile leaks were diagnosed in 40% of subjects (17/43). Time-to-event analysis revealed an association between refractory bile leaks and the combined outcome of death, repeat transplant, or surgical biliary revision (hazard ratio, 3.78; 95% confidence interval, 1.25-11.45; P = .01). Hepatic artery disease was more common with refractory compared with treatment-responsive bile leaks (53% vs 8%, P = .001)., Conclusions: Refractory anastomotic bile leaks after liver transplantation are associated with decreased event-free survival. Hepatic artery disease is associated with refractory leaks. Large-scale prospective studies should be performed to define the optimal management of patients at risk for refractory bile leaks., (Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and study aims  Data on clinical outcomes of endoscopic drainage of debris-free pseudocysts (PDF) versus pseudocysts containing solid debris (PSD) are very limited. The aims of this study were to compare treatment outcomes between patients with PDF vs. PSD undergoing endoscopic ultrasound (EUS)-guided drainage via transmural stents. Patients and methods  Retrospective review of 142 consecutive patients with pseudocysts who underwent EUS-guided transmural drainage (TM) from 2008 to 2014 at 15 academic centers in the United States. Main outcome measures included TM technical success, treatment outcomes (symptomatic and radiologic resolution), need for endoscopic re-intervention at follow-up, and adverse events (AEs). Results  TM was performed in 90 patients with PDF and 52 with PSD. Technical success: PDF 87 (96.7 %) vs. PSD 51 (98.1 %). There was no difference in the rates for endoscopic re-intervention (5.5 % in PDF vs. 11.5 % in PSD; P =  0.33) or AEs (12.2 % in PDF vs. 19.2 % in PSD; P  = 0.33). Median long-term follow-up after stent removal was 297 days (interquartile range [IQR]: 59 - 424 days) for PDF and 326 days (IQR: 180 - 448 days) for PSD ( P  = 0.88). There was a higher rate of short-term radiologic resolution of PDF (45; 66.2 %) vs. PSD (21; 51.2 %) (OR = 0.30; 95 % CI: 0.13 - 0.72; P  = 0.009). There was no difference in long-term symptomatic resolution (PDF: 70.4 % vs. PSD: 66.7 %; P  = 0.72) or radiologic resolution (PDF: 68.9 % vs. PSD: 78.6 %; P  = 0.72) Conclusions  There was no difference in need for endoscopic re-intervention, AEs or long-term treatment outcomes in patients with PDF vs. PSD undergoing EUS-guided drainage with transmural stents. Based on these results, the presence of solid debris in pancreatic fluid collections does not appear to be associated with a poorer outcome.

Objectives: Successful outpatient colonoscopy (CLS) depends on many factors including the quality of a patient's bowel preparation. Although education on consumption of the pre-CLS purgative can improve bowel preparation quality, no study has evaluated dietary education alone. We have created an educational video on pre-CLS dietary instructions to determine whether dietary education would improve outpatient bowel preparation quality., Methods: A prospective randomized, blinded, controlled study of patients undergoing outpatient CLS was performed. All patients received a 4 l polyethylene glycol-based split-dose bowel preparation and standard institutional pre-procedure instructions. Patients were then randomly assigned to an intervention arm or to a no intervention arm. A 4-min educational video detailing clear liquid diet restriction was made available to patients in the intervention arm, whereas those randomized to no intervention did not have access to the video. Patients randomized to the video were provided with the YouTube video link 48-72 h before CLS. An attending endoscopist blinded to randomization performed the CLS. Bowel preparation quality was scored using the Boston Bowel Preparation Scale (BBPS). Adequate preparation was defined as a BBPS total score of ≥6 with all segment scores ≥2. Wilcoxon rank-sum and Pearson's χ 2 -tests were performed to assess differences between groups., Results: Ninety-two patients were randomized (video: n=42; control: n=50) with 47 total video views being tallied. There were no demographic differences between groups. There was no statistically significant difference in adequate preparation between groups (video=74%; control=68%; P=0.54)., Conclusions: The availability of a supplementary patient educational video on clear liquid diet alone was insufficient to improve bowel preparation quality when compared with standard pre-procedure instruction at our institution.

Background and Aims: The need for transpapillary drainage (TPD) in patients undergoing transmural drainage (TMD) of pancreatic fluid collections (PFCs) remains unclear. The aims of this study were to compare treatment outcomes between patients with pancreatic pseudocysts undergoing TMD versus combined (TMD and TPD) drainage (CD) and to identify predictors of symptomatic and radiologic resolution., Methods: This is a retrospective review of 375 consecutive patients with PFCs who underwent EUS-guided TMD from 2008 to 2014 at 15 academic centers in the United States. Main outcome measures included TMD and CD technical success, treatment outcomes (symptomatic and radiologic resolution) at follow-up, and predictors of treatment outcomes on logistic regression., Results: A total of 375 patients underwent EUS-guided TMD of PFCs, of which 174 were pseudocysts. TMD alone was performed in 95 (55%) and CD in 79 (45%) pseudocysts. Technical success was as follows: TMD, 92 (97%) versus CD, 35 (44%) (P = .0001). There was no difference in adverse events between the TMD (15%) and CD (14%) cohorts (P = .23). Median long-term (LT) follow-up after transmural stent removal was 324 days (interquartile range, 72-493 days) for TMD and 201 days (interquartile range, 150-493 days) (P = .37). There was no difference in LT symptomatic resolution (TMD, 69% vs CD, 62%; P = .61) or LT radiologic resolution (TMD, 71% vs CD, 67%; P = .79). TPD attempt was negatively associated with LT radiologic resolution of pseudocyst (odds ratio, 0.11; 95% confidence interval, 0.02-0.8; P = .03)., Conclusions: TPD has no benefit on treatment outcomes in patients undergoing EUS-guided TMD of pancreatic pseudocysts and negatively affects LT resolution of PFCs., (Copyright © 2016 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Objectives: Multiple endoscopic sessions may be necessary for treatment and surveillance of Barrett's esophagus (BE)-associated neoplasia. Adherence to an endoscopic therapeutic regimen is important for longitudinal management of BE. The objective of this study was to identify the factors associated with adherence to therapy for BE-associated neoplasia., Methods: We retrospectively identified patients with BE whom were referred to a tertiary center for endoscopic mucosal resection (EMR) or radiofrequency ablation (RFA) between 2009 and 2012. Demographic and clinical data were extracted from the medical record., Results: We had 69 subjects meet our inclusion criteria. Referral diagnosis was low-grade dysplasia in 9 (13%) subjects, high-grade dysplasia in 33 (48%) subjects and adenocarcinoma in 26 (38%) subjects. The majority (55%) lived more than 100 miles from the treatment center. The primary third-party payer was US Medicare for 54% of the subjects and private insurance for 36% of them; 45% of the subjects were seen in the clinic by the treating endoscopist, prior to endoscopic therapy and 71% underwent EMR as the initial treatment, while 29% underwent RFA without prior EMR. We found that 72% of subjects were adherent to therapy, including: 23 (33%) completing endoscopic therapy with documented post-treatment surveillance, 18 (26%) with ongoing endoscopic therapy, and 9 (13%) whom underwent esophagectomy. Subjects seen in gastroenterology clinical consultation were significantly more likely to demonstrate adherence than those referred for open access endoscopy (Lasso OR 2.31)., Conclusions: Patients seen in a clinical consultation prior to endoscopic therapy for BE-associated neoplasia were more likely to demonstrate treatment adherence, compared to patients referred for open-access endoscopy. A clinic visit prior to therapy may define expectations regarding treatment course and increase the likelihood of patient adherence.

Objectives: Symptom eradication in patients with Barrett's esophagus (BE) does not guarantee control of acid or duodenogastroesophageal reflux (DGER). Continued reflux of acid and/or DGER may increase risk of neoplastic progression and may decrease the likelihood of columnar mucosa eradication after ablative therapy. To date, no study has addressed whether both complete acid and DGER control is possible in patients with BE. This prospective study was designed to assess the effect of escalating-dose proton pump inhibitor (PPI) therapy on esophageal acid and DGER., Methods: Patients with BE (≥3 cm in length) underwent simultaneous ambulatory prolonged pH and DGER monitoring after at least 1 week off PPI therapy followed by testing on therapy after 1 month of twice-daily rabeprazole (20 mg). In those with continued acid and/or DGER, the tests were repeated after 1 month of double-dose (40 mg twice daily) rabeprazole. The primary study outcome was normalization of both acid and DGER. Symptom severity was assessed on and off PPI therapy employing a four-point ordinal scale., Results: A total of 29 patients with BE consented for pH monitoring, of whom 23 also consented for both pH and DGER monitoring off and on therapy (83% male; mean age 58 years; mean body mass index 29; mean Barrett's length 6.0 cm). Median (interquartile range) total % time pH <4 and bilirubin absorbance >0.14 off PPI therapy were 18.4 (11.7-20.0) and 9.7 (5.0-22.2), respectively. In addition, 26/29 (90%) had normalized acid and 18/23 (78%) had normalized DGER on rabeprazole 20 mg. Among those not achieving normalization on 20 mg twice daily, 3/3 (100%) had normalized acid and 4/5 (80%) had normalized DGER on rabeprazole 40 mg twice daily. All subjects had symptoms controlled on rabeprazole 20 mg twice daily. Univariate analysis found no predictor for normalization of physiologic parameters based on demographics., Conclusions: Symptom control does not guarantee normalization of acid and DGER at standard dose of twice-daily PPI therapy. Normalization of acid and DGER can be achieved in 79% of BE patients on rabeprazole 20 mg p.o. twice daily, and in the majority of the remainder at high-dose twice-daily PPI. In patients undergoing ablative therapy, pH or DGER monitoring may not be needed to ensure normalization of reflux if patients are treated with high-dose PPI therapy.