Importance:Pancreas divisum is implicated as an obstructive cause for acute pancreatitis. Observational data suggest endoscopic retrograde cholangiopancreatography (ERCP) with minor papillotomy reduces the risk of pancreatitis episodes. Even though this endoscopic procedure is widely used in practice, clinical trials are lacking. Objective:To determine whether ERCP with minor papillotomy reduces the risk of acute pancreatitis among adults with unexplained acute recurrent pancreatitis and pancreas divisum. Design, Setting, and Participants:This multicenter, sham-controlled, double-blind randomized clinical trial enrolled adults with 2 or more episodes of acute pancreatitis and pancreas divisum. Adults with other etiologies for acute pancreatitis or concomitant chronic calcific pancreatitis were excluded. The trial was conducted between September 1, 2018, and August 30, 2024, at 21 referral centers in the US and Canada. Last follow-up occurred on February 15, 2025. Intervention:Participants were randomized in a 1:1 ratio to ERCP with minor papillotomy or sham ERCP. Main Outcomes and Measures:The primary outcome was development of acute pancreatitis more than 30 days after randomization as a time-to-event outcome. The secondary outcomes included acute pancreatitis episode frequency and development of chronic calcific pancreatitis, diabetes, and exocrine pancreatic dysfunction. Results:A total of 148 participants were randomized (mean age, 54 [SD, 19.5] years; 68.2% female; 95.3% non-Hispanic or Latino and 87.2% White; mean lifetime acute pancreatitis episodes, 3 [SD, 2]; mean duct diameter, 2.2 [SD, 1.3] mm) and followed up for a median of 34 months (IQR, 21.7-45.7 months). Of the 75 participants in the ERCP with minor papillotomy group, 26 (34.7%) developed acute pancreatitis compared with 32 of 73 participants (43.8%) in the sham ERCP group (adjusted hazard ratio, 0.83 [95% CI, 0.49 to 1.41]). The incidence rate ratio for acute recurrent pancreatitis episode frequency was 0.25 (95% CI, 0.18 to 0.34) in the ERCP with minor papillotomy group vs 0.30 (95% CI, 0.23 to 0.41) in the sham ERCP group. There were no between-group differences in frequency and incidence of chronic calcific pancreatitis (4.0% in the ERCP with minor papillotomy group vs 2.7% in the sham ERCP group; risk difference [RD], 0.01 [95% CI, -0.05 to 0.07]), diabetes (15.8% vs 12.8%, respectively; RD, 0.03 [95% CI, -0.13 to 0.19]), and exocrine pancreatic dysfunction (7.7% vs 17.2%; RD, -0.10 [95% CI, -0.27 to 0.08]). The adverse event of acute pancreatitis within 30 days of randomization occurred more frequently in the ERCP with minor papillotomy group (14.7%) vs the sham ERCP group (8.2%) (RD, 0.06 [95% CI, -0.04 to 0.17]). Conclusions and Relevance:Among patients with unexplained acute recurrent pancreatitis and pancreas divisum, ERCP with minor papillotomy does not reduce the risk of another episode of acute pancreatitis or related sequelae. Trial Registration:ClinicalTrials.gov Identifier: NCT03609944.

BACKGROUND:The incidence of duodenal neuroendocrine tumors (D-NETs) has been steadily rising. Endoscopic resection has become the preferred treatment option for smaller, localized lesions. We aimed to corroborate the efficacy and safety of endoscopic resection of D-NETs in a Western population and to evaluate treatment durability and disease course by examining long-term outcomes after resection. METHODS:This was a retrospective cohort study of patients who underwent endoscopic resection of a nonampullary D-NET from 2012 through 2020 at a single institution in the United States. Demographic, clinical, and procedural data were abstracted in duplicate and independent fashion. Outcomes were assessed through medical records review and follow-up phone calls. RESULTS:Over the study period, 58 patients underwent endoscopic resection of 59 D-NETs. Follow-up data were available in 85% of patients with a median follow-up duration of 23 months. Almost all D-NETs were located in the duodenal bulb, and all were biologically indolent. The mean size 6.6 mm (range: 1 to 27 mm). The most common resection technique was cap- or band-assisted endoscopic mucosal resection (73%). Negative resection margins were achieved in 78% of the sample. Delayed hemorrhage and perforation occurred in 5 and 6 patients, respectively; all but one were managed endoscopically. The presence of residual or recurrent neoplasm was identified at follow-up endoscopy in 10 patients and did not appear to be associated with resection margin status or endoscopic removal technique. No patients required surgical resection of a NET, were diagnosed with metastatic NET, or died as the result of their neuroendocrine tumor during follow-up. CONCLUSION:Endoscopic resection appears to be reasonably safe and durably effective in treating localized duodenal neuroendocrine tumors, but attention to endoscopic rescue of adverse events and to follow-up is necessary.

Introduction Surveillance of at-risk populations for pancreatic ductal adenocarcinoma (PDAC) is a potential strategy to reduce its incidence and improve its prognosis. However, there is considerable debate about who should participate and relatively little information about how people perceive different testing options. Methods Using the Health Belief Model as a framework, this qualitative, observational study including eleven focus groups and seven interviews, summarizes the knowledge, motivations, barriers and preferences for PDAC surveillance in underserved populations with low cancer screening rates and for high-risk individuals (HRI). Results HRIs have a high motivation to participate in PDAC screening and perceive few barriers to engage. Participants from underserved populations had little knowledge of PDAC and surveillance, but they were interested in surveillance for PDAC based on their perception of the benefits of cancer screenings. The main barriers for participation in PDAC surveillance programs were cost, distrust of the larger medical system, discomfort associated with the testing, lack of a provider’s recommendation, and fear of a positive result. These barriers varied based on a person’s race/ethnicity and geographic location (urban vs. rural). Preferences expressed by underserved populations suggest that tests for early PDAC detection will need to be accurate, no or low cost, minimally invasive, and convenient to access. There was a correlation between a person’s self-perceived susceptibility for PDAC and their willingness to tolerate more invasive and less convenient methods. In addition, participants were motivated to participate in early detection programs with clear guidelines accompanied by their doctor’s recommendations. Conclusion There appears to be an association between actual and perceived risk of PDAC and patient willingness to participate in an early detection program. For populations lower along the risk spectrum, there is limited knowledge about pancreatic cancer or its risk factors, and potentially significant barriers to participate in an early detection program if deemed eligible.

QuestionDoes endoscopic retrograde cholangiopancreatography (ERCP) with minor papillotomy reduce the risk of acute pancreatitis in patients with unexplained acute recurrent pancreatitis and pancreas divisum anatomy?FindingsIn this randomized trial including 148 individuals with unexplained acute recurrent pancreatitis and pancreas divisum followed up for a median of 34 months, ERCP with minor papillotomy did not significantly reduce the rate of acute pancreatitis during follow-up (34.7% vs 43.8% for sham ERCP; adjusted hazard ratio, 0.83 [95% CI, 0.49-1.41]). There was no between-group difference in acute pancreatitis episode frequency and development of chronic calcific pancreatitis, diabetes, or exocrine pancreatic dysfunction.MeaningAmong patients with unexplained acute recurrent pancreatitis and pancreas divisum, ERCP with minor papillotomy does not reduce the risk of another episode of acute pancreatitis or related sequelae. ImportancePancreas divisum is implicated as an obstructive cause for acute pancreatitis. Observational data suggest endoscopic retrograde cholangiopancreatography (ERCP) with minor papillotomy reduces the risk of pancreatitis episodes. Even though this endoscopic procedure is widely used in practice, clinical trials are lacking.ObjectiveTo determine whether ERCP with minor papillotomy reduces the risk of acute pancreatitis among adults with unexplained acute recurrent pancreatitis and pancreas divisum.Design, Setting, and ParticipantsThis multicenter, sham-controlled, double-blind randomized clinical trial enrolled adults with 2 or more episodes of acute pancreatitis and pancreas divisum. Adults with other etiologies for acute pancreatitis or concomitant chronic calcific pancreatitis were excluded. The trial was conducted between September 1, 2018, and August 30, 2024, at 21 referral centers in the US and Canada. Last follow-up occurred on February 15, 2025.InterventionParticipants were randomized in a 1:1 ratio to ERCP with minor papillotomy or sham ERCP.Main Outcomes and MeasuresThe primary outcome was development of acute pancreatitis more than 30 days after randomization as a time-to-event outcome. The secondary outcomes included acute pancreatitis episode frequency and development of chronic calcific pancreatitis, diabetes, and exocrine pancreatic dysfunction.ResultsA total of 148 participants were randomized (mean age, 54 [SD, 19.5] years; 68.2% female; 95.3% non-Hispanic or Latino and 87.2% White; mean lifetime acute pancreatitis episodes, 3 [SD, 2]; mean duct diameter, 2.2 [SD, 1.3] mm) and followed up for a median of 34 months (IQR, 21.7-45.7 months). Of the 75 participants in the ERCP with minor papillotomy group, 26 (34.7%) developed acute pancreatitis compared with 32 of 73 participants (43.8%) in the sham ERCP group (adjusted hazard ratio, 0.83 [95% CI, 0.49 to 1.41]). The incidence rate ratio for acute recurrent pancreatitis episode frequency was 0.25 (95% CI, 0.18 to 0.34) in the ERCP with minor papillotomy group vs 0.30 (95% CI, 0.23 to 0.41) in the sham ERCP group. There were no between-group differences in frequency and incidence of chronic calcific pancreatitis (4.0% in the ERCP with minor papillotomy group vs 2.7% in the sham ERCP group; risk difference [RD], 0.01 [95% CI, -0.05 to 0.07]), diabetes (15.8% vs 12.8%, respectively; RD, 0.03 [95% CI, -0.13 to 0.19]), and exocrine pancreatic dysfunction (7.7% vs 17.2%; RD, -0.10 [95% CI, -0.27 to 0.08]). The adverse event of acute pancreatitis within 30 days of randomization occurred more frequently in the ERCP with minor papillotomy group (14.7%) vs the sham ERCP group (8.2%) (RD, 0.06 [95% CI, -0.04 to 0.17]).Conclusions and RelevanceAmong patients with unexplained acute recurrent pancreatitis and pancreas divisum, ERCP with minor papillotomy does not reduce the risk of another episode of acute pancreatitis or related sequelae.Trial RegistrationClinicalTrials.gov Identifier: NCT03609944 This randomized clinical trial compares the use of endoscopic retrograde cholangiopancreatography (ERCP) with minor papillotomy vs a sham ERCP procedure for the treatment of patients with idiopathic acute pancreatitis with pancreas divisum.

Background and Study Aims Fully covered, self-expandable metal stents (FCSEMS) are used to treat biliary strictures. FCSEMS with transmural side holes may facilitate cystic duct drainage to mitigate risk of cholecystitis and impact other stent-related adverse events such as migration and occlusion. This study compared rates of premature stent occlusion and acute cholecystitis among patients with biliary strictures who underwent first-time placement of a FCSEMS with or without transmural side holes. Patient and Methods This was a retrospective cohort study of adults who underwent endoscopic retrograde cholangiopancreatography (ERCP) with FCSEMS between April 2022 to April 2025 for malignant or benign extrahepatic bile duct strictures. The primary outcome was premature bile duct occlusion. The secondary outcome was acute cholecystitis among patients with an intact gallbladder. Results Among 219 patients meeting enrollment criteria, 57 (26%) had side holes. The rate of premature stent occlusion was similar with transmural side holes (12%) vs. without (11%, HR 1.02, 95% CI 0.42-2.43, p = 0.96). Among patients with an intact gallbladder (n=129), acute cholecystitis rates were similar with side holes (6%) or without (4.8%, HR 1.01, 95% CI 0.22-4.5, p = 0.99). Conclusions In this preliminary single center retrospective study, FCSEMS stents with side holes did not reduce rates of premature bile duct stent occlusion or acute cholecystitis compared to FCSEMS without side holes. ### Competing Interest Statement Emily Jonica is a consultant for Boston Scientific and Olympus Medical. Jessica Yu is a consultant for Cook Medical. All other authors have no conflicts of interest to declare. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: IRB of Oregon Health and Sciences University gave ethical approval for this work I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors

Background and Aims:Shortage of specialists and distance to facility are known barriers associated with reduced colorectal cancer screening in rural America. Although data are sparse, rural patients are at risk for undergoing colectomy for a nonmalignant polyp due to lack of local expertise with advanced endoscopic resection techniques. We aim to study the feasibility and clinical outcomes of an endoscopic submucosal dissection (ESD) at a rural US health system. Methods:ESD was introduced in a planned manner at our community hospital that predominantly serves a rural population. Procedure data and clinical outcomes were reviewed for consecutive patients who underwent attempted ESD for colorectal premalignant and early-stage malignant lesions from February 2021 to January 2024. Results:Of 92 attempted ESDs, standard ESD technique was successful in 82 lesions (90.2%), while hybrid ESD-endoscopic mucosal resection technique was required for 9 lesions (9.8%) and 1 ESD was aborted. Forty-four (47.8%) lesions were in the right colon. For those who underwent standard ESD without hybrid technique, resection rates were en bloc 81 (98.7%), R0 62 (75.6%), and curative 58 (70.7%). Adverse events occurred in 4 (4.8%). There were no delayed perforations. Final pathology showed tubular or tubulovillous adenoma in 51 (62.2%), sessile serrated lesion in 2 (2.4%), high-grade dysplasia in 14 (17.1%), and adenocarcinoma in 15 (18.3%), with adenocarcinomas being staged T1 with low-risk features in 9 (11%) and ≥T1 with high-risk features in 6 (7.3%). Surveillance colonoscopy or surgical pathology was available in 44 (53.7%). Recurrent or residual polyp was noted in 1 (1.2%). Conclusion:ESD can be introduced at a community hospital with a high level of safety and efficacy.

Disconnected pancreatic duct (DPD) and the associated syndrome are increasingly recognized as complications of severe pancreatitis. Despite the increased appreciation for this disorder and its treatment, there remain many questions regarding definition, diagnosis, and management. We utilized the expertise of the U.S. Pancreatic Disease Study Group to address 7 important questions derived from review of the literature pertaining to DPD in the setting of endoscopic treatment for necrotizing pancreatitis. Seven important questions were derived and following review by each member, consensus was reached. The 7 questions, followed by recommendations, included the appropriate definition for the syndromes and the radiographic definition for diagnosis; the appropriate timing for evaluation for diagnosis; the ideal diagnostic method; the use of pancreatic duct stents in this syndrome; the utility and safety of double plastic stents following endoscopic transmural drainage; and the role of surgical therapy. Important diagnostic and therapeutic questions were derived, which should be useful for the management of these patients as well as important research questions going forward.

BACKGROUND AND AIMS:ERCP carries potential for serious adverse events, and there is risk for unplanned health encounters after the procedure. The primary objective of this study was to identify the rate of 30-day hospital admission after outpatient ERCP in patients at elevated risk for post-ERCP pancreatitis based on patient- and procedure-related risk factors. We also explored whether pancreatitis rates and lengths of hospital stay differ with delayed hospitalization (versus admission immediately after ERCP) and identified factors associated with 30-day hospital admission. METHODS:High-risk patients in the Stent Versus Indomethacin trial who underwent outpatient ERCP were identified. The primary outcome was hospital admission within 30 days after outpatient ERCP. Patient and procedural factors associated with 30-day hospital admission were explored by means of univariable analysis followed by multivariable analysis, controlling for potential known confounders. RESULTS:Among 768 patients at high risk for post-ERCP pancreatitis who underwent outpatient ERCP and were discharged home, 21.9% required hospitalization within 30 days. Compared with patients who underwent outpatient ERCP but were admitted immediately to the hospital after the procedure, patients who were discharged after ERCP and admitted later had a higher incidence of post-ERCP pancreatitis (40.5% vs 30.9%; P = .04), moderate to severe post-ERCP pancreatitis (24.4% vs 13.8%; P < .01), and longer length of hospital stay (6.2 d vs 3.7 d; P < .001). Factors associated with 30-day hospitalization included patient age (odds ratio [OR], 0.98; 95% CI, 0.97-0.99), biliary stent placement (OR, 1.62; 95% CI, 1.05-2.48), and attempt at pancreatic duct cannulation (OR, 1.64; 95% CI, 1.02-2.64). CONCLUSIONS:High-risk patients who undergo outpatient ERCP and are discharged home are at considerable risk for hospital admission within 30 days and have an increased rate of pancreatitis and longer length of hospital stay compared with outpatients admitted to the hospital immediately after ERCP, and some factors may predict this outcome. These findings should influence decision making and informed consent when electing to proceed with high-risk ERCP, recognizing that patients with sphincter of Oddi dysfunction were over-represented in this cohort, which may limit generalizability to a typical ERCP practice.