Prophylactic endoscopic sphincterotomy in patients unfit for cholecystectomy after an acute biliary pancreatitis episode (PROSECCO): study protocol for an open-label, two-armed, randomised controlled trial.

introductionAcute pancreatitis is a major cause of gastrointestinal admissions, with an overall mortality of approximately 3%, and 30-55% of cases are biliary in origin. After acute biliary pancreatitis (ABP), elderly or frail patients who are unfit for cholecystectomy remain at high risk of recurrent biliary events and related complications. However, the efficacy of prophylactic endoscopic sphincterotomy (ES) in this patient population remains unclear. Therefore, this study aims to evaluate whether performing prophylactic ES after ABP can reduce mortality and readmissions for biliary events in patients unfit for cholecystectomy. METHODS AND ANALYSIS: This prospective, multicentre, open-label randomised controlled trial will be conducted in Hungary, with planned international expansion, to assess the efficacy of prophylactic ES in patients with ABP unfit for cholecystectomy. 92 patients will be randomised 1:1 to prophylactic ES or conservative treatment. An interim analysis will be conducted after 65% of the planned enrolment or once 60 patients have completed 12 month follow-up or have experienced a primary outcome event, whichever occurs first. ES will be performed in accordance with current guidelines. Eligible participants are adults with a high probability of biliary aetiology but without a current indication for urgent endoscopic retrograde cholangiopancreatography (ERCP). The primary endpoint is time from randomisation to first recurrent pancreatobiliary event within 12 months, including recurrent ABP, cholangitis, choledocholithiasis requiring ERCP or pyogenic liver abscess. Secondary endpoints are pancreatobiliary-related and all-cause mortality, as well as events requiring intensive care. Follow-up visits will take place at 3, 6, 9 and 12 months post-discharge. ETHICS AND DISSEMINATION: This study protocol was approved by the Scientific and Research Ethics Committee of the Medical Council (NNGYK/34436-6/2025). The findings will be disseminated through presentation at scientific meetings and publication in a highly recognised, peer-reviewed international journal. TRIAL REGISTRATION NUMBER: NCT07238296.