Endoscopy 2025; 57(S 02): S624-S625
DOI: 10.1055/s-0045-1806631
Abstracts | ESGE Days 2025
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Prophylactic endoscopic sphincterotomy in patients unfit for cholecystectomy after an acute biliary pancreatitis episode – study protocol for an open-label, two-armed, randomized controlled trial

E Tari
1   Centre for Translational Medicine, Semmelweis University, Budapest, Hungary
2   First Department of Internal Medicine, Fejér County Szent György University Teaching Hospital, Székesfehérvár, Hungary
,
L Czakó
3   First Department of Internal Medicine, University of Szeged, Szeged, Hungary
,
Á Vincze
4   Division of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, pécs, Hungary
,
B Erőss
1   Centre for Translational Medicine, Semmelweis University, Budapest, Hungary
5   Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary
6   Institute of Pancreatic Diseases, Semmelweis University, Budapest, Hungary
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Aims Acute pancreatitis is a leading cause of gastrointestinal hospital admissions, with a mortality rate of 3% [1]. In Western countries, 30-55% of cases are caused by gallstones or sludge, known as biliary pancreatitis [2]. After acute biliary pancreatitis (ABP), patients are at risk of recurrent episodes or other biliary complications, such as acute cholecystitis or cholangitis, which contribute to high hospital readmission rates [3]. Although cholecystectomy is recommended to reduce recurrence, it is often unsuitable for elderly or frail patients with significant comorbidities [4]. The efficacy of prophylactic endoscopic sphincterotomy (ES) in preventing recurrent pancreatobiliary events in this population remains uncertain. This study aims to provide strong evidence on the safety and efficacy of prophylactic ES in frail patients unfit for cholecystectomy post-ABP, hypothesizing that it will reduce mortality and recurrent biliary events.

Methods A prospective, multicenter, open-label, two-armed RCT with a superiority study design will be conducted. The study protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement [5]. Study participants will be randomly assigned to group A ("prophylactic ES") and group B ("conservative treatment") in a 1:1 ratio, with randomization stratified by participating centers. Each arm will include 47 participants. An interim analysis will be conducted after 50% of the participants have been enrolled to reassess the estimated sample size and evaluate the collected data. ES procedures will be performed in accordance with the European Society of Gastrointestinal Endoscopy (ESGE) Guidelines [6]. Both per-protocol and intention-to-treat analyses will be conducted, with the final analysis prioritizing the intention-to-treat approach.

Results The study will include adult patients with a high probability of biliary etiology who are considered unfit for cholecystectomy by the attending physician. The primary outcome will be a composite endpoint of recurrent pancreatobiliary events within 12 months, including cholangitis, recurrent ABP, choledocholithiasis requiring endoscopic retrograde cholangiopancreatography (ERCP), and pyogenic liver abscess. Secondary outcomes will include pancreatobiliary-related and all-cause mortality rates, as well as the number of pancreatobiliary events requiring intensive care unit admission. Eligible patients must lack a clear indication for ERCP per current guidelines, such as cholangitis or visible common bile duct stones on imaging. Follow-up will occur at 3, 6, 9, and 12 months post-discharge.

Conclusions This study is designed to determine whether a prophylactic ES, after ABP, leads to a reduction of mortality and readmissions for biliary events in patients unfit for cholecystectomy.



Publication History

Article published online:
27 March 2025

© 2025. European Society of Gastrointestinal Endoscopy. All rights reserved.

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