Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery (NCT07238296) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery
92 participantsStarted 2026-07-01
Plain-language summary
This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of prophylactic endoscopic sphincterotomy (ES) in frail patients unfit for cholecystectomy following an episode of acute biliary pancreatitis (ABP).
Eligible patients will be randomized in a 1:1 ratio to either prophylactic ES during the index admission or conservative treatment. The primary endpoint is the time from randomization to the first occurrence of a recurrent pancreatobiliary event within 12 months, including recurrent ABP, cholangitis, choledocholithiasis requiring endoscopic retrograde cholangiopancreatography (ERCP), or cholangiogenic liver abscess. Secondary outcomes include mortality, pancreatobiliary events requiring intensive care unit admission, post-ERCP complications, cholecystitis, and length of hospitalization.
A total of 92 patients will be enrolled. The trial will be led by the Institute of Pancreatic Diseases, Semmelweis University, Budapest, Hungary, and conducted in accordance with Good Clinical Practice.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. adult patients (above 18 years)
✓. naïve papilla
✓. evidence of AP based on the Atlanta criteria:
✓. high probability of a biliary etiology:
✓. patients unfit for surgery due to the attending physician's decision e.g. American Society of Anesthesiologists (ASA) class ≥ III; severe heart failure with reduced ejection fraction \<40%, severe uncontrolled hypertension, chronic kidney disease stage four or five
Exclusion criteria
✕. previous cholecystectomy
✕. previous endoscopic sphincterotomy or pancreatobiliary stenting
. ERCP is contraindicated, e.g. the procedure cannot be carried out safely due to the patient's comorbidities or physical status; high risk of bleeding or contraindication of the discontinuation of the anticoagulation therapy.
✕. ERCP is technically not feasible due to altered anatomy, e.g., total gastrectomy, Roux-en-Y gastric bypass anatomy