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Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery

Study acronym: PROSECCO
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: Jul 1, 2026 to Sep 3, 2026v3
  2. Primary completion date: Nov 1, 2026 to Jul 1, 2028
    • Start date: Jan 1, 2026 to Jul 1, 2026
    • Study completion date: Nov 1, 2027 to Jul 1, 2028
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07238296
Lead Sponsor Semmelweis University
Conditions
(from sponsor)		 Acute Biliary Pancreatitis
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov