Early Pancreatic Stent Placement for Preventing PEP

Our aim is to compare early versus late pancreatic stent placement in preventing PEP among patients with naive papilla. The EVL trial will provide essential answers regarding the optimal timing of prophylactic pancreatic stent placement in PEP prevention.All patients with difficult biliary cannulation undergoing endoscopic retrograde cholangiopancreatography (ERCP) with pancreatic guidewire-assisted technique for biliary access will be told about the opportunity to participate in EVL research. In total, 768 patients will be randomly assigned (1:1) to two arms: (1) early pancreatic stent placement (EPSP) (a pancreatic stent will be placed immediately after endoscopic retrograde cholangiography (ERC) or endoscopic sphincterotomy (EST)) and (2) late pancreatic stent placement (LPSP) (a pancreatic stent will be placed after all completion of therapeutic biliary procedures, e.g. biliary stone removal or drainage).The primary outcome is the rate and severity of PEP. The secondary outcomes are hyperamylasemia, the rate of stenting success, and other ERCP-related adverse events (AEs).

NCT Number	NCT06250803
Lead Sponsor	The First Affiliated Hospital of Anhui Medical University Collaborators: The First Affiliated Hospital of Bengbu Medical University, Anqing Municipal Hospital, First Affiliated Hospital of Wannan Medical College, Tongcheng People's Hospital of Anhui province, Fuyang people's hospital
Conditions	Cholangiopancreatography, Endoscopic Rretrograde, Post-ERCP Pancreatitis
Enrollment	768 participants
Start Date	2024-04-01
Primary Completion	2026-03-01 (estimated)
Study Completion	2026-03-01 (estimated)
Updated on ClinicalTrials.gov	2025-03-13