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Early Pancreatic Stent Placement for Preventing PEP — EVL  

Post-ERCP Pancreatitis Clinical Trial

Official title:
Early Versus Late Pancreatic Stent Placement for Preventing Post-ERCP Pancreatitis: a Multicentre, Randomised Trial

Clinical Trial Summary

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).

Clinical Trial Description

Patients with challenging biliary access using pancreatic guidewire-assisted method will be enrolled in the study. Recruitment will take place among individuals referred to the four participating centers for therapeutic biliary procedures. After obtaining signed consent forms, participants who meet all the inclusion criteria and have no exclusion criteria will be randomly grouped (with a 1:1 ratio) into EPSP and LPSP ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06250803
Study type Interventional
Source The First Affiliated Hospital of Anhui Medical University
Contact Qiao Mei, MD
Phone 8613865977696
Email meiqiaomq@aliyun.com
Status Not yet recruiting
Phase N/A
Start date March 1, 2024
Completion date March 1, 2026
View Details
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