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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants who fulfill all the below criteria will be enrolled: 1. with naive papilla; 2. over 18 years; 3. undergoing ERCP with pancreatic guidewire-assisted technique for biliary access; 4. providing a signed, written informed consent.

Locations
Other Locations
China
Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Contact Information
Primary
Qiao Mei, MD
meiqiaomq@aliyun.com
8613865977696
Backup
Junjun Bao, MD
csbj01@aliyun.com
8613655697005
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 768
Treatments
Experimental: early pancreatic stent placement (EPSP)
a pancreatic stent will be placed immediately after endoscopic retrograde cholangiography (ERC) or endoscopic sphincterotomy (EST)
Other: 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
Sponsors
Collaborators: Anqing Municipal Hospital, Tongcheng People's Hospital of Anhui province, First Affiliated Hospital of Wannan Medical College, The First Affiliated Hospital of Bengbu Medical University, Fuyang people's hospital
Leads: The First Affiliated Hospital of Anhui Medical University

This content was sourced from clinicaltrials.gov