Actively Recruiting
Early Pancreatic Stent Placement for Preventing PEP
Led by The First Affiliated Hospital of Anhui Medical University · Updated on 2025-03-13
768
Participants Needed
2
Research Sites
99 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Anhui Medical University
Lead Sponsor
T
The First Affiliated Hospital of Bengbu Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Early Pancreatic Stent Placement for Preventing PEP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a naive papilla (no prior papilla treatment)
- Are 18 years of age or older
- Undergoing ERCP with pancreatic guidewire-assisted technique for biliary access
- Provide signed, written informed consent
You will not qualify if you...
- Main papilla is unreachable
- Have surgically altered gastrointestinal anatomy
- Have current acute pancreatitis
- Have biliary cannulation over pancreatic duct stent after precut sphincterotomy or wire-guided method
- Have failed biliary cannulation
- Have severe active cardiopulmonary disease
- Are breastfeeding or pregnant
- Have an ampullary tumour
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Department of Gastroenterology, The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Not Yet Recruiting
2
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Actively Recruiting
Research Team
Q
Qiao Mei, MD
CONTACT
J
Junjun Bao, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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