Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?
Not Applicable
Recruiting
- Conditions
- Endoscopic Retrograde Cholangiopancreatography
- Interventions
- Device: Biliary cannulation
- Registration Number
- NCT04408482
- Lead Sponsor
- Helsinki University Central Hospital
- Brief Summary
The purpose of the study is to compare the risk of PEP after pancreatic sphincterotomy performed for difficult cannulation in a group of patients with and in a group of patients without placement of a prophylactic pancreatic stent. The definition of difficult cannulation is defined according to the literature.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 268
Inclusion Criteria
- Consecutive patients with naïve papilla presenting to ERCP with indication of common bile duct (CBD) cannulation will be considered to the study.
Exclusion Criteria
- Exclusion criteria are age below 18 years, acute pancreatitis and no consent to the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pancreatic sphincterotomy Biliary cannulation Pancreatic sphincterotomy performed in difficult cannulation Pancreatic sphincterotomy + pancreatic stent Biliary cannulation Pancreatic sphincterotomy performed in difficult cannulation + pancreatic stent placement
- Primary Outcome Measures
Name Time Method Post-ERCP pancreatitis rate 30 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Helsinki Univeristy Hospital
🇫🇮Helsinki, Finland