Timing of Indomethacin Administration for the Prevention of Post-ERCP Pancreatitis (PEP)
Phase 4
Completed
- Conditions
- Acute Pancreatitis
- Interventions
- Drug: Rectal indomethacin 100mg one time before or after ERCP
- Registration Number
- NCT02111707
- Lead Sponsor
- University of Alberta
- Brief Summary
To determine if the timing of administration of indomethacin affects the primary outcome of post-ERCP pancreatitis (PEP). Patients undergoing ERCP will be randomly assigned to receive pre or post-procedure rectal indomethacin to prevent the occurrence of PEP.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 534
Inclusion Criteria
- All patients referred for ERCP at the University of Alberta
- Age greater than 18 years
- Ability to provide written informed consent
Exclusion Criteria
- Acute pancreatitis
- Active peptic ulcer disease
- Rectal disease
- Aspirin-induced asthma
- Nonsteroidal anti-inflammatory drug (NSAIDs) induced hypersensitivity
- Pregnancy
- Breast feeding
- Creatinine clearance < 30 ml/min
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rectal Indomethacin pre-ERCP Rectal indomethacin 100mg one time before or after ERCP Patients will receive rectal indomethacin 100mg 30 minutes before procedure (ERCP). Rectal Indomethacin post-ERCP Rectal indomethacin 100mg one time before or after ERCP Patients will receive rectal indomethacin 100mg immediately after procedure (ERCP)
- Primary Outcome Measures
Name Time Method Rate of Post-ERCP pancreatitis 30 days
- Secondary Outcome Measures
Name Time Method Severity of Post-ERCP pancreatitis 30 days To evaluate the severity of post-ERCP pancreatitis between the 2 groups studied
Trial Locations
- Locations (1)
University of Alberta
🇨🇦Edmonton, Alberta, Canada
University of Alberta🇨🇦Edmonton, Alberta, Canada