Oral indomethacin for the prevention of post-ERCP pancreatitis: A Randomized Controlled Trial
Phase 4
Recruiting
- Conditions
- post-ERCP complications (including bleeding,biliary infection,perforation and any adverse outcomes requiring hospital admission or prolonged hospital stay for further management) were monitored. PatPost-ERCP pancreatitis
- Registration Number
- TCTR20190218006
- Lead Sponsor
- The Gastroenterological Association of Thailand
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 350
Inclusion Criteria
Patient (aged 18-85 years) with naïve papilla planned for diagnostic or therapeutic ERCP were eligible for enrollment in the study
Exclusion Criteria
contraindication to ERCP, allergy to NSAIDs, contraindication to NSAIDs (including gastrointestinal hemorrhage within 4 weeks or renal dysfunction with serum creatinine > 1.4 mg/dl), previous biliary sphincterotomy, active pancreatitis, previous post-ERCP pancreatitis, active cardiovascular or cerebrovascular disease, unwilling or inability to provide consent and pregnant or breastfeeding women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The incidence of post-ERCP pancreatitis 30 days Clinical follow-up and blood test
- Secondary Outcome Measures
Name Time Method Adverse events of oral indomethacin administration 1 year Number of events