A Prospective, Randomized, Controlled Trial of Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients.
Overview
- Phase
- Phase 4
- Intervention
- Indomethacin
- Conditions
- Post-ERCP Pancreatitis
- Sponsor
- University of Michigan
- Enrollment
- 602
- Locations
- 4
- Primary Endpoint
- Post-ERCP Pancreatitis
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
Pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct.
Preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally, can reduce the risk of pancreatitis after ERCP. This study is intended to definitively determine whether rectally administered indomethacin (a non-steroidal antiinflammatory drug)is effective at preventing pancreatitis after ERCP.
Detailed Description
This study is a multi-center, randomized, placebo-controlled, double-blinded clinical trial of rectal indomethacin in the prevention of post-ERCP pancreatitis in high risk patients.
Investigators
Badih Joseph Elmunzer
Assistant Professor, Gastroenterology
University of Michigan
Eligibility Criteria
Inclusion Criteria
- •Included patients are those undergoing ERCP and have one of the following:
- •Clinical suspicion of sphincter of Oddi dysfunction
- •History of post-ERCP pancreatitis (at least one episode)
- •Pancreatic sphincterotomy
- •Pre-cut (access) sphincterotomy
- •\> 8 cannulation attempts
- •Pneumatic dilation of intact biliary sphincter
- •Ampullectomy
- •or at least 2 of the following:
- •Age \< 50 years old \& female gender
Exclusion Criteria
- •Unwillingness or inability to consent for the study
- •Age \< 18 years
- •Intrauterine pregnancy
- •Breast feeding mother
- •Standard contraindications to ERCP
- •Allergy to Aspirin or NSAIDs
- •Renal failure (Cr \> 1.4)
- •Active or recent (within 4 weeks) gastrointestinal hemorrhage
- •Acute pancreatitis (lipase peak) within 72 hours
- •Known chronic calcific pancreatitis
Arms & Interventions
1
Indomethacin suppository
Intervention: Indomethacin
2
Placebo suppository
Intervention: Placebo suppositories
Outcomes
Primary Outcomes
Post-ERCP Pancreatitis
Time Frame: 5 days
Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, pancreatic enzyme elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization of at least two nights.