NCT00820612

Rectal Indomethacin in the Prevention of Post-endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High Risk Patients

A Prospective, Randomized, Controlled Trial of Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis in High Risk Patients.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 602 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-ERCP Pancreatitis

Interventions

Type	Name	Description
DRUG	Indomethacin	100 mg PR once at the time of ERCP
OTHER	Placebo suppositories	2 placebo suppositories at the time of ERCP

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2009-01-12
• Last updated: 2013-02-28
• Results posted: 2013-02-12

Locations

4 sites across 1 country: United States