Conditions: Post-ERCP Pancreatitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 602
Healthy volunteers: no

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.

Arms:
arm 1: Indomethacin suppository arm 2: Placebo suppository

Interventions: intervention 1: Indomethacin intervention 2: Placebo suppositories
Intervention descriptions: intervention 1: 100 mg PR once at the time of ERCP intervention 2: 2 placebo suppositories at the time of ERCP

Protocol document: