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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Post-ERCP Pancreatitis

Intervention / Treatment
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* Drug: Indomethacin
* Other: Placebo suppositories


Participation Criteria
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Eligibility Criteria
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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 History of recurrent pancreatitis (at least 2 episodes) ≥3 pancreatic injections, with at least one injection to tail Pancreatic acinarization Pancreatic brush cytology 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 Pancreatic head malignancy Procedure performed on major papilla/ventral panc duct in pt with pancreas divisum (no manipulation of minor papilla) ERCP for biliary stent removal or exchange without anticipated pancreatogram Subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram Anticipated inability to follow protocol Endoscopist discretion: low risk (<10%) of post-ERCP pancreatitis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Indomethacin suppository | Drug: Indomethacin<br>* 100 mg PR once at the time of ERCP<br>|
| Placebo Comparator: 2<br>Placebo suppository | Other: Placebo suppositories<br>* 2 placebo suppositories at the time of ERCP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-ERCP Pancreatitis | 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. | 5 days |