Rectal Indomethacin to Prevent Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

Study Overview
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Brief Summary
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The purpose of this study is to assess whether peri-procedural administration of rectal indomethacin, compared to placebo, can reduce the incidence of post-ERCP pancreatitis.

Official Title
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Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Conditions
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Post-ERCP Acute Pancreatitis

Intervention / Treatment
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* Drug: Indomethacin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for an ERCP at Dartmouth-Hitchcock Age greater than 18 years old Ability to provide written informed consent Exclusion Criteria: Inability to provide written informed consent ERCP being performed for diagnosis and/or treatment of acute pancreatitis Current ongoing acute pancreatitis Previously documented allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Contra-indication to NSAID therapy (creatinine level >1.4 or active peptic ulcer disease), already taking NSAIDs (other than aspirin therapy for cardioprotection) Pregnant or nursing mothers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indomethacin<br>Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period | Drug: Indomethacin<br>* 100 mg Indomethacin PR x 1<br>|
| Placebo Comparator: Placebo<br>Placebo suppositories (#2) | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Developed Acute Pancreatitis | Number of patients who developed pancreatitis following ERCP based on Atlanta Classification | From randomization to 30 days after ERCP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Developed Severe Pancreatitis | Number of patients with severe acute pancreatitis based on the Atlanta Classification | From randomization to 30 days after ERCP | 
| Number of Patients Who Developed Moderately Severe Pancreatitis | Number of patients with moderately severe pancreatitis based on Atlanta Classification | From randomization to 30 days after ERCP | 
| Number of Patients Who Developed Mild Pancreatitis | Number of patient who developed mild acute pancreatitis based on the Atlanta Classification | From randomization to 30 days after ERCP | 
| Number of Patients Who Developed Gastrointestinal Bleeding | Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure | From randomization to 30 days after ERCP | 
| Number of Patient Deaths | Number of patients who died from any cause from the time of ERCP until 30 days post-procedure | From randomization to 30 days after ERCP | 
| Number of Patients With 30 Days Hospital Re-admission | Number of patients admitted to the hospital for any cause following ERCP | From randomization until 30 days after ERCP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post ERCP acute pancreatitis, Post Fine Needle Aspiration (FNA) acute pancreatitis, Indomethacin, Rectal Non Steroidal Anti-Inflammatory Drugs (NSAIDs)