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

Phase 3

Terminated

• Conditions: Post-ERCP Acute Pancreatitis
• Interventions: Drug: Placebo; Drug: Indomethacin

• Registration Number: NCT01774604
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-21
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-24
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2016-07-29
• Results First Submitted QC: 2016-07-29
• Status Verified: 2016-09
• Results First Posted: 2016-09-20
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 449

Inclusion Criteria

1. Scheduled for an ERCP at Dartmouth-Hitchcock
2. Age greater than 18 years old
3. Ability to provide written informed consent

Exclusion Criteria

1. Inability to provide written informed consent
2. ERCP being performed for diagnosis and/or treatment of acute pancreatitis
3. Current ongoing acute pancreatitis
4. Previously documented allergy to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
5. Contra-indication to NSAID therapy (creatinine level >1.4 or active peptic ulcer disease), already taking NSAIDs (other than aspirin therapy for cardioprotection)
6. Pregnant or nursing mothers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo suppositories (#2)
Indomethacin	Indomethacin	Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Developed Acute Pancreatitis	From randomization to 30 days after ERCP	Number of patients who developed pancreatitis following ERCP based on Atlanta Classification

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States