Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Dartmouth-Hitchcock Medical Center1 site in 1 country449 target enrollmentJanuary 2013

ConditionsPost-ERCP Acute Pancreatitis

InterventionsIndomethacin Placebo

DrugsIndomethacin Placebo

Overview

Phase: Phase 3
Intervention: Indomethacin
Conditions: Post-ERCP Acute Pancreatitis
Sponsor: Dartmouth-Hitchcock Medical Center
Enrollment: 449
Locations: 1
Primary Endpoint: Number of Patients Who Developed Acute Pancreatitis
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

December 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Dartmouth-Hitchcock Medical Center

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Indomethacin

Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period

Intervention: Indomethacin

Placebo

Placebo suppositories (#2)

Intervention: Placebo

Outcomes

Primary Outcomes

Number of Patients Who Developed Acute Pancreatitis

Time Frame: From randomization to 30 days after ERCP

Number of patients who developed pancreatitis following ERCP based on Atlanta Classification

Secondary Outcomes

Number of Patients Who Developed Moderately Severe Pancreatitis(From randomization to 30 days after ERCP)
Number of Patients Who Developed Severe Pancreatitis(From randomization to 30 days after ERCP)
Number of Patients With 30 Days Hospital Re-admission(From randomization until 30 days after ERCP)
Number of Patients Who Developed Mild Pancreatitis(From randomization to 30 days after ERCP)
Number of Patients Who Developed Gastrointestinal Bleeding(From randomization to 30 days after ERCP)
Number of Patient Deaths(From randomization to 30 days after ERCP)