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

Dartmouth Health

Status and phase: Terminated; Phase 3

Conditions: Post-ERCP Acute Pancreatitis

Treatments: Drug: Indomethacin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01774604

CPHS#23749

Details and patient eligibility

About

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.

Enrollment: 449 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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449 participants in 2 patient groups, including a placebo group

Indomethacin

Experimental group

Description:

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

Treatment:

Drug: Indomethacin

Placebo

Placebo Comparator group

Description:

Placebo suppositories (#2)

Treatment:

Drug: Placebo