Timing of Indomethacin Administration for the Prevention of Post-ERCP Pancreatitis (PEP)

University of Alberta534 enrolled

Overview

To determine if the timing of administration of indomethacin affects the primary outcome of post-ERCP pancreatitis (PEP). Patients undergoing ERCP will be randomly assigned to receive pre or post-procedure rectal indomethacin to prevent the occurrence of PEP.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

534

Conditions

Acute Pancreatitis

Interventions

Rectal indomethacin 100mg one time before or after ERCPDRUG

Patients will receive rectal indomethacin suppository 30 minutes before or immediately after ERCP for prevention of post-procedure pancreatitis. Patients will be randomized to the timing of administration.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All patients referred for ERCP at the University of Alberta * Age greater than 18 years * Ability to provide written informed consent Exclusion Criteria: * Acute pancreatitis * Active peptic ulcer disease * Rectal disease * Aspirin-induced asthma * Nonsteroidal anti-inflammatory drug (NSAIDs) induced hypersensitivity * Pregnancy * Breast feeding * Creatinine clearance \< 30 ml/min

Locations (1)

University of Alberta

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

Rate of Post-ERCP pancreatitis

Time frame: 30 days

Secondary Outcomes

Severity of Post-ERCP pancreatitis

To evaluate the severity of post-ERCP pancreatitis between the 2 groups studied

Time frame: 30 days

Data from ClinicalTrials.gov

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