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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02111707

Enrollment

534

Registered

2014-04-11

Start date

2014-04-30

Completion date

2017-09-30

Last updated

2017-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis

Brief summary

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.

Interventions

DRUGRectal indomethacin 100mg one time before or after ERCP

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of Post-ERCP pancreatitis	30 days

Secondary

Measure	Time frame	Description
Severity of Post-ERCP pancreatitis	30 days	To evaluate the severity of post-ERCP pancreatitis between the 2 groups studied

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026