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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alberta

Edmonton, Alberta, T6G2X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rectal indomethacin 100mg one time before or after ERCP

Drug

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.

Other names: Indocid 100mg

Primary outcomes

Rate of Post-ERCP pancreatitis

Time frame: 30 days

Secondary outcomes

Severity of Post-ERCP pancreatitis

Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2017
First posted: Apr 11, 2014
Registry last updated: Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed