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

October 24, 2017 updated by: University of Alberta
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

534

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2X8
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rectal Indomethacin pre-ERCP
Patients will receive rectal indomethacin 100mg 30 minutes before procedure (ERCP).
Drug: Rectal 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.
Other Names:
  • Indocid 100mg
Active Comparator: Rectal Indomethacin post-ERCP
Patients will receive rectal indomethacin 100mg immediately after procedure (ERCP)
Drug: Rectal 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.
Other Names:
  • Indocid 100mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of Post-ERCP pancreatitis
Time Frame: 30 days
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 9, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Actual)

October 25, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00041158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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