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

September 28, 2016 updated by: Dartmouth-Hitchcock Medical Center

Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

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.

Study Overview

Status

Terminated

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

449

Phase

  • Phase 3

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

    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center

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:

  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

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Indomethacin
Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period
100 mg Indomethacin PR x 1
Placebo Comparator: Placebo
Placebo suppositories (#2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Who Developed Acute Pancreatitis
Time Frame: From randomization to 30 days after ERCP
Number of patients who developed pancreatitis following ERCP based on Atlanta Classification
From randomization to 30 days after ERCP

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Who Developed Severe Pancreatitis
Time Frame: From randomization to 30 days after ERCP
Number of patients with severe acute pancreatitis based on the Atlanta Classification
From randomization to 30 days after ERCP
Number of Patients Who Developed Moderately Severe Pancreatitis
Time Frame: From randomization to 30 days after ERCP
Number of patients with moderately severe pancreatitis based on Atlanta Classification
From randomization to 30 days after ERCP
Number of Patients Who Developed Mild Pancreatitis
Time Frame: From randomization to 30 days after ERCP
Number of patient who developed mild acute pancreatitis based on the Atlanta Classification
From randomization to 30 days after ERCP
Number of Patients Who Developed Gastrointestinal Bleeding
Time Frame: From randomization to 30 days after ERCP
Number of patients who developed any type of gastrointestinal bleeding from time of ERCP to 30 days post procedure
From randomization to 30 days after ERCP
Number of Patient Deaths
Time Frame: From randomization to 30 days after ERCP
Number of patients who died from any cause from the time of ERCP until 30 days post-procedure
From randomization to 30 days after ERCP
Number of Patients With 30 Days Hospital Re-admission
Time Frame: From randomization until 30 days after ERCP
Number of patients admitted to the hospital for any cause following ERCP
From randomization until 30 days after ERCP

Collaborators and Investigators

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

Investigators

  • Principal Investigator: John M Levenick, MD, Dartmouth-Hitchcock Medical Center

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.

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

January 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 21, 2013

First Submitted That Met QC Criteria

January 23, 2013

First Posted (Estimate)

January 24, 2013

Study Record Updates

Last Update Posted (Estimate)

November 4, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

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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