MedTrace Logo

Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis

NCT01912716 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1037

Last updated 2019-07-05

Study results available
· View outcomes & findings →

Summary

It is now established that indomethacin, a non-steroidal anti-inflammatory drug, at a dose of 100 mg, is effective in reducing the frequency and severity of pancreatitis (inflammation of the pancreas) after endoscopic retrograde cholangiopancreatography (ERCP) in high risk patients. However, the optimal dose required is not known. The purpose of this study is to determine whether a dose of 200 mg, administered as rectal suppositories, is more effective than the standard dose of 100 mg. An ERCP procedure is a scope procedure where a lighted tube with a camera is passed down the patient's throat and allows for evaluation of the bile duct and/or pancreatic duct. The most common side effect of this procedure is post-ERCP pancreatitis, or swelling of the pancreas. Some patients are at higher risk for this complication than others. Our hypothesis is to compare the efficacy of these two dose regimens (100 mg vs 200 mg) of prophylactic rectally-administered indomethacin on the frequency and severity of post-ERCP pancreatitis in high-risk patients.

Conditions

  • Post-ERCP Pancreatitis

Interventions

DRUG

high dose indomethacin

patients randomized to this intervention receive 200mg indomethacin

DRUG

standard dose indomethacin

patients randomized to this intervention receive 100mg indomethacin

Sponsors & Collaborators

  • American College of Gastroenterology

    collaborator OTHER

  • University of Michigan

    collaborator OTHER

  • University of Texas

    collaborator OTHER

  • Wake Forest University Health Sciences

    collaborator OTHER

  • Medical University of South Carolina

    collaborator OTHER

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Evan L Fogel, MD, MSc · Indiana University Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2018-04-30
Completion
2018-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01912716 on ClinicalTrials.gov