Randomized Trial of Rectal Indomethacin and Papillary Spray of Epinephrine Versus Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

NCT02116309 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 948

Last updated 2017-11-01

Study results available
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Summary

This research is being done to see if using a combination of rectal indomethacin and epinephrine spray during endoscopy, can prevent pancreatitis that may occur after ERCP (a type of gastrointestinal endoscopy).

Conditions

  • Post-ERCP Acute Pancreatitis

Interventions

DRUG

Rectal Indomethacin

Sponsors & Collaborators

  • American Society for Gastrointestinal Endoscopy

    collaborator OTHER
  • Asian Institute of Gastroenterology, India

    collaborator OTHER
  • Post Graduate Institute of Medical Education and Research, Chandigarh

    collaborator OTHER
  • Apollo Gleneagles Hospitals, Kolkata

    collaborator OTHER
  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Vikesh K Singh, M.D., M.Sc. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-12-02
Completion
2016-12-02

Countries

  • United States
  • India

Study Locations

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Entities

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 NCT02116309 on ClinicalTrials.gov