Status:

COMPLETED

A Double-blind Study to Determine if Intraduodenal Indomethacin Can Decrease the Incidence of Post-ERCP Pancreatitis

Lead Sponsor:

Yale University

Conditions:

Pancreatitis

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The purpose of this research study is to determine if indomethacin, an anti-inflammatory medication in a class of medications known at NSAIDs (non-steroidal anti-inflammatory drugs) can reduce the ris...

Detailed Description

Post-ERCP pancreatitis is likely due to the patient's inflammatory response to duct instrumentation during the procedure and severity is based on the magnitude of this response. Phospholipase A2 (PLA2...

Eligibility Criteria

Inclusion

  • Patients undergoing ERCP as part of their clinical care.

Exclusion

  • Pancreatitis within 60 days of ERCP
  • Age less than 18 years
  • Pregnant patients
  • Patients who have received NSAIDs within the past 7 days
  • Patients with a previous allergy to NSAIDs
  • Patients who were previously enrolled in the study
  • Patients with a history of peptic ulcers, gastrointestinal bleeding, on anticoagulants and/or with a bleeding diathesis.

Key Trial Info

Start Date :

August 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2012

Estimated Enrollment :

117 Patients enrolled

Trial Details

Trial ID

NCT00727740

Start Date

August 1 2005

End Date

August 1 2012

Last Update

January 18 2017

Active Locations (1)

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1

Yale New Haven Hospital

New Haven, Connecticut, United States, 06520