MedTrace Logo

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

NCT00727740 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2017-01-18

Study results available
· View outcomes & findings →

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 risk of pancreatitis after Endoscopic Retrograde Cholangio-Pancreatography (ERCP.) The hypothesis is that indomethacin decreases the incidence and severity of post-ERCP pancreatitis. Patients who are scheduled to undergo a ERCP will be enrolled. Following ERCP, patients will be randomized to receive a dose of indomethacin or placebo (an inactive substance) instilled into the duodenum via the biopsy channel of the duodenoscope. All patients will be observed for 4 hours following ERCP which is part of routine clinical practice. Patients with minimal pain will be discharged after this 4 hour observation period. All patients will have baseline serum amylase levels which are repeated 2 to 4 hours after the ERCP has been completed. Patients who have significant abdominal pain will be hospitalized and evaluated for pancreatitis. Patients discharged to home will be contacted by telephone the following day to ask them if they have had any complications of ERCP.

Conditions

Interventions

DRUG

Indomethacin

Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.

DRUG

Placebo suspension

A placebo suspension which is made by the Investigational Drug Service (IDS) by adding the appropriate dye coloring to normal saline so that the appearance is identical to the indomethacin suspension. The placebo solution is also instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the placebo suspension, the catheter is flushed with 5 cc of normal saline.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Priya Jamidar, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2011-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00727740 on ClinicalTrials.gov