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A Randomized Controlled Trial (RCT) of Carbon Dioxide Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP)

NCT00685386 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2013-01-24

No results posted yet for this study

Summary

The purpose of this study it to conduct a randomized, controlled, double-blinded trial of carbon dioxide (CO2) versus air insufflation during endoscopic retrograde cholangiopancreatography (ERCP).

Conditions

  • Cholestasis

Interventions

OTHER

CO2 insufflation

The bowel lumen will be insufflated with CO2 during the endoscopy (as compared to room air).

OTHER

Room air insufflation

During the ERCP, room air will be insufflated (current standard clinical practice) as a placebo comparator.

Sponsors & Collaborators

  • Olympic Medical

    collaborator INDUSTRY

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Evan S. Dellon, MD MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-01-31
Completion
2009-02-28

Countries

  • United States

Study Locations

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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 NCT00685386 on ClinicalTrials.gov