Status:

COMPLETED

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

Lead Sponsor:

University of North Carolina, Chapel Hill

Collaborating Sponsors:

Olympic Medical

National Institutes of Health (NIH)

Conditions:

Cholestasis

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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).

Eligibility Criteria

Inclusion

  • age \>= 18 years
  • referred for ERCP for any indication at UNC Hospitals

Exclusion

  • age \< 18 years
  • COPD requiring oxygen or with known CO2 retention
  • any medical condition with known CO2 retention
  • medical instability making the procedure unsafe
  • absolute requirement for same-day second endoscopy
  • ERCP performed in the OR or under GA
  • inability to read or understand English
  • use of chronic opiates for pain
  • pregnant women

Key Trial Info

Start Date :

June 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2009

Estimated Enrollment :

74 Patients enrolled

Trial Details

Trial ID

NCT00685386

Start Date

June 1 2008

End Date

February 1 2009

Last Update

January 24 2013

Active Locations (1)

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University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, United States, 27599