A Randomized Controlled Trial (RCT) of Carbon Dioxide Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Not Applicable
Completed
- Conditions
- Cholestasis
- Registration Number
- NCT00685386
- Lead Sponsor
- University of North Carolina, Chapel Hill
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
Inclusion Criteria
- age >= 18 years
- referred for ERCP for any indication at UNC Hospitals
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Abdominal pain (VAS). pre-procedure and up to 24 hours post-procedure.
- Secondary Outcome Measures
Name Time Method The extent of CO2 retention. Intra-procedure
Trial Locations
- Locations (1)
University of North Carolina-Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
University of North Carolina-Chapel Hill🇺🇸Chapel Hill, North Carolina, United States