NCT00685386CompletedNot Applicable
A Randomized, Controlled, Double-blind Trial of CO2 Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography
University of North Carolina, Chapel Hill1 site in 1 country74 target enrollmentStarted: June 1, 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- Abdominal pain (VAS).
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
I
Experimental
Intervention: CO2 insufflation (Other)
II
Placebo Comparator
Room air will be used for insufflation as the placebo comparator arm.
Intervention: Room air insufflation (Other)
Outcomes
Primary Outcomes
Abdominal pain (VAS).
Time Frame: pre-procedure and up to 24 hours post-procedure.
Secondary Outcomes
- The extent of CO2 retention.(Intra-procedure)
Investigators
Study Sites (1)
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