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

Not Applicable

Completed

• Conditions: Cholestasis
• Interventions: Other: CO2 insufflation; Other: Room air insufflation

• 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

Study Timeline

• Study First Submitted: 2008-05-23
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Study Start: 2008-06
• Primary Completion: 2009-01
• Study Completion: 2009-02
• Status Verified: 2011-04
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	CO2 insufflation	-
II	Room air insufflation	Room air will be used for insufflation as the placebo comparator arm.

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