Back to resultsA Randomized Controlled Trial (RCT) of Carbon Dioxide Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Primary Purpose
Cholestasis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CO2 insufflation
Room air insufflation
Sponsored by
About this trial
This is an interventional supportive care trial for Cholestasis focused on measuring endoscopic retrograde cholangiopancreatography, carbon dioxide, randomized controlled clinical trial
Eligibility Criteria
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
Sites / Locations
- University of North Carolina-Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
I
II
Arm Description
Room air will be used for insufflation as the placebo comparator arm.
Outcomes
Primary Outcome Measures
Abdominal pain (VAS).
Secondary Outcome Measures
The extent of CO2 retention.
Full Information
NCT ID
NCT00685386
First Posted
May 23, 2008
Last Updated
January 22, 2013
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Olympic Medical, National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00685386
Brief Title
A Randomized Controlled Trial (RCT) of Carbon Dioxide Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Official Title
A Randomized, Controlled, Double-blind Trial of CO2 Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Olympic Medical, National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholestasis
Keywords
endoscopic retrograde cholangiopancreatography, carbon dioxide, randomized controlled clinical trial
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Experimental
Arm Title
II
Arm Type
Placebo Comparator
Arm Description
Room air will be used for insufflation as the placebo comparator arm.
Intervention Type
Other
Intervention Name(s)
CO2 insufflation
Other Intervention Name(s)
Olympus XUCR manufacured by Olympus Medical.
Intervention Description
The bowel lumen will be insufflated with CO2 during the endoscopy (as compared to room air).
Intervention Type
Other
Intervention Name(s)
Room air insufflation
Intervention Description
During the ERCP, room air will be insufflated (current standard clinical practice) as a placebo comparator.
Primary Outcome Measure Information:
Title
Abdominal pain (VAS).
Time Frame
pre-procedure and up to 24 hours post-procedure.
Secondary Outcome Measure Information:
Title
The extent of CO2 retention.
Time Frame
Intra-procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan S. Dellon, MD MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina-Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20493485
Citation
Dellon ES, Velayudham A, Clarke BW, Isaacs KL, Gangarosa LM, Galanko JA, Grimm IS. A randomized, controlled, double-blind trial of air insufflation versus carbon dioxide insufflation during ERCP. Gastrointest Endosc. 2010 Jul;72(1):68-77. doi: 10.1016/j.gie.2010.01.041. Epub 2010 May 20.
Results Reference
derived
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A Randomized Controlled Trial (RCT) of Carbon Dioxide Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
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