A Randomized Controlled Trial (RCT) of Carbon Dioxide Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00685386|
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : January 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cholestasis||Other: CO2 insufflation Other: Room air insufflation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized, Controlled, Double-blind Trial of CO2 Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||February 2009|
Other: CO2 insufflation
The bowel lumen will be insufflated with CO2 during the endoscopy (as compared to room air).
Other Name: Olympus XUCR manufacured by Olympus Medical.
Placebo Comparator: II
Room air will be used for insufflation as the placebo comparator arm.
Other: Room air insufflation
During the ERCP, room air will be insufflated (current standard clinical practice) as a placebo comparator.
- Abdominal pain (VAS). [ Time Frame: pre-procedure and up to 24 hours post-procedure. ]
- The extent of CO2 retention. [ Time Frame: Intra-procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685386
|United States, North Carolina|
|University of North Carolina-Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Evan S. Dellon, MD MPH||University of North Carolina, Chapel Hill|