A Randomized Controlled Trial (RCT) of Carbon Dioxide Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
A Randomized, Controlled, Double-blind Trial of CO2 Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography
1 other identifier
interventional
74
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2008
CompletedFirst Posted
Study publicly available on registry
May 28, 2008
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedJanuary 24, 2013
April 1, 2011
7 months
May 23, 2008
January 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Abdominal pain (VAS).
pre-procedure and up to 24 hours post-procedure.
Secondary Outcomes (1)
The extent of CO2 retention.
Intra-procedure
Study Arms (2)
I
EXPERIMENTALII
PLACEBO COMPARATORRoom air will be used for insufflation as the placebo comparator arm.
Interventions
The bowel lumen will be insufflated with CO2 during the endoscopy (as compared to room air).
During the ERCP, room air will be insufflated (current standard clinical practice) as a placebo comparator.
Eligibility Criteria
You may qualify if:
- age \>= 18 years
- referred for ERCP for any indication at UNC Hospitals
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of North Carolina, Chapel Hilllead
- Olympic Medicalcollaborator
- National Institutes of Health (NIH)collaborator
Study Sites (1)
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Related Publications (1)
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.
PMID: 20493485DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evan S. Dellon, MD MPH
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 23, 2008
First Posted
May 28, 2008
Study Start
June 1, 2008
Primary Completion
January 1, 2009
Study Completion
February 1, 2009
Last Updated
January 24, 2013
Record last verified: 2011-04