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

This study has been completed.
Sponsor:
Collaborators:
Olympic Medical
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00685386
First received: May 23, 2008
Last updated: January 22, 2013
Last verified: April 2011
  Purpose

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).


Condition Intervention
Cholestasis
Other: CO2 insufflation
Other: Room air insufflation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized, Controlled, Double-blind Trial of CO2 Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Abdominal pain (VAS). [ Time Frame: pre-procedure and up to 24 hours post-procedure. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The extent of CO2 retention. [ Time Frame: Intra-procedure ] [ Designated as safety issue: Yes ]

Enrollment: 74
Study Start Date: June 2008
Study Completion Date: February 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685386

Locations
United States, North Carolina
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Olympic Medical
Investigators
Principal Investigator: Evan S. Dellon, MD MPH University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Evan S. Dellon, MD, University of North Carolina-Chapel Hill
ClinicalTrials.gov Identifier: NCT00685386     History of Changes
Other Study ID Numbers: 07-1404
Study First Received: May 23, 2008
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
endoscopic retrograde cholangiopancreatography
carbon dioxide
randomized controlled clinical trial

Additional relevant MeSH terms:
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014