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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014