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

Cholestasis Clinical Trial

Official title:

A Randomized, Controlled, Double-blind Trial of CO2 Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685386
• Other study ID #: 07-1404
• Status: Completed
• Phase: N/A
• First received: May 23, 2008
• Last updated: January 22, 2013
• Start date: June 2008
• Est. completion date: February 2009

Study information

• Verified date: April 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cholestasis

Intervention

Other:
• CO2 insufflation
The bowel lumen will be insufflated with CO2 during the endoscopy (as compared to room air).
• Room air insufflation
During the ERCP, room air will be insufflated (current standard clinical practice) as a placebo comparator.

Locations

Country	Name	City	State
United States	University of North Carolina-Chapel Hill	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institutes of Health (NIH), Olympic Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal pain (VAS).		pre-procedure and up to 24 hours post-procedure.	No
Secondary	The extent of CO2 retention.		Intra-procedure	Yes