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

University of North Carolina (UNC)

Status: Completed

Conditions: Cholestasis

Treatments: Other: Room air insufflation; Other: CO2 insufflation

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00685386

07-1404

Details and patient eligibility

About

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).

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

74 participants in 2 patient groups, including a placebo group

I

Experimental group

Treatment:

Other: CO2 insufflation

II

Placebo Comparator group

Description:

Room air will be used for insufflation as the placebo comparator arm.

Treatment:

Other: Room air insufflation