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

University of North Carolina, Chapel Hill74 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Cholestasis

Interventions

CO2 insufflationOTHER

The bowel lumen will be insufflated with CO2 during the endoscopy (as compared to room air).

Room air insufflationOTHER

During the ERCP, room air will be insufflated (current standard clinical practice) as a placebo comparator.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Abdominal pain (VAS).

Time frame: pre-procedure and up to 24 hours post-procedure.

Secondary Outcomes

The extent of CO2 retention.

Time frame: Intra-procedure

Data from ClinicalTrials.gov

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