Cholestasis
Conditions
Keywords
endoscopic retrograde cholangiopancreatography, carbon dioxide, randomized controlled clinical trial
Brief 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).
Interventions
OTHERCO2 insufflation
The bowel lumen will be insufflated with CO2 during the endoscopy (as compared to room air).
During the ERCP, room air will be insufflated (current standard clinical practice) as a placebo comparator.
Sponsors
Olympic Medical
National Institutes of Health (NIH)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal pain (VAS). | pre-procedure and up to 24 hours post-procedure. |
Secondary
| Measure | Time frame |
|---|---|
| The extent of CO2 retention. | Intra-procedure |
Countries
United States
Outcome results
None listed