Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP (NCT02611453) | Clinical Trial Compass
UnknownNot Applicable
Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP
United States40 participantsStarted 2016-02
Plain-language summary
Carbon dioxide (CO2) gas is widely used for luminal insufflation during endoscopic retrograde cholangiopancreatography (ERCP) of the biliary tract. While frequently observed during routine ERCP, there are few data on the topic of "air" or "CO2" cholangiography. Our primary aim is to compare radiographic cholangiograms in patients with biliary tract disease (from stones or strictures) during ERCP obtained by using carbon dioxide as the contrast medium vs. conventional iodinated contrast.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients 18 years of age or older
* Patients with choledocholithiasis, benign biliary strictures, malignant biliary strictures
* Biliary pathology suggested or confirmed by imaging with abdominal ultrasonography, CT scan, MRI/MRCP scan, or endoscopic ultrasonography (EUS)
Exclusion Criteria:
* Pregnancy (self reported)
* Presence of cholangitis before ERCP
* Prior history of surgery on the stomach or duodenum that precludes conventional ERCP or prior biliary tree surgery (not including cholecystectomy)
* Failure to selectively cannulate the bile duct
* Life expectancy less than 30 days
* Prisoners
* Patients unable to give consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares carbon dioxide gas to the standard iodinated contrast dye used during ERCP — can you explain what that difference might mean for me, especially if I have any concerns about contrast dye reactions or kidney issues?
2Since this trial's recruitment status is listed as unknown, is it still actively enrolling patients, and if not, are there other similar studies I could be considered for?
3The trial is listed as Phase NA, which often means it's evaluating a technique or procedure rather than a drug — does that change what is already known about the safety of using CO2 during ERCP compared to the standard contrast approach?
4My condition involves the bile ducts, and this trial covers several diagnoses including stones and carcinoma — does my specific diagnosis make me a better or worse candidate for a study like this, or would standard ERCP with iodinated contrast be the more proven path for my situation?
5If I were to participate in this trial, how would it affect the actual ERCP procedure I'd be having — would there be extra steps, additional imaging, or a longer procedure time compared to just having the standard treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Technical success of CO2 cholangiography vs. iodinated contrast