Clinical Trial: Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: CO2 Cholangiography as an Alternative to Iodinated Contrast in Endoscopic Retrograde Cholangiopancreatography

Brief 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.

Detailed Summary:

It has been recommended that endoscopic retrograde cholangiopancreatography (ERCP) be performed using carbon dioxide (CO2) instead of room air as the infused "air" or gas for luminal insufflation for reasons of improved patient comfort and in case of procedural adverse events (as CO2 is more quickly absorbed by the body and as it can be exhaled via the lungs). Air cholangiograms are often incidentally visible on fluoroscopy (radiographically) during ERCP prior to injection of iodinated contrast into the biliary tree. Despite the information from an air cholangiogram being readily available in many instances, biliary endoscopists and radiologists who read the fluoroscopic images taken during ERCP do not usually comment or interpret the "air" or "CO2" cholangiograms. Consequently, very little data is available on the topic of "air" or "CO2" cholangiography. As a contrast medium for cholangiography, CO2 might be safer than iodinated contrast, which is the standard contrast medium used during ERCP, as iodinated contrast cannot be easily absorbed by the body and as it can be trapped proximal to obstructing biliary stones or strictures and lead to biliary tract infection.

This is a prospective cohort study that will enroll patients undergoing ERCP for suspected choledocholithiasis and/or biliary stricture(s). If they did not participate in this study, these patients would still require an ERCP with CO2 used as the endoscopically insufflated "air" medium. Enrolled patients will undergo an initial cholangiogram with CO2 (injected into the bile ducts) utilizing both conventional fluoroscopy and digital subtraction fluoroscopic imaging, followed by conventional cholangiography using iodinated contrast (injected into the bile ducts). Digital subtraction fluoroscopic imaging is a commercially available setting on certain flu
Sponsor: University of Virginia

Current Primary Outcome: Technical success of CO2 cholangiography vs. iodinated contrast [ Time Frame: Intraprocedural/immediate (during ERCP) ]

For choledocholithiasis: correct identification of the number and location of stones. For biliary strictures: correct identification of number and location of strictures.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Technical success of digital subtraction fluoroscopy vs. traditional fluoroscopy (while using CO2 as the contrast medium) [ Time Frame: Intraprocedural/immediate (during ERCP) ]
    For choledocholithiasis: correct identification of the number and location of stones. For biliary strictures: correct identification of number and location of strictures.
  • Radiation usage/exposure of CO2 cholangiography using conventional fluoroscopy or digital subtraction fluoroscopy vs. iodinated contrast [ Time Frame: Intraprocedural/immediate (during ERCP) ]
    Fluoroscopy/radiation usage/exposure will be measured for each imaging modality and then compared


Original Secondary Outcome: Same as current

Information By: University of Virginia

Dates:
Date Received: November 18, 2015
Date Started: February 2016
Date Completion: June 2017
Last Updated: October 24, 2016
Last Verified: October 2016