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Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02611453
Enrollment
40
Registered
2015-11-20
Start date
2016-02-29
Completion date
2024-12-31
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Duct Carcinoma, Bile Duct Diseases, Choledocholithiasis

Keywords

choledocholithiasis, ERCP, cholangiography, biliary stricture, bile ducts, carbon dioxide

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 description

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 fluoroscopy units that optimizes resolution with air or CO2 used as a contrast medium. Findings on CO2 cholangiography will be compared to those obtained from pre-procedural abdominal imaging along with the cholangiogram done using iodinated contrast at the time of the ERCP procedures.

Interventions

OTHERAir contrast cholangiography using carbon dioxide gas

Carbon dioxide (CO2) will be injected into the biliary tree (which is already exposed to CO2 during routine ERCP) and images will be obtained by using fluoroscopy and digital subtraction imaging (a specific setting on certain fluoroscopy tables).

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Technical success of CO2 cholangiography vs. iodinated contrastIntraprocedural/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.

Secondary

MeasureTime frameDescription
Technical success of digital subtraction fluoroscopy vs. traditional fluoroscopy (while using CO2 as the contrast medium)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 contrastIntraprocedural/immediate (during ERCP)Fluoroscopy/radiation usage/exposure will be measured for each imaging modality and then compared

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026