Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP

January 1, 2024 updated by: Andrew Y Wang, MD, University of Virginia

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
All patients will undergo endoscopic retrograde cholangiopancreatography (ERCP) that is indicated for suspected or confirmed choledocholithiasis or biliary strictures. "Air" contrast cholangiography using carbon dioxide gas will be performed with standard fluoroscopy and digital subtraction fluoroscopic image capture followed by routine cholangiography using iodinated contrast and standard fluoroscopy. Carbon dioxide (CO2) is routinely used in ERCP procedures and would flow into the biliary tree of patients at the time of ERCP, irrespective of this study's interventions. Digital subtraction image capture is a commercially available setting on certain fluoroscopy units that optimizes resolution with air or CO2 used as a contrast medium.
Other: "Air" 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraprocedural/immediate (during ERCP)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Intraprocedural/immediate (during ERCP)
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
Intraprocedural/immediate (during ERCP)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

  • Principal Investigator: Andrew Y. Wang, MD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

November 18, 2015

First Submitted That Met QC Criteria

November 18, 2015

First Posted (Estimated)

November 20, 2015

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 1, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18285

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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