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Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP

Primary Purpose

Choledocholithiasis, Bile Duct Diseases, Bile Duct Carcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
"Air" contrast cholangiography using carbon dioxide gas
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Choledocholithiasis focused on measuring choledocholithiasis, ERCP, cholangiography, biliary stricture, bile ducts, carbon dioxide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Virginia Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Technical success of CO2 cholangiography vs. iodinated contrast
For choledocholithiasis: correct identification of the number and location of stones. For biliary strictures: correct identification of number and location of strictures.

Secondary Outcome Measures

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

Full Information

First Posted
November 18, 2015
Last Updated
June 5, 2022
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT02611453
Brief Title
Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP
Official Title
CO2 Cholangiography as an Alternative to Iodinated Contrast in Endoscopic Retrograde Cholangiopancreatography
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2016 (undefined)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choledocholithiasis, Bile Duct Diseases, Bile Duct Carcinoma
Keywords
choledocholithiasis, ERCP, cholangiography, biliary stricture, bile ducts, carbon dioxide

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
"Air" contrast cholangiography using carbon dioxide gas
Intervention Description
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).
Primary Outcome Measure Information:
Title
Technical success of CO2 cholangiography vs. iodinated contrast
Description
For choledocholithiasis: correct identification of the number and location of stones. For biliary strictures: correct identification of number and location of strictures.
Time Frame
Intraprocedural/immediate (during ERCP)
Secondary Outcome Measure Information:
Title
Technical success of digital subtraction fluoroscopy vs. traditional fluoroscopy (while using CO2 as the contrast medium)
Description
For choledocholithiasis: correct identification of the number and location of stones. For biliary strictures: correct identification of number and location of strictures.
Time Frame
Intraprocedural/immediate (during ERCP)
Title
Radiation usage/exposure of CO2 cholangiography using conventional fluoroscopy or digital subtraction fluoroscopy vs. iodinated contrast
Description
Fluoroscopy/radiation usage/exposure will be measured for each imaging modality and then compared
Time Frame
Intraprocedural/immediate (during ERCP)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Y. Wang, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23621432
Citation
Zhang R, Zhao L, Liu Z, Wang B, Hui N, Wang X, Huang R, Luo H, Fan D, Pan Y, Guo X. Effect of CO2 cholangiography on post-ERCP cholangitis in patients with unresectable malignant hilar obstruction - a prospective, randomized controlled study. Scand J Gastroenterol. 2013 Jun;48(6):758-63. doi: 10.3109/00365521.2013.779745. Epub 2013 Apr 29.
Results Reference
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PubMed Identifier
19707784
Citation
Pisello F, Geraci G, Modica G, Sciume C. Cholangitis prevention in endoscopic Klatskin tumor palliation: air cholangiography technique. Langenbecks Arch Surg. 2009 Nov;394(6):1109-14. doi: 10.1007/s00423-009-0548-y. Epub 2009 Aug 26.
Results Reference
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Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP

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