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Trial record 14 of 2410 for:    CARBON DIOXIDE

Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP

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ClinicalTrials.gov Identifier: NCT02611453
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Y Wang, MD, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Choledocholithiasis Bile Duct Diseases Bile Duct Carcinoma Other: "Air" contrast cholangiography using carbon dioxide gas Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: CO2 Cholangiography as an Alternative to Iodinated Contrast in Endoscopic Retrograde Cholangiopancreatography
Study Start Date : February 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02611453


Contacts
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Contact: Andrew Y. Wang, MD 434-924-1653 ayw7d@virginia.edu
Contact: Daniel S. Strand, MD 434-243-2718 dss7a@virginia.edu

Locations
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United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Andrew Y Wang, MD    434-924-1653    ayw7d@virginia.edu   
Contact: Daniel S Strand, MD    434-243-2718    DSS7A@virginia.edu   
Principal Investigator: Andrew Y Wang, MD         
Sub-Investigator: Michael B McCabe, MD         
Sub-Investigator: Daniel S Strand, MD         
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Andrew Y. Wang, MD University of Virginia
Study Director: Michael B. McCabe, MD University of Virginia

Publications:
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Responsible Party: Andrew Y Wang, MD, Associate Professor of Medicine, University of Virginia
ClinicalTrials.gov Identifier: NCT02611453     History of Changes
Other Study ID Numbers: 18285
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Andrew Y Wang, MD, University of Virginia:
choledocholithiasis
ERCP
cholangiography
biliary stricture
bile ducts
carbon dioxide

Additional relevant MeSH terms:
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Choledocholithiasis
Carcinoma, Ductal
Bile Duct Diseases
Common Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholelithiasis
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Ductal, Lobular, and Medullary