CholedocholithiasisNCT02611453
Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP
A study testing "Air" contrast cholangiography using carbon dioxide gas in people with Choledocholithiasis and Bile Duct Diseases, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choledocholithiasis, Bile Duct Diseases, Bile Duct Carcinoma
- What is being tested?
- "Air" contrast cholangiography using carbon dioxide gas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
Official title: 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.
Read the 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.
- Conditions
- Choledocholithiasis, Bile Duct Diseases, Bile Duct Carcinoma
- Being tested
- "Air" contrast cholangiography using carbon dioxide gas
- Keywords
- choledocholithiasis, ERCP, cholangiography, biliary stricture, bile ducts, carbon dioxide
- Medical subject headings
- Choledocholithiasis, Bile Duct Diseases, Bile Duct Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Air" contrast cholangiography using carbon dioxide gasOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | 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. Receives: Other: "Air" contrast cholangiography using carbon dioxide gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraprocedural/immediate (during ERCP)
Secondary outcomes (2)
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.
Measured: Intraprocedural/immediate (during ERCP)
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
Measured: Intraprocedural/immediate (during ERCP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CholedocholithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Y Wang, MD, University of Virginia
- Investigators
- Andrew Y. Wang, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611453
- Sponsor's protocol ID
- 18285
- Status last verified
- Jan 2024
- First submitted
- 18 Nov 2015
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23621432Pisello 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.
PubMed 19707784
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CO2 Cholangiography as an Alternative to Iodinated Contrast in Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT02611453
- Acronym / sponsor ID
- 18285
- Conditions
- Choledocholithiasis, Bile Duct Diseases, Bile Duct Carcinoma
- Keywords
- choledocholithiasis, ERCP, cholangiography, biliary stricture, bile ducts, carbon dioxide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Other: "Air" contrast cholangiography using carbon dioxide gasAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Air" contrast cholangiography using carbon dioxide gasCarbon 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). | Other | Single arm |
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.
2 secondary outcomes
Technical success of digital subtraction fluoroscopy vs. traditional fluoroscopy (while using CO2 as the contrast medium)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Background: PubMed 23621432Zhang 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.
- Background: PubMed 19707784Pisello 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.
- Individual participant dataSharing planned: No
Related trials for Choledocholithiasis
Not yet recruiting
Supraglottic Oxygenation Via Oral Transtracheal Catheter for Reducing the Incidence of Hypoxemia During ERCP Under Sedation
Choledocholithiasis With Cholecystitis With Obstruction, Obstructive Jaundice
Recruiting
ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
Cholecystectomy, Laparoscopic, Choledocholithiasis
Recruiting
Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis
Choledocholithiasis, Common Bile Duct Stones
Not yet recruiting
EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study
Cholecystectomy, Gallbladder
Recruiting
Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis
Cholelithiasis Associated With Common Bile Duct Stones
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Y. Wang, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Air" contrast cholangiography using carbon dioxide gas in people with Choledocholithiasis and Bile Duct Diseases, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success of CO2 cholangiography vs. iodinated contrast (time frame: Intraprocedural/immediate (during ERCP)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02611453, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.