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"Air" contrast cholangiography using carbon dioxide gas for Gallstone Disease

N/A

Waitlist Available

Led By Andrew Y. Wang, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with choledocholithiasis, benign biliary strictures, malignant biliary strictures

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraprocedural/immediate (during ercp)

Awards & highlights

Study Summary

This trial will compare the use of carbon dioxide to conventional iodinated contrast for radiographic cholangiograms in patients with biliary tract disease.

Who is the study for?

This trial is for adults with biliary tract diseases, like gallstones or ductal cancers, confirmed by imaging tests. It's not suitable for pregnant individuals, those with current cholangitis, prior stomach/duodenum surgery that affects ERCP access (except gallbladder removal), inability to cannulate the bile duct during procedure, very short life expectancy, prisoners, or anyone unable to consent.Check my eligibility

What is being tested?

The study is testing if using carbon dioxide gas as a contrast agent during an ERCP procedure provides clearer images compared to traditional iodinated contrast agents. The goal is to see which method works better for patients with different biliary conditions.See study design

What are the potential side effects?

Potential side effects of using carbon dioxide in this context are usually mild and may include abdominal discomfort and bloating. There might be risks associated with the ERCP procedure itself such as pancreatitis or infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have bile duct stones or narrowing, which could be non-cancerous or cancerous.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intraprocedural/immediate (during ercp)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intraprocedural/immediate (during ercp)

This trial's timeline: 3 weeks for screening, Varies for treatment, and intraprocedural/immediate (during ercp) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Technical success of CO2 cholangiography vs. iodinated contrast

Secondary outcome measures

Angiography, Digital Subtraction

Technical success of digital subtraction fluoroscopy vs. traditional fluoroscopy (while using CO2 as the contrast medium)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single armExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

753 Previous Clinical Trials

1,244,991 Total Patients Enrolled

Andrew Y. Wang, MDPrincipal InvestigatorUniversity of Virginia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process for this trial still open?

"The clinical trial hosted on the website clinicaltrials.gov indicates that this specific study is not actively enrolling participants, having been posted in February of 2016 and last updated in June 2022. However, there are presently 98 other trials searching for patients to join their team."

Answered by AI

Recent research and studies

Langenbeck's Archives of SurgeryJournal

Cholangitis Prevention in Endoscopic Klatskin Tumor Palliation: Air Cholangiography Technique

Pisello, Franco, Girolamo Geraci, Giuseppe Modica, and Carmelo Sciumè. 2009. “Cholangitis Prevention in Endoscopic Klatskin Tumor Palliation: Air Cholangiography Technique”. Langenbeck's Archives of Surgery. Springer Science and Business Media LLC. doi:10.1007/s00423-009-0548-y.

Scandinavian Journal of GastroenterologyJournal

Effect of Co<sub>2</sub>cholangiography on Post-ercp Cholangitis in Patients with Unresectable Malignant Hilar Obstruction – a Prospective, Randomized Controlled Study

Zhang, Rongchun, Lina Zhao, Zhiguo Liu, Biaoluo Wang, Na Hui, Xiangping Wang, Rui Huang, et al.. 2013. “Effect of Co2cholangiography on Post-ercp Cholangitis in Patients with Unresectable Malignant Hilar Obstruction – a Prospective, Randomized Controlled Study”. Scandinavian Journal of Gastroenterology. Informa UK Limited. doi:10.3109/00365521.2013.779745.

clinicaltrials.govStudy

Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP

Andrew Y Wang, MD 2016. "Cholangiography Using Carbon Dioxide Versus Iodinated Contrast in ERCP". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02611453.

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