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Carbon Dioxide vs Iodinated Contrast for Biliary 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

Must not have

Prior history of surgery on the stomach or duodenum that precludes conventional ERCP or prior biliary tree surgery (not including cholecystectomy)

Presence of cholangitis before ERCP

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intraprocedural/immediate (during ercp)

Awards & highlights

No Placebo-Only Group

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.

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.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've had surgery on my stomach or bile ducts that affects certain procedures.

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I had cholangitis before undergoing an ERCP procedure.

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I am unable to give consent by myself.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Technical success of CO2 cholangiography vs. iodinated contrast

Secondary study objectives

Angiography, Digital Subtraction

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 4Eligibility criteria met