What side effects are associated with this type of intervention?

Common side effects of treatments for gallstone disease, such as cholangioscopy guided intraductal lithotripsy, include mild to moderate pain, infection, pancreatitis, and bile duct injury. Rare but serious complications can include bleeding, perforation of the bile duct, and cholangitis. These procedures are generally well-tolerated but require careful patient selection and skilled execution to minimize risks.

What prior FDA approvals exist?

The FDA has approved several treatments for Gallstone Disease, including non-surgical options like ursodeoxycholic acid, which helps dissolve cholesterol gallstones. For more direct interventions, endoscopic techniques such as Endoscopic Retrograde Cholangiopancreatography (ERCP) with sphincterotomy and stone extraction are commonly used. Cholangioscopy Guided Intraductal Lithotripsy, which involves direct visualization and fragmentation of bile duct stones using laser or electrohydraulic energy, represents an advanced method for managing difficult-to-remove stones. While specific FDA approvals for this exact technique may not be detailed, it aligns with the broader category of endoscopic and minimally invasive procedures that have been validated for safety and efficacy in treating bile duct stones.

What other types of research exist?

Promising, novel alternatives to Cholangioscopy Guided Intraductal Lithotripsy for gallstone disease patients include endoscopic gallbladder drainage and EUS-guided cholecystostomy. These techniques are particularly useful for high-risk surgical patients and offer less invasive options for managing gallstone-related complications.

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Procedure

Balloon Dilation vs Lithotripsy for Gallstones

N/A

Recruiting

Led By Ara Sahakian, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

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

Must have

Undergoing ERCP at LAC+Medical Center or Keck Hospital of USC for the standard indication of bile duct stones with evidence of a large stone (>1cm) demonstrated either on Ultrasound, computed tomography, prior ERCP, or magnetic resonance imaging.

Be older than 18 years old

Must not have

Patients Under the age of 18

Patients with biliary malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two methods for removing large bile duct stones in patients where standard methods fail. One method uses a camera and laser/electric shock to break up the stones, while the other uses a balloon to widen the duct opening. The goal is to see which method is more effective, safer, quicker, and less costly.

Who is the study for?

This trial is for adults over 18 with gallstone disease, specifically those with large bile duct stones (>1cm) confirmed by imaging tests. It's not for pregnant individuals, prisoners, those unable to consent, under-18s, or patients with biliary cancer or past stomach or biliary surgeries.

What is being tested?

The study compares two methods of removing large bile duct stones: one starts with papillary balloon dilation and the other begins with intraductal lithotripsy using cholangioscopy guidance. The focus is on effectiveness, safety, time needed and costs.

What are the potential side effects?

Potential side effects may include discomfort at the procedure site, bleeding, infection risk from the interventions and possible complications related to endoscopic procedures such as pancreatitis.

Eligibility Criteria

Inclusion Criteria

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

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I am having an ERCP for a large bile duct stone at a specified hospital.

Exclusion Criteria

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

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I am younger than 18 years old.

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I have cancer of the bile ducts.

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I have had surgery to reroute my bile flow.

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I have had gastric bypass surgery.

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I am unable to give consent by myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

First procedure stone clearance

Secondary study objectives

Adverse Events

Procedure Time

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Intraductal lithotripsyActive Control1 Intervention

Cholangioscopy enables therapeutic intervention including intracorporeal electro-hydraulic and laser lithotripsy for biliary stone disease with favorable efficacy and safety.

Group II: Papillary Balloon dilationActive Control1 Intervention

Balloon dilation of the Ampulla of Vater after a small sphincterotomy is an alternative technique that allows for removal of large bile duct stones in a safe and effective manner.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cholangioscopy guided intraductal lithotripsy is a treatment for gallstone disease that involves the direct visualization and fragmentation of bile duct stones using laser or electrohydraulic energy. This method allows for precise targeting and breaking down of stones, which can then be more easily removed or passed naturally. The direct visualization aspect ensures that the procedure is accurate and minimizes damage to surrounding tissues. This is particularly important for patients as it reduces the risk of complications, shortens recovery time, and improves overall outcomes compared to more invasive surgical options. Other common treatments for gallstone disease include endoscopic retrograde cholangiopancreatography (ERCP) with stone extraction and oral bile acid dissolution therapy, which work by either mechanically removing the stones or chemically dissolving them, respectively.