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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

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 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

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.

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.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
941 Previous Clinical Trials
1,604,138 Total Patients Enrolled
Ara Sahakian, MDPrincipal InvestigatorUniversity of Southern California
James Buxbaum, MDPrincipal InvestigatorUniversity of Southern California
6 Previous Clinical Trials
1,020 Total Patients Enrolled

Media Library

Initial therapy with intraductal lithotripsy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03536247 — N/A
Gallstone Disease Research Study Groups: Intraductal lithotripsy, Papillary Balloon dilation
Gallstone Disease Clinical Trial 2023: Initial therapy with intraductal lithotripsy Highlights & Side Effects. Trial Name: NCT03536247 — N/A
Initial therapy with intraductal lithotripsy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03536247 — N/A
~1 spots leftby Dec 2024