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Procedure

Balloon Dilation vs Lithotripsy for Gallstones

N/A

Recruiting

Led By James Buxbaum, 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 hours

Awards & highlights

Study Summary

This trial is comparing two different ways to remove large bile duct stones. One method uses a laser or EHL to break up the stones, while the other method uses dilation to remove the stones.

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.Check my eligibility

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.See study design

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

Select...

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

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

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

Primary outcome measures

First procedure stone clearance

Secondary outcome measures

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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

906 Previous Clinical Trials

1,596,198 Total Patients Enrolled

James Buxbaum, MDPrincipal InvestigatorUniversity of Southern California

6 Previous Clinical Trials

1,020 Total Patients Enrolled

Ara Sahakian, MDPrincipal InvestigatorUniversity of Southern California

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

Frequently Asked Questions

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

What is the maximum size of this scientific research project?

"Affirmative. The online data hosted on clinicaltrials.gov demonstrates that this research initiative is actively searching for 90 individuals to participate, with recruitment taking place between two sites. This investigation was first posted on September 7th 2018 and the most recent update occurred on June 14th 2022."

Answered by AI

Who has the requisite credentials to participate in this research?

"In order to qualify for this medical trial, subjects should be suffering from choledocholithiasis and between the ages of 18-115. As many as 90 participants are expected to partake in this research program."

Answered by AI

Are people able to enroll in this research program at present?

"Affirmative. Clinicaltrials.gov reports that this medical trial, first posted on September 7th 2018, is currently enrolling participants. 90 individuals are required to be recruited from 2 distinct locations."

Answered by AI