RecruitingPhase 4NCT07418112

Comparing the Efficacy and Safety of Holmium Laser Lithotripsy Versus Electrohydraulic Lithotripsy for the Treatment of Difficult Choledocholithiasis and Pancreatic Duct Stones

Comparing the Efficacy and Safety of Holmium Laser Lithotripsy Versus Electrohydraulic Lithotripsy for the Treatment of Difficult Choledocholithiasis and Pancreatic Duct Stones: A Randomized Controlled Trial

Sponsor

Rush University Medical Center

Enrollment

40 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

Choledocholithiasis Pancreatic Duct Stone

Summary

The goal of this clinical trial is to learn if a low-power holmium laser works to treat large and/or difficult bile duct or pancreatic duct stones in adults. It will also learn about the safety of the low-wattage holmium laser. The main questions it aims to answer are: Is the low-power holmium laser effective at treating large and/or difficult bile duct or pancreatic duct stones? Is the low-power holmium laser effective safe to use in adults? How does the low-power holmium laser compare to electrohydraulic lithotripsy for the management of large and/or difficult bile duct or pancreatic duct stones. Participants will: Undergo ERCP procedure and their bile duct or pancreatic duct stone will either be broken up with the low-power holmium laser lithotripsy device or the electrohydraulic lithotripsy lithotripsy device. Answer a call 30 days after the procedure to document symptoms and/or any side effects.

Eligibility

Min Age: 19 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study compares two methods for breaking up and removing stubborn stones in the bile duct or pancreatic duct that are hard to treat with standard techniques: holmium laser lithotripsy (using laser energy) versus electrohydraulic lithotripsy (using electrical shock waves), both delivered through a thin scope. **You may be eligible if...** - You are 19 to 85 years old - You have one or more bile duct or pancreatic duct stones considered "difficult" (e.g., larger than 15 mm, impacted, or irregularly shaped) - You have signed informed consent **You may NOT be eligible if...** - Your stones can be removed with standard methods - You fall outside the age range - You have contraindications to the procedure Talk to your doctor to see if this trial is right for you.

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Interventions

DEVICELaser lithotripsy with low-wattage holmium laser

Use of low-wattage holmium laser for lithotripsy of large and/or difficult bile duct stones or pancreatic duct stones during ERCP.

DEVICEElectrohydraulic lithotripsy

Use of electrohydraulic lithotripsy for management of large and/or difficult bile duct or pancreatic duct stones.

Locations(1)

Rush University Medical Center

Chicago, Illinois, United States

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NCT07418112

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