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CholedocholithiasisDevicePhase 4

What this study is

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.

What's being tested

  • Laser lithotripsy with low-wattage holmium laser

    Intervention · DEVICE

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

  • Electrohydraulic lithotripsy

    Intervention · DEVICE

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

Study details

Official title
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
Conditions
Choledocholithiasis · Pancreatic Duct Stone
Enrolling
40 people
Starts
2026-01-15
Est. completion
2027-12
Design
Single-blind, randomized, parallel groups, Phase 4
Record
View on ClinicalTrials.gov ↗