Actively Recruiting
Comparing the Efficacy and Safety of Holmium Laser Lithotripsy Versus Electrohydraulic Lithotripsy for the Treatment of Difficult Choledocholithiasis and Pancreatic Duct Stones
Led by Rush University Medical Center · Updated on 2026-02-18
40
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparing the Efficacy and Safety of Holmium Laser Lithotripsy Versus Electrohydraulic Lithotripsy for the Treatment of Difficult Choledocholithiasis and Pancreatic Duct Stones
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19-85 years
- Signed written informed consent
- Presence of one or more biliary or pancreatic duct stones considered "difficult" by at least one of these: stone diameter ≥ 15 mm on imaging, impacted stone not removable with standard balloon or basket, stone located beyond a benign duct stricture, or prior failed stone extraction by ERCP with standard methods
You will not qualify if you...
- Pregnancy (repeat ERCP delayed until after delivery if possible)
- Clinically significant, uncorrectable coagulopathy (INR > 1.5 or platelet count < 50,000/µL)
- Surgically altered upper gastrointestinal anatomy preventing conventional ERCP access unless alternative access planned
- Known or suspected malignant biliary or pancreatic stricture with the stone
- Acute pancreatitis at screening except gallstone pancreatitis with persistent biliary obstruction needing ERCP
- Severe cardiopulmonary disease or other conditions making prolonged endoscopic procedure unsafe
- Life expectancy less than 6 months
- Inability or unwillingness to follow study procedures or attend follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
N
Neal A Mehta, MD
CONTACT
A
Amanda Lin, DSc, CCRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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