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 ↗
Who can join
Age 19 Years – 85 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age 19-85 years
- Signed written informed consent.
- Presence of one or more biliary (common bile duct or intrahepatic) or pancreatic duct stones that are deemed "difficult" based on at least one of the following criteria:; Stone diameter ≥ 15 mm in any single dimension as measured on prior cross-sectional imaging (CT, MRCP, or EUS).; Presence of an impacted stone that cannot be dislodged with a standard balloon or basket.; Stone located proximal to a benign biliary or pancreatic duct stricture.; Documented failure of stone extraction during a prior ERCP attempt using standard techniques (e.g., sphincterotomy with balloon/basket extraction).
You can't join if
- Pregnancy: Repeated ERCP would be delayed until after delivery if possible
- Clinically significant, uncorrectable coagulopathy (defined as INR > 1.5 or platelet count < 50,000/μL).
- Surgically altered upper gastrointestinal anatomy that precludes conventional ERCP access (e.g., Roux-en-Y gastric bypass), unless an alternative access route (e.g., laparoscopy-assisted or EUS-directed) is planned as the standard of care.
- Known or highly suspected malignant biliary or pancreatic stricture associated with the stone.
- Acute pancreatitis at the time of screening, unless it is gallstone pancreatitis with persistent biliary obstruction, for which ERCP is therapeutically indicated.
- Severe cardiopulmonary disease or other comorbidities that, in the judgment of the investigator, would make the patient an unsuitable candidate for a prolonged endoscopic procedure under general anesthesia.
- Known life expectancy of less than 6 months.
- Inability or unwillingness to comply with study procedures or follow-up requirements.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openRush University Medical Center
Chicago, Illinois, United States
- Amanda Lin, DSc, CCRC · Contact3129428651Amanda_F_Lin@rush.edu
- Neal A Mehta, MD · Contact3129428651neal_a_mehta@rush.edu
- Neal A Mehta, MD · Principal investigator
- Irving Waxman, MD · Sub-investigator
- Ajaypal Singh, MD · Sub-investigator
- Christopher G Chapman, MD · Sub-investigator
Recruiting
Study team
Sponsor
Rush University Medical Center
Study ID 24070901-IRB01
Principal investigator
Neal A Mehta, MD
Rush University Medical Center, Department of Digestive Diseases and Nutrition, Center for Interventional and Therapeutic Endoscopy
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.