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

Recruiting now · Phase 4

Conditions studied: Choledocholithiasis, Pancreatic Duct Stone

In brief

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.

Key facts

Study ID

NCT07418112

Run by

Rush University Medical Center

People needed

40

Starts

2026-01-15

Expected to finish

2027-12-01

Last updated by the study team

2026-02-18

Who can join

Age: 19 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You 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 may not qualify 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.

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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