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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

Who can join

Ages 19 to 85 · All sexes

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

About the study

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 is being tested

• Laser lithotripsy with low-wattage holmium laser (device)
• Electrohydraulic lithotripsy (device)

Sponsor: Rush University Medical Center · Participants: 40 · Started: Jan 15, 2026

Contact the study team

• Neal A Mehta, MD · Phone: 3129428651

Official record on ClinicalTrials.gov — NCT07418112

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.