Recruiting

Holmium Laser vs. Electrohydraulic Lithotripsy

Sponsor:

Rush University Medical Center

Code:

NCT07418112

Conditions

Choledocholithiasis

Pancreatic Duct Stone

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Laser lithotripsy with low-wattage holmium laser

Electrohydraulic lithotripsy

Study Details

Brief summary:

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

Choledocholithiasis

Pancreatic Duct Stone

Study ID

NCT07418112

Start date

Jan 15, 2026

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Laser Lithotripsy

Laser lithotripsy (LL). Use of LL to break down large/difficult bile duct or pancreatic duct stones.

active comparator: Electrohydraulic Lithotripsy

Electrohydraulic lithotripsy (EHL). Use of EHL to break down large/difficult bile duct or pancreatic duct stones.

Interventions

Laser lithotripsy with low-wattage holmium laser

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

Electrohydraulic lithotripsy

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

Primary outcome measure

  • Complete stone clearance [ Time Frame: Immediately after the procedure ]

Central Contacts and Locations

Central contacts

Neal A Mehta, MD

3129428651neal_a_mehta@rush.edu

Amanda Lin, DSc, CCRC

Amanda_F_Lin@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Amanda Lin, DSc, CCRC

3129428651Amanda_F_Lin@rush.edu

Neal A Mehta, MD

3129428651neal_a_mehta@rush.edu

Principal Investigator:

Neal A Mehta, MD

More Information

Sponsor

Rush University Medical Center

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

  • Laser lithotripsy
  • choledocholithiasis
  • pancreaticolithiasis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-02-18.