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Comparing Holmium Laser Lithotripsy and Electrohydraulic Lithotripsy for Difficult Bile Duct and Pancreatic Duct Stones

This study is comparing two ways to treat large or difficult stones in your bile ducts (choledocholithiasis) or pancreatic ducts (pancreatic duct stones): low-wattage holmium laser lithotripsy and electrohydraulic lithotripsy. Researchers want to see if the low-wattage holmium laser is safe and effective, and how it compares to electrohydraulic lithotripsy for clearing these stones. You might be able to join if you are between 19 and 85 years old and have a bile duct or pancreatic duct stone that is considered difficult, for example, if it's 15mm or larger. The main goal is to see if the stones are completely cleared right after the procedure. The study plans to enroll 40 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 40 participants. It will compare two different treatments for difficult stones: low-wattage holmium laser lithotripsy and electrohydraulic lithotripsy.
What's involved
You would undergo an ERCP procedure where either low-wattage holmium laser lithotripsy or electrohydraulic lithotripsy would be used to treat your stones. Stone clearance and other measures will be checked after the procedure.
Compensation
Not stated in the trial record.
Follow-up
Stone clearance is measured immediately after the procedure. You will be monitored after the procedure for any side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07418112

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

Recruiting
PHASE4Ages 19–85InterventionalTreatment
Rush University Medical Center
~40 participants
Updated 2026-02-18 on ClinicalTrials.gov
What's tested:Laser lithotripsy with low-wattage holmium laserElectrohydraulic lithotripsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete stone clearance
Measured over Immediately after the procedure

Conditions

Choledocholithiasis
Pancreatic Duct Stone

Explore related trials

CholedocholithiasisPancreatic Duct Stone

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Neal A Mehta, MD · PRINCIPAL_INVESTIGATOR · Rush University Medical Center, Department of Digestive Diseases and Nutrition, Center for Interventional and Therapeutic Endoscopy

Who to contact

Neal A Mehta, MD
[email protected]
3129428651
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Complete stone clearanceImmediately after the procedure

    Complete stone clearance is defined as the lithotripsy and clearance of ductal stone fragments as confirmed on cholangiogram or pancreaticogram at the end of the index/first procedure of the study.