Holmium laser versus electrohydraulic lithotripsy for difficult bile duct 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

This will test whether a low-power holmium laser works and is as safe as electrohydraulic lithotripsy for adults with large or hard-to-remove bile duct or pancreatic duct stones.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 19 Years to 85 Years
• Sex: All
• Sponsor: Rush University Medical Center (other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT07418112 on ClinicalTrials.gov

What this trial studies

Adults with large or otherwise difficult biliary or pancreatic duct stones undergo ERCP with single-operator cholangioscopy, and stones are fragmented using either low-wattage holmium:YAG laser lithotripsy (SOC-LL) or electrohydraulic lithotripsy (SOC-EHL). Part one evaluates safety and effectiveness of the low-wattage holmium laser, and part two is a non-inferiority comparison of stone clearance and other outcomes between SOC-LL and SOC-EHL. Procedural success, safety events, and need for additional procedures are recorded, with a follow-up phone call about 30 days after the procedure to document symptoms and adverse events. The trial is conducted at Rush University Medical Center with patients selected based on predefined criteria for “difficult” stones.

Who should consider this trial

Good fit: Adults aged 19–85 with one or more biliary or pancreatic duct stones that are large (≥15 mm), impacted, proximal to a stricture, or previously not removable by standard ERCP techniques and who can consent to ERCP are ideal candidates.

Not a fit: Patients who are pregnant, have uncorrectable coagulopathy, or have surgically altered anatomy that prevents standard ERCP access (and those with small straightforward stones) are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the low-wattage holmium laser could offer a safer or more effective option to clear large or difficult bile duct and pancreatic duct stones, potentially reducing procedure time and repeat procedures.

How similar studies have performed: Smaller series and case reports have shown laser lithotripsy can fragment difficult biliary and pancreatic stones, but prospective randomized comparisons to electrohydraulic lithotripsy have been limited.

Eligibility criteria

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.

Where this trial is running

Chicago, Illinois

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

Study contacts

• Principal investigator: Neal A Mehta, MD — Rush University Medical Center, Department of Digestive Diseases and Nutrition, Center for Interventional and Therapeutic Endoscopy
• Study coordinator: Neal A Mehta, MD

Conditions: Choledocholithiasis, Pancreatic Duct Stone, Laser lithotripsy, choledocholithiasis, pancreaticolithiasis