Holmium laser versus electrohydraulic lithotripsy for difficult bile duct and pancreatic duct stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: neal_a_mehta@rush.edu
• Phone: 3129428651

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Hyoscine Butylbromide During Transcystic Papillary Balloon Dilation for Choledocholithiasis

  This study tests whether giving hyoscine butylbromide during laparoscopic transcystic papillary balloon dilation helps patients with common bile duct stones by making the procedure faster or easier.

  Recruiting Riga East Clinical University Hospital · Riga · NCT07814976

• Intraductal antibiotic given during ERCP for acute cholangitis

  This trial tests whether putting an antibiotic directly into the bile ducts during ERCP, together with standard IV antibiotics, helps adults with mild-to-moderate acute cholangitis recover faster and avoid worsening infection compared with IV antibiotics alone.

  Recruiting Phase 2 National University of Malaysia · Cheras, Kuala Lumpur · NCT07407491

• Comparing the carbon footprint of endoscopic ultrasound versus MRCP for suspected common bile duct stones

  This project will test whether endoscopic ultrasound (EUS) produces a smaller carbon footprint than MRCP when used to check for common bile duct (CBD) stones in adults with intermediate risk.

  Recruiting Asian Institute of Gastroenterology, India · Hyderabad, Telangana · NCT07283185

• Early versus late laparoscopic gallbladder removal after clearing common bile duct stones with ERCP

  This trial will test whether having your gallbladder removed soon after ERCP or waiting longer gives better outcomes for people who had stones cleared from their common bile duct.

  Recruiting Khyber Teaching Hospital · Peshawar, Khyberpukhtunkhwa · NCT07130864

• One-stage laparoendoscopic approach for gallbladder and common bile duct stones

  This trial tests whether a single-operation laparoendoscopic 'rendezvous' approach—combining laparoscopic gallbladder removal with endoscopic bile duct clearance—works safely and effectively for patients with both gallbladder and common bile duct stones.

  Recruiting Minia University · Minya · NCT07008170

• Gallbladder removal versus watchful waiting after bile duct stone removal in older adults

  This trial tests whether immediate laparoscopic gallbladder removal or a wait-and-see approach is better for older patients after their common bile duct stones have been removed by ERCP.

  Recruiting at 2 sites Helsinki University Central Hospital · Espoo and 11 other locations · NCT07001423

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.