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

NCT07418112 | Recruiting Phase 4 FDA Device

• 1 other identifier: 24070901-IRB01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Laser lithotripsy; choledocholithiasis; pancreaticolithiasis

Outcome Measures

Primary Outcomes (1)

• Complete stone clearance

  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.

  Immediately after the procedure

Secondary Outcomes (6)

• Overall complete stone clearance rate

  Immediately after the final procedure

• Number of procedures

  Immediately after the final procedure

• Total procedure time

  Immediately after the final procedure

• Total lithotripsy time

  Immediately after the final procedure

• Rate of rescue mechanical lithotripsy

  Immediately after the final procedure

Study Arms (2)

Laser Lithotripsy

EXPERIMENTAL

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

Device: Laser lithotripsy with low-wattage holmium laser

Electrohydraulic Lithotripsy

ACTIVE COMPARATOR

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

Device: Electrohydraulic lithotripsy

Interventions

Laser lithotripsy with low-wattage holmium laser DEVICE

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

Also known as: laser lithotripsy, lithotripsy

Laser Lithotripsy

Electrohydraulic lithotripsy DEVICE

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

Also known as: EHL

Electrohydraulic Lithotripsy

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (1)

• ASGE Standards of Practice Committee; Buxbaum JL, Abbas Fehmi SM, Sultan S, Fishman DS, Qumseya BJ, Cortessis VK, Schilperoort H, Kysh L, Matsuoka L, Yachimski P, Agrawal D, Gurudu SR, Jamil LH, Jue TL, Khashab MA, Law JK, Lee JK, Naveed M, Sawhney MS, Thosani N, Yang J, Wani SB. ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis. Gastrointest Endosc. 2019 Jun;89(6):1075-1105.e15. doi: 10.1016/j.gie.2018.10.001. Epub 2019 Apr 9.

  PMID: 30979521 BACKGROUND

MeSH Terms

Conditions

Choledocholithiasis

Interventions

Lithotripsy, Laser; Lithotripsy

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Ultrasonic Surgical Procedures

Study Officials

• Neal A Mehta, MD

  Rush University Medical Center, Department of Digestive Diseases and Nutrition, Center for Interventional and Therapeutic Endoscopy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neal A Mehta, MD

CONTACT

3129428651; neal_a_mehta@rush.edu

Amanda Lin, DSc, CCRC

CONTACT

Amanda_F_Lin@rush.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: EHL vs. Laser lithotripsy for choledocholithiasis or pancreaticolithiasis. Single-blind RCT.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 18, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)