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

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.

Study Overview

• Status: Recruiting
• Conditions: Choledocholithiasis; Pancreatic Duct Stone
• Intervention / Treatment: Device: Laser lithotripsy with low-wattage holmium laser; Device: Electrohydraulic lithotripsy

Detailed Description

This study aims to assess two main questions. 1: Whether low-wattage holmium:YAG laser lithotripsy (using the Quanta System Litho EVO device) is safe and effective in the management large and/or difficult bile duct or pancreatic duct stones. 2: Whether low-wattage holmium:YAG laser lithotripsy is non-inferior to electrohydraulic lithotripsy in the management of large and/or difficult gallstones.

Part one of the study will investigate whether utilizing the low-wattage holmium:YAG laser lithotripsy device via single-operator cholangioscopy (SOC-LL) is safe and effective to treat large and/or difficult choledocholithiasis or pancreaticolithiasis.

Part two of the study will be a non-inferiority study to determine if SOC-LL is non-inferior for stone clearance, among other secondary outcomes, compared to electrohydraulic lithotripsy via single-operator cholangioscopy (SOC-EHL).

Patients who meet the inclusion criteria will undergo ERCP procedures and will either undergo SOC-LL or SOC-EHL to treat their large and/or difficult choledocholithiasis or pancreaticolithiasis. Stone clearance and other procedural or safety measures will be assessed after the procedure. The patient will be monitored after the procedure for adverse events and the administration of medications or admission to the hospital will be determined by the proceduralist. Roughly 30 days after the procedure the patient will be called to assess for any adverse effects as well as to determine symptom resolution.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Neal A Mehta, MD; Phone Number: 3129428651; Email: neal_a_mehta@rush.edu
• Study Contact Backup: Name: Amanda Lin, DSc, CCRC; Email: Amanda_F_Lin@rush.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Neal A Mehta, MD; Phone Number: 3129428651; Email: neal_a_mehta@rush.edu
      • Contact: Amanda Lin, DSc, CCRC; Phone Number: 3129428651; Email: Amanda_F_Lin@rush.edu
      • Principal Investigator: Neal A Mehta, MD
      • Sub-Investigator: Irving Waxman, MD
      • Sub-Investigator: Ajaypal Singh, MD
      • Sub-Investigator: Christopher G Chapman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser Lithotripsy; 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; Use of low-wattage holmium laser for lithotripsy of large and/or difficult bile duct stones or pancreatic duct stones during ERCP.; Other Names: lithotripsy; laser lithotripsy
Active Comparator: Electrohydraulic Lithotripsy; Electrohydraulic lithotripsy (EHL). Use of EHL to break down large/difficult bile duct or pancreatic duct stones.	Device: Electrohydraulic lithotripsy; Use of electrohydraulic lithotripsy for management of large and/or difficult bile duct or pancreatic duct stones.; Other Names: EHL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall complete stone clearance rate	This describes the rate of complete stone clearance at the end of the final procedure required to completely clear stones, regardless of the number of procedures required to do so.	Immediately after the final procedure
Number of procedures	Describes the number of ERCP procedures required to achieve complete stone clearance.	Immediately after the final procedure
Total procedure time	Total duration of index ERCP procedure. Will also document total procedural time for all necessary ERCPs to achieve stone clearance.	Immediately after the final procedure
Total lithotripsy time	Duration of the activation time for either the laser lithotripsy or the electrohydraulic lithotripsy devices during the study duration.	Immediately after the final procedure
Rate of rescue mechanical lithotripsy	Describes the percentage/rate of time that the patient requires rescue mechanical lithotripsy after failure of the primary modality (SOC-LL or SOC-EHL).	Immediately after the final procedure
Length of post-procedure hospital stay	Describes the amount of time in days the patient spent in the hospital after any and all required procedures to achieve complete stone clearance.	Immediately after the final procedure

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Neal A Mehta, MD, Rush University Medical Center, Department of Digestive Diseases and Nutrition, Center for Interventional and Therapeutic Endoscopy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: choledocholithiasis; Laser lithotripsy; pancreaticolithiasis
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholelithiasis; Common Bile Duct Diseases; Choledocholithiasis; Therapeutics; Surgical Procedures, Operative; Laser Therapy; Ablation Techniques; Ultrasonic Surgical Procedures; Lithotripsy; Lithotripsy, Laser
• Other Study ID Numbers: 24070901-IRB01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Study will stay at Rush no plan for multiple centers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No