Laser vs Electrohydraulic Lithotripsy for Difficult CBD Stones

NCT07030829 | Recruiting DMC

• 1 other identifier: SI 066/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Common bile duct (CBD) stones are a frequent condition that can lead to severe complications if not treated. The standard approach involves endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy and stone extraction using balloons or baskets. However, approximately 10-15% of cases involve "difficult CBD stones" that cannot be removed using conventional methods. According to the European Society of Gastrointestinal Endoscopy (ESGE), difficult CBD stones are characterized by large size (≥15 mm), impaction, multiple stones, difficult locations (e.g., intrahepatic or cystic ducts), or altered anatomy due to previous surgeries. These cases require advanced techniques such as single-operator cholangioscopy (SOC) using the SpyGlass DS system, which allows direct stone visualization and lithotripsy-assisted fragmentation. Two primary lithotripsy methods are available: Electrohydraulic Lithotripsy (EHL): Uses shock waves from electrical energy to break stones. Laser Lithotripsy (LL): Uses laser energy to fragment stones through a water-mediated medium. While both techniques are effective, studies suggest LL has a higher first-attempt stone clearance rate (82-100%) compared to EHL (70.9-75%). However, EHL is more cost-effective and widely available, whereas LL offers greater precision but at a higher cost. Currently, no randomized controlled trial (RCT) directly compares their efficacy, procedural time, complication rates, or operator satisfaction. This study aims to fill that gap by conducting a randomized trial comparing EHL and LL in the treatment of difficult CBD stones. The primary outcome is the success rate of complete stone clearance in the first session, while secondary outcomes include procedural duration, post-procedural complications, and operator satisfaction. The findings will provide critical evidence for optimizing endoscopic stone management, improving patient outcomes, and guiding healthcare resource allocation.

Conditions

Common Bile Duct Stone

Keywords

Common bile duct stones; CBD stones; Difficult CBD stones; ERCP; Spyglass; Cholangioscopy; Lithrotripsy; Laser lithrotripsy; EHL; Electrohydraulic Lithotripsy

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Electrohydraulic Lithotripsy (EHL) and Laser Lithotripsy (LL)

  Comparison of the effectiveness of Electrohydraulic Lithotripsy (EHL) and Laser Lithotripsy (LL) by examining the success rate of complete stone removal on the first procedure.

  During the procedure

Secondary Outcomes (5)

• Procedure time

  Periprocedural (Total procedure time usually 1-2 hours)

• Number of catheters used

  Periprocedural

• Physician satisfaction

  Periprocedural

• Procedure-related adverse events

  up to 2 weeks after the procedure

• Length of hospital stay

  through after procedure average 1-2 weeks

Study Arms (2)

Laser Lithotripsy

EXPERIMENTAL

Device: Laser Lithotripsy

Electrohydraulic Lithotripsy

EXPERIMENTAL

Device: Electrohydraulic Lithotripsy

Interventions

Laser Lithotripsy DEVICE

Laser Lithotripsy

Laser Lithotripsy

Electrohydraulic Lithotripsy DEVICE

Electrohydraulic Lithotripsy

Electrohydraulic Lithotripsy

Eligibility Criteria

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

You may qualify if:

• Aged \>18 years
• Difficult CBD stone
• Large CBD stone (stone \> 1.5 cm) or Stone impaction or CBD stones that were not completely removed using conventional techniques.

You may not qualify if:

• Pregnancy
• Unstable vital signs
• Severe comorbidities
• Uncorrected coagulopathy
• Surgically altered anatomy
• Unable to complete informed consent

Sponsors & Collaborators

• Mahidol University: lead
• Siriraj Hospital: collaborator

Study Sites (2)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10120, Thailand

RECRUITING

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10ึ700, Thailand

RECRUITING

MeSH Terms

Conditions

Gallstones

Interventions

Lithotripsy, Laser; Lithotripsy

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Varayu Prachayakul, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronnakorn Kongsakon, MD

CONTACT

+66655979522; ronnagorn@gmail.com

Chutikarn Wittayalikit, MD

CONTACT

+66986899088; Chutikarn_witt@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: June 22, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Other researchers can contact us anytime.
• Access Criteria: We will provide our protocol and/or data upon request.

Locations

TH (2)