Efficacy and Safety of Laser Versus Electrohydraulic Lithotripsy for Difficult Biliary Stones: A Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
RECRUITING
Bangkok
Faculty of Medicine Siriraj Hospital, Mahidol University
RECRUITING
Bangkok
Contact Information
Primary
Ronnakorn Kongsakon, MD
ronnagorn@gmail.com
+66655979522
Backup
Chutikarn Wittayalikit, MD
Chutikarn_witt@hotmail.com
+66986899088
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 60
Treatments
Experimental: Laser Lithotripsy
Experimental: Electrohydraulic Lithotripsy
Related Therapeutic Areas
Sponsors
Collaborators: Siriraj Hospital
Leads: Mahidol University

This content was sourced from clinicaltrials.gov