RecruitingNot ApplicableNCT07030829

Laser vs Electrohydraulic Lithotripsy for Difficult CBD Stones

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


Sponsor

Mahidol University

Enrollment

60 participants

Start Date

Mar 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria6

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

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Interventions

DEVICELaser Lithotripsy

Laser Lithotripsy

DEVICEElectrohydraulic Lithotripsy

Electrohydraulic Lithotripsy


Locations(2)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, Thailand

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, Thailand

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NCT07030829