NCT07030829 Laser vs Electrohydraulic Lithotripsy for Difficult CBD Stones
| NCT ID | NCT07030829 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mahidol University |
| Condition | Common Bile Duct Stone |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-03-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Pregnancy * Unstable vital signs * Severe comorbidities * Uncorrected coagulopathy * Surgically altered anatomy * Unable to complete informed consent
Contact & Investigator
Varayu Prachayakul, MD
PRINCIPAL INVESTIGATOR
Mahidol University
Frequently Asked Questions
Who can join the NCT07030829 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Common Bile Duct Stone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07030829 currently recruiting?
Yes, NCT07030829 is actively recruiting participants. Contact the research team at ronnagorn@gmail.com for enrollment information.
Where is the NCT07030829 trial being conducted?
This trial is being conducted at Bangkok, Thailand, Bangkok, Thailand.
Who is sponsoring the NCT07030829 clinical trial?
NCT07030829 is sponsored by Mahidol University. The principal investigator is Varayu Prachayakul, MD at Mahidol University. The trial plans to enroll 60 participants.