Laser versus electrohydraulic treatment for hard-to-remove common bile duct stones
Efficacy and Safety of Laser Versus Electrohydraulic Lithotripsy for Difficult Biliary Stones: A Randomized Controlled Trial
NA · Mahidol University · NCT07030829
This trial tests whether laser or electrohydraulic lithotripsy is better at breaking up difficult common bile duct stones in adults who could not have their stones removed with standard ERCP techniques.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mahidol University (other) |
| Locations | 2 sites (Bangkok, Bangkok and 1 other locations) |
| Trial ID | NCT07030829 on ClinicalTrials.gov |
What this trial studies
Participants with difficult common bile duct stones undergo single-operator cholangioscopy (SpyGlass) and lithotripsy to fragment stones that could not be removed by conventional ERCP methods. One group receives laser lithotripsy and the other receives electrohydraulic lithotripsy, with fragments removed by standard ERCP retrieval techniques. The trial compares rates of complete stone clearance, number of procedures required, and complication rates between the two approaches. Adults with large, impacted, multiple, or hard-to-reach stones are included while those with unstable vitals, uncorrected coagulopathy, or surgically altered anatomy are excluded.
Who should consider this trial
Good fit: Adults over 18 with difficult common bile duct stones (for example stones >1.5 cm, impacted stones, multiple stones, or stones not cleared by conventional ERCP) are ideal candidates.
Not a fit: Patients with surgically altered anatomy, uncorrected bleeding disorders, unstable vital signs, or who are pregnant are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the preferred method could increase first-line clearance of difficult stones, reduce repeat procedures, and lower complication rates.
How similar studies have performed: Previous case series and comparative reports using SpyGlass-directed EHL or laser lithotripsy have demonstrated successful stone fragmentation, but head-to-head randomized data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bangkok, Bangkok and 1 other locations
- Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok, Bangkok, Thailand (RECRUITING)
- Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok, Bangkok, Thailand (RECRUITING)
Study contacts
- Principal investigator: Varayu Prachayakul, MD — Mahidol University
- Study coordinator: Ronnakorn Kongsakon, MD
- Email: ronnagorn@gmail.com
- Phone: +66655979522
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Common Bile Duct Stone, Common bile duct stones, CBD stones, Difficult CBD stones, ERCP, Spyglass, Cholangioscopy, Lithrotripsy