Laser versus electrohydraulic treatment for hard-to-remove common bile duct stones
Official title: Efficacy and Safety of Laser Versus Electrohydraulic Lithotripsy for Difficult Biliary Stones: A Randomized Controlled Trial
Run by Mahidol University · NCT07030829 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Mahidol University Academic / other |
| Locations | 2 sites (Bangkok, Bangkok and 1 other locations) |
| Status | Recruiting |
| Started | March 1, 2025 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | June 22, 2025 |
| Trial ID | NCT07030829 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Balance exergame training for older adults who have fallen
This study tests balance-based video game training versus conventional balance training to see if it improves balance, brain activity, and function in older adults who have fallen before.
-
High BMI and periodontitis in Thai adults under 60
This study tests how common high BMI and periodontitis are among Thai adults aged 18–59 and what factors are linked to them.
-
Cardiovascular Risk in Thai MASLD Patients: Coronary Calcium Scores
This study tests how well common cardiovascular risk tools align with coronary calcium scores in Thai adults with MASLD who have no heart symptoms.
-
HSCT outcomes in children at Ramathibodi Hospital
This study tests how hematopoietic stem cell transplantation works in pediatric patients with blood diseases, cancers, and other conditions at Ramathibodi Hospital.
-
Shrimp Sensitization and Allergy in Edible Insect Allergy
This study tests whether people 7 and older who are allergic to edible insects also show shrimp sensitization or shrimp allergy, by using tests and risk-based food challenges.
-
Long-term Iron Absorption in Women with Overweight/Obesity vs Normal Weight
This study tests long-term iron absorption and loss in women aged 40–50, comparing those who are overweight/obese with those of normal weight.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.