Comparing two methods for removing complicated bile duct stones
Official title: Randomized Controlled Trial of Spyglass DS Peroral Cholangioscope Guided Laser Lithotripsy or Electrohydraulic Lithotripsy Versus Conventional Basket Mechanical Lithotripsy for Endoscopic Removal of Complicated Bile Duct Stones
Run by Chinese University of Hong Kong · NCT03244163 · Data updated 2026-11-12
This study is testing whether a new technique using a special camera and laser can remove complicated bile duct stones better and safer than the standard method.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 86 (estimated) |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong, NT) |
| Status | Recruiting |
| Started | June 14, 2016 |
| Main results expected | June 2026 |
| Study ends | December 2026 |
| Registry record updated | September 4, 2024 |
| Trial ID | NCT03244163 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 years old with complicated biliary stones who can provide informed consent.
✕Probably not a fit
Patients who may not benefit include those under 18, pregnant or lactating individuals, and those with certain comorbidities or anatomical issues.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study compares the effectiveness of Spyglass DS peroral cholangioscope-guided holmium:YAG laser/electrohydraulic lithotripsy with conventional basket mechanical lithotripsy for the removal of complicated bile duct stones. The current standard method has a success rate of about 70%, which decreases with larger stones, often necessitating additional interventions. The Spyglass DS technique allows for direct visualization and targeted laser fragmentation of stones during endoscopic retrograde cholangiopancreatography (ERCP). This study aims to determine which method is more effective and safe for patients with complicated biliary stones.
Why it matters
Potential benefit: If successful, this study could provide a more effective and safer method for clearing complicated bile duct stones, reducing the need for additional procedures.
How similar studies have gone: While the Spyglass DS technique is a newer approach, direct comparisons of its efficacy with conventional methods have not been previously conducted.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with complicated biliary stones * Patients older than 18 years old * Patients where informed consent can be obtained Exclusion Criteria: * Patients who cannot give informed consent * Patients under 18 years old * Pregnant or lactating patients * Patient with altered gastrointestinal/biliary anatomy * Patients with distal CBD malignant stricture from intrinsic or extrinsic causes * Patients with ongoing cholangitis or biliary pancreatitis * Patient with refractory bleeding tendencies (Platelet count \<50,000/mm3 or International Normalized Ratio \>1.5 despite correction with platelet or fresh frozen plasma transfusions) * Patients with intrahepatic segmental stones * Patients with contraindications to endoscopy due to comorbidities
Where it's running
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Endoscopy Centre, Prince of Wales Hospital
Hong Kong, Nt, Hong Kong Recruiting
Study contacts
- Principal investigator: James LAU, MD — Chinese University of Hong Kong
- Study coordinator: John C Wong, MD
- Email: jctwong@cuhk.edu.hk
- Phone: (852)35052931
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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.