- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03244163
Spyglass DS Peroral Cholangioscope Guided LL or EHL Versus BML for Endoscopic Removal of Complicated Bile Duct Stones
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Currently, complicated bile duct stones are removed during endoscopic retrograde cholangiopancreatography (ERCP) by conventional mechanical lithotripsy, which means using a metal wire basket to capture the stone and crush it to make it easier to remove. This is successful in approximately 70% of patients, with the success rate inversely correlated to the size of the stone. Unsuccessful stone removal would require additional endoscopic, percutaneous or surgical interventions. Spyglass DS peroral cholangioscope-guided holmium:YAG laser/electrohydraulic lithotripsy is a recent alternate method for managing complicated bile duct stones. Also performed during ERCP, a thin flexible camera (called Spyglass DS peroral cholangioscope) is inserted into the bile duct to visualize the stone which can then be targeted by a laser beam for fragmentation (also known as laser lithotripsy). The smaller pieces are then removed. Direct comparisons of these procedures' efficacy however have not been performed.
The purpose of this study is to compare the efficacy and safety of Spyglass DS peroral cholangioscope-guided holmium:YAG laser/electrohydraulic lithotripsy (the laser arm) versus conventional basket mechanical lithotripsy alone (the conventional arm) for fragmentation and clearance of complicated bile duct stones.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: John C Wong, MD
- Phone Number: (852)35052931
- Email: jctwong@cuhk.edu.hk
Study Locations
-
-
NT
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Hong Kong, NT, Hong Kong
- Recruiting
- Endoscopy Centre, Prince of Wales Hospital
-
Contact:
- John C Wong, MD
- Phone Number: (852)35052931
- Email: jctwong@cuhk.edu.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LASER ARM
Spyglass DS cholangioscope guided laser or electrohydraulic lithotripsy
|
The 1.8Fr holmium:YAG laser fiber (Lumenis, Yokneam, Israel) will be inserted into the cholangioscope's working channel for lithotripsy under direct visualization.
An EHL probe may alternatively be used depending on availability.
Lithotripsy is applied until fragments of the targeted stone are no longer lumen filling, and can be dispersed easily with fluid irrigation.
Fragmented stones are then removed by a combination of conventional techniques.
To confirm stone clearance, the Spyglass DS cholangioscope will be re-introduced, and the bile duct will be examined for residual stones from the confluence of the right and left intrahepatic ducts to the papillary opening
|
Active Comparator: CONVENTIONAL ARM
Stone removal by conventional techniques, for example BML, without laser lithotripsy
|
Biliary sphincterotomy with/without EPBD to the size of the lower bile duct with a limit of 15mm will be performed.
Stones are removed by a combination of conventional BML, extraction balloon and/or baskets, without laser lithotripsy.
An occlusion cholangiogram is performed to confirm stone clearance.
In cases where stone clearance is incomplete, a plastic biliary stent bridging the stone will be inserted for temporary drainage until definitive management, usually within one month.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall rate of endoscopic bile duct stone clearance
Time Frame: Intraoperative
|
Overall rate of endoscopic bile duct stone clearance
|
Intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical feasibility
Time Frame: Intraoperative
|
Technical feasibility defined as successful introduction of cholangioscope into the CBD, visualisation and laser targeting of stone
|
Intraoperative
|
Incidence of adverse events
Time Frame: 30 days
|
Incidence of adverse events
|
30 days
|
Need for and number of additional procedures for stone clearance
Time Frame: 6 months
|
Need for and number of additional procedures for stone clearance
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James LAU, MD, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHOOT study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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