Spyglass DS Peroral Cholangioscope Guided LL or EHL Versus BML for Endoscopic Removal of Complicated Bile Duct Stones

Not Applicable

Recruiting

• Conditions: Biliary Stones
• Interventions: Device: Spyglass DS cholangioscope; Device: BML

• Registration Number: NCT03244163
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

This study aims to compare the overall rate of endoscopic clearance of complicated bile duct stones by Spyglass DS peroral cholangioscopy guided holmium:YAG laser/electrohydraulic lithotripsy versus conventional BML.

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 Timeline

• Study Start: 2016-06-14
• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-09
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-20
• Last Update Posted: 2023-08-22
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Patients with complicated biliary stones
• Patients older than 18 years old
• Patients where informed consent can be obtained

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LASER ARM	Spyglass DS cholangioscope	Spyglass DS cholangioscope guided laser or electrohydraulic lithotripsy
CONVENTIONAL ARM	BML	Stone removal by conventional techniques, for example BML, without laser lithotripsy

Primary Outcome Measures

Name	Time	Method
Overall rate of endoscopic bile duct stone clearance	Intraoperative	Overall rate of endoscopic bile duct stone clearance

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	30 days	Incidence of adverse events
Technical feasibility	Intraoperative	Technical feasibility defined as successful introduction of cholangioscope into the CBD, visualisation and laser targeting of stone
Need for and number of additional procedures for stone clearance	6 months	Need for and number of additional procedures for stone clearance

Trial Locations

Locations (1)

Endoscopy Centre, Prince of Wales Hospital; 🇭🇰 Hong Kong, NT, Hong Kong