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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Biliary Stones

Treatments: Device: Spyglass DS cholangioscope; Device: BML

Study type: Interventional

Funder types: Other

Identifiers

NCT03244163

SHOOT study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

LASER ARM

Experimental group

Description:

Spyglass DS cholangioscope guided laser or electrohydraulic lithotripsy

Treatment:

Device: Spyglass DS cholangioscope

CONVENTIONAL ARM

Active Comparator group

Description:

Stone removal by conventional techniques, for example BML, without laser lithotripsy

Treatment:

Device: BML