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

Last updated: September 1, 2024
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disorders

Gall Bladder Disorders

Treatment

BML

Spyglass DS cholangioscope

Clinical Study ID

NCT03244163
SHOOT study
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with complicated biliary stones

  • Patients older than 18 years old

  • Patients where informed consent can be obtained

Exclusion

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 orInternational Normalized Ratio >1.5 despite correction with platelet or fresh frozenplasma transfusions)

  • Patients with intrahepatic segmental stones

  • Patients with contraindications to endoscopy due to comorbidities

Study Design

Total Participants: 86
Treatment Group(s): 2
Primary Treatment: BML
Phase:
Study Start date:
June 14, 2016
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Endoscopy Centre, Prince of Wales Hospital

    Hong Kong, NT
    Hong Kong

    Site Not Available

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