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

NCT ID: NCT03244163

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-14
• Study Completion Date: 2026-12-31

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.

Conditions

Biliary Stones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LASER ARM

Spyglass DS cholangioscope guided laser or electrohydraulic lithotripsy

Group Type: EXPERIMENTAL

Spyglass DS cholangioscope

Intervention Type: DEVICE

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

CONVENTIONAL ARM

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

Group Type: ACTIVE_COMPARATOR

BML

Intervention Type: DEVICE

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.

Interventions

Spyglass DS cholangioscope

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

Intervention Type: DEVICE

BML

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

James Yun-wong Lau, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James LAU, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Endoscopy Centre, Prince of Wales Hospital

Hong Kong, NT, Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

John C Wong, MD

Role: CONTACT

jctwong@cuhk.edu.hk

(852)35052931

Facility Contacts

John C Wong, MD

Role: primary

jctwong@cuhk.edu.hk

(852)35052931

Other Identifiers

SHOOT study

Identifier Type: -

Identifier Source: org_study_id