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

Biliary Stones Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03244163
• Other study ID #: SHOOT study
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2016
• Est. completion date: December 2026

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: John C Wong, MD
• Phone: (852)35052931
• Email: jctwong[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Stones
• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Device:
• 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
• 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.

Locations

Country	Name	City	State
Hong Kong	Endoscopy Centre, Prince of Wales Hospital	Hong Kong	NT

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall rate of endoscopic bile duct stone clearance	Overall rate of endoscopic bile duct stone clearance	Intraoperative
Secondary	Technical feasibility	Technical feasibility defined as successful introduction of cholangioscope into the CBD, visualisation and laser targeting of stone	Intraoperative
Secondary	Incidence of adverse events	Incidence of adverse events	30 days
Secondary	Need for and number of additional procedures for stone clearance	Need for and number of additional procedures for stone clearance	6 months