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

NCT03244163 | Recruiting DMC FDA Device

• 1 other identifier: SHOOT study
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Stones

Keywords

Spyglass DS; Laser lithotripsy; Endoscopic retrograde cholangiopancreatography

Outcome Measures

Primary Outcomes (1)

• Overall rate of endoscopic bile duct stone clearance

  Overall rate of endoscopic bile duct stone clearance

  Intraoperative

Secondary Outcomes (3)

• Technical feasibility

  Intraoperative

• Incidence of adverse events

  30 days

• Need for and number of additional procedures for stone clearance

  6 months

Study Arms (2)

LASER ARM

EXPERIMENTAL

Spyglass DS cholangioscope guided laser or electrohydraulic lithotripsy

Device: Spyglass DS cholangioscope

CONVENTIONAL ARM

ACTIVE COMPARATOR

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

Device: BML

Interventions

Spyglass DS cholangioscope 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

LASER ARM

BML 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.

CONVENTIONAL ARM

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Endoscopy Centre, Prince of Wales Hospital

Hong Kong, NT, Hong Kong

RECRUITING

MeSH Terms

Conditions

Cholecystolithiasis

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Study Officials

• James LAU, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John C Wong, MD

CONTACT

(852)35052931; jctwong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 9, 2017
• Study Start: June 14, 2016
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)