Cost-Effectiveness of Spyglass Direct Visualization System Facilitated Management for the Patients With Intrahepatic Bile Duct Stone and/or Large Extrahepatic Bile Duct Stone

NCT ID: NCT04743089

Last Updated: 2021-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-11
• Study Completion Date: 2023-01-31

Brief Summary

Endoscopic retrograde cholangio-pancreatectomy (ERCP) is the most commonly used endoscopic method for the treatment of biliary diseases including choledocholithiasis. When the ERCP cannot be performed under fluoroscopy due to various reasons such as the location of disease (i.e. intrahepatic bile duct lesion) and characteristics of the bile duct (i.e. altered anatomy, stenosis etc.), percutaneous transhepatic cholangiography (PTCS) is performed as an another treatment option. However, treatment of biliary lesions via PTCS requires at least 10 days of hospitalization for hepato-cutaneous fistula formation and tract epithelial maturation for the advancement of cholangioscope, which causes a significant financial burden as well as discomfort associated with fistula formation to the patients.

The SpyGlass™ DS Direct Visualization System (Boston Scientific Corp., Natick, Mass.) can be applied directly into the bile duct via the working channel of the duodenoscope. It can directly visualize the intra-ductal lesions with high-resolution digital imaging and it also has a working channel that allows the use of forcep, electrohydraulic lithotripsy (EHL) and Holmium Laser. So, it has the advantage of being able to directly examine intraductal lesions and perform treatment under the 'endoscopic view' which enables improved sensitivity of the diagnosis and the success rate of the treatment.

Intrahepatic duct (IHD) stone is difficult to treat by ERCP under fluoroscopy because IHD lesion is far from the orifice of bile duct (ampulla of Vater) and usually accompanied with IHD stenosis that causes technical difficulty. In addition, even if the stone is located in an extrahepatic bile duct (EHD; common hepatic duct and common bile duct), it is difficult to treat by ERCP in the case of a huge stone that has risk of incarceration. Therefore in these cases, bile duct stones have been being treated by PTCS. If the SpyGlass™ DS Direct Visualization System is used for the treatment of IHD/EHD stone that is not treatable with ERCP, it have potential benefits of reducing the financial burden and patient's discomfort caused by the PTCS significantly. Thus, we will investigate the usefulness of the SpyGlass™ DS Direct Visualization System for the treatment of IHD stones and huge EHD stones in terms of cost and success rate.

In this study, we will evaluate the treatment efficacy and cost-effectiveness of the SpyGlass™ DS Direct Visualization System facilitated management for IHD/EHD stones. The efficacy, cost-effectiveness and safety will be compared with historical cohort of percutaneous transhepatic cholangiography (PTCS)

Conditions

Patients With Large or Impacted Intra- or Extra-hepatic Bile Duct Stone

Study Design

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

Study Groups

Spyglass arm

Patients who underwent IHD/EHD stone removal by ERCP with SpyGlass™ DS Direct Visualization System.

Group Type: EXPERIMENTAL

ERCP using SpyGlass™ DS Direct Visualization System

Intervention Type: DEVICE

Lithotripsy and stone removal will be performed using ERCP and Spyglass system to patients with IHD/EHD stone, which is difficult to remove through conventional ERCP. The SpyGlass™ DS Direct Visualization System will be applied directly into the bile duct via the working channel of the duodenoscope. Under the high-resolution digital imaging, lithotripsy such as EHL could be done.

PTCS arm (historical cohort)

Patients who underwent IHD/EHD stone removal by PTCS

Group Type: OTHER

PTCS

Intervention Type: OTHER

A historical cohort of patients who underwent PTCS to remove bile duct stones which is difficult to treat by ERCP.

Interventions

ERCP using SpyGlass™ DS Direct Visualization System

Lithotripsy and stone removal will be performed using ERCP and Spyglass system to patients with IHD/EHD stone, which is difficult to remove through conventional ERCP. The SpyGlass™ DS Direct Visualization System will be applied directly into the bile duct via the working channel of the duodenoscope. Under the high-resolution digital imaging, lithotripsy such as EHL could be done.

Intervention Type: DEVICE

PTCS

A historical cohort of patients who underwent PTCS to remove bile duct stones which is difficult to treat by ERCP.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. IHD stones disease that cannot be treated with the ERCP.

2. Huge EHD stone disease that required mechanical/electrohydraulic lithotripsy, according to investigator's clinical decision.

Exclusion Criteria

1. Patients who disagree with the study

2. Patients who underwent total gastrectomy

3. Patients with IHD stones located in a peripheral IHD where spyglass cannot reach

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moon Jae Chung

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

Yonsei University College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Moon Jae Chung

Role: CONTACT

mjchung@yuhs.ac

82-2-2228-1981

Facility Contacts

Moon Jae Chung

Role: primary

mjchung@yuhs.ac

82-2-2228-1981

Other Identifiers

1-2018-0031

Identifier Type: -

Identifier Source: org_study_id