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

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)

Study Overview

• Status: Recruiting
• Conditions: Patients With Large or Impacted Intra- or Extra-hepatic Bile Duct Stone
• Intervention / Treatment: Device: ERCP using SpyGlass™ DS Direct Visualization System; Other: PTCS

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moon Jae Chung; Phone Number: 82-2-2228-1981; Email: mjchung@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yonsei University College of Medicine
    • Contact: Moon Jae Chung; Phone Number: 82-2-2228-1981; Email: mjchung@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spyglass arm; Patients who underwent IHD/EHD stone removal by ERCP with SpyGlass™ DS Direct Visualization System.	Device: 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.
Other: PTCS arm (historical cohort); Patients who underwent IHD/EHD stone removal by PTCS	Other: PTCS; A historical cohort of patients who underwent PTCS to remove bile duct stones which is difficult to treat by ERCP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total hospital stay (# of days)	Total hospital day	from admission to 1 month after discharge
Total procedure-related cost	Total cost from the date of admission and until date of first out-patient clinic follow-up	from admission to 1 month after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy; Technical success rate	successful complete stone removal	1. after a month of ERCP procedure 2. after 3 months of ERCP procedure
Safety; Procedure-related complication rate		1. after a month of ERCP procedure 2. after 3 months of ERCP procedure

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Moon Jae Chung, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2020
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Calculi
• Other Study ID Numbers: 1-2018-0031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No