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