An interventional study of ERCP using SpyGlass™ DS Direct Visualization System and PTCS in Patients With Large or Impacted Intra- or Extra-hepatic Bile Duct Stone, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-02-08.
Sponsored by Yonsei University · Not applicable, Interventional, and Treatment
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)
292 studies on the registry are indexed under Calculi; 38 are open to participants now.
This study's planned enrollment of 20 is below the median of 100 across 223 interventional studies indexed under Calculi.
Browse Calculi studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who underwent IHD/EHD stone removal by ERCP with SpyGlass™ DS Direct Visualization System.
Device: ERCP using SpyGlass™ DS Direct Visualization System
Patients who underwent IHD/EHD stone removal by PTCS
Other: PTCS
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.
A historical cohort of patients who underwent PTCS to remove bile duct stones which is difficult to treat by ERCP.
Total hospital stay (# of days)
Total hospital day
Time frame: 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
Time frame: from admission to 1 month after discharge
Efficacy; Technical success rate
successful complete stone removal
Time frame: 1. after a month of ERCP procedure 2. after 3 months of ERCP procedure
Safety; Procedure-related complication rate
Time frame: 1. after a month of ERCP procedure 2. after 3 months of ERCP procedure
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Yonsei University