NIPH Clinical Trials Search

JRCT ID: jRCTs042220149

Registered date:01/03/2023

SCC-HGAS trial

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedUnresectable malignant biliary obstruction
Date of first enrollment16/03/2023
Target sample size46
Countries of recruitment
Study typeInterventional
Intervention(s)ERCP-BD or EUS-HGAS


Primary OutcomeTRBO (Time to recurrent biliary obsturuction)
Secondary Outcome(1) technical success rate (2) clinical success rate (3) adverse events(early, late) (4) procedural time (5) fluoroscopy time (6) RBO rate (7) cause of RBO (8) cost of biliary drainage(First drainage, total) (9) overall survival (10) rates of peritonitis and stent migration in EUS-HGAS using the study stent

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
Include criteria(1) the presence of a malignant obstruction (=>2cm distal to the hilum) (2) a malignant biliary obstruction with pathologic or radiologic diagnosis (3) the statement of unresectable comfarmed by radiologic diagnosis or characteristics of patient (comorbidities or age) (4) Jaundice: serum total bilirubin =>2.0mg/dL or liver damage: at least 2 of liver enzymes (AST, ALT, ALP, or gamma-GTP) at least 2 times above the upper limit of normal. (5) Eastern Cooperative Oncology Group performance status 0-2 (6) age =>18 years old
Exclude criteria(1) a hilar biliary obstruction classificated Bismuth II or more (2) surgically altered anatomy of the stomach and the duodenum except Billroth I (3) history of choledochojejunostomy (4) vomiting and duodenal obstruction with radiologic diagnosis (5) previously performed duodenal stenting (6) less diameter of left intrahepatic bile duct (=<2mm) (7) plateler count <50000 or prothrombin time international normalized ratio =>1.5 (8) impossibility in discontinuation of antithrombotic therapy (9) the presence of massive ascites (10) life expectancy less than 3 months (11) other reasons for unsuitable statement to participate the study judged from principal investigator

Related Information


Public contact
Name Junya Sato
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
Affiliation Shizuoka Cancer Center
Scientific contact
Name Junya Sato
Address 1007Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
Affiliation Shizuoka Cancer Center