SCC-HGAS trial
- Conditions
- nresectable malignant biliary obstruction
- Registration Number
- JPRN-jRCTs042220149
- Lead Sponsor
- Sato Junya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 46
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TRBO (Time to recurrent biliary obsturuction)
- Secondary Outcome Measures
Name Time Method (1) technical success rate<br>(2) clinical success rate<br>(3) adverse events(early, late)<br>(4) procedural time<br>(5) fluoroscopy time<br>(6) RBO rate<br>(7) cause of RBO<br>(8) cost of biliary drainage(First drainage, total)<br>(9) overall survival<br>(10) rates of peritonitis and stent migration in EUS-HGAS using the study stent