SCC-HGAS trial

JRCT ID: jRCTs042220149

Registered date:01/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unresectable malignant biliary obstruction
• Date of first enrollment: 16/03/2023
• Target sample size: 46
• Study type: Interventional
• Intervention(s): ERCP-BD or EUS-HGAS

Outcome(s)

• Primary Outcome: TRBO (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 maximum: Not applicable
• Gender: Both

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

• Primary Sponsor: Sato Junya