臨床研究等提出・公開システム

A randomized controlled trial comparing ERCP-BD versus EUS-HGAS as
the first line palliative drainage for malignant biliary obstruction

SCC-HGAS trial

Ishiwatari Hirotoshi

Shizuoka Cancer Center

1007Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka

h.ishiwatari@scchr.jp

Sakamoto Hiroki

Shizuoka Cancer Center

1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka

+81-55-989-5222

h.sakamoto@scchr.jp

Not Recruiting

Mar. 01, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

(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

Both

Unresectable malignant biliary obstruction

ERCP-BD or EUS-HGAS

TRBO (Time to recurrent biliary obsturuction)

(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

+81-55-989-5222

Feb. 15, 2023

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