Unresectable malignant biliary obstruction
Conditions
Interventions
ERCP-BD or EUS-HGAS
Sponsors
Ishiwatari Hirotoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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 (=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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TRBO (Time to recurrent biliary obsturuction) | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Contacts
Public ContactHiroki Sakamoto
Shizuoka Cancer Center
Outcome results
None listed