Efficacy of the 6-mm fully covered metal stents forpatients with malignant hilar biliary obstructio
Not Applicable
- Conditions
- Neoplasms
- Registration Number
- KCT0003755
- Lead Sponsor
- Ajou University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
1. 20 years of age
2. malignant hilar biliary obstruction of Bismuth type II or higher, causing jaundice
3. cholangiocarcinoma or gallbladder cancer or metastatic cancer
4. unsuitable for curative resection due to locally advanced stage, metastasis, or high surgical risk
5. life expectancy > 4 months
Exclusion Criteria
1. hepatocellular carcinoma
2. surgically altered upper gastrointestinal anatomy following hepatobiliary or gastric surgery except cholecystectomy
3. uncontrolled coagulopathy (International normalized ratio > 1.5 or platelet count < 50,000 /mm3)
4. liver atrophy
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stent dysfunction rate
- Secondary Outcome Measures
Name Time Method early advere event;late adverse event