A prospective study for evaluation of efficacy of a 12mm diameter polytetrafluoroethylene partial covered stent in malignant extrahepatic biliary obstructio
- Conditions
- Neoplasms
- Registration Number
- KCT0005989
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 161
1) Adult patients aged 19 to under 80 years of age
2) Patients who are closed to malignancy, which is not surgical or resectable
3) Patients with obstructive obstruction caused by lymph node metastasis in the primary carcinoma other than the liver
4) Patients who cannot or fail endoscopic stent implantation
5) Patients who have not previously undergone bile duct surgery
6) Patients with an expected survival rate of at least 2 months (Eastern Cooperative Oncology Group Performance Status [ECOG-PS] less than 3 points)
1) Patients who had previously undergone endoscopic stent implantation or bile duct surgery
2) Patients with expansion of biliary tract in the liver or external biliary tract in the liver
3) Hemophilia patients
4) Patients with three or more ECOG points
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Opening rate: Opening rate of 12mm diameter PTFE covered stent for treatment of malignant extrahepatic biliary obstruction.
- Secondary Outcome Measures
Name Time Method Analysis of complications related to treatment;Analysis of survival rate of patients