None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Opening rate: Opening rate of 12mm diameter PTFE covered stent for treatment of malignant extrahepatic biliary obstruction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of complications related to treatment;Analysis of survival rate of patients | — |
Countries
Korea, Republic of
Contacts
S&G Biotech