Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent(Niti-S Mira-Cover Biliary Stent ) to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent)
19 Years
90 Years
Both
Biliary Stricture, Malignant Neoplasms
Trial Information
Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent(Niti-S Mira-Cover Biliary Stent ) to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent)
Paclitaxel covered metal biliary stent(Mira-Cover Biliary Stent) extents their patency rate
comparing to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent.
Inclusion Criteria:
- Patient who is inoperable and/or unresectable cases of pancreatic cancer and/or
biliary cancer with mid or distal CBD invasion
- Among patient of a.,Patient who previously had surgical biliary drainage of plastic
stent have eligibility
Exclusion Criteria:
- Patient who have life expectancy under 3 months
- Patient who have severe metastasis of Liver or whole body
- Patient who previously had surgical biliary drainage
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Outcome Measure:
Accumulative Patency Rate
Outcome Time Frame:
6 month
Safety Issue:
Yes
Principal Investigator
Dong Ki Lee, Ph.D
Investigator Role:
Study Chair
Investigator Affiliation:
Kangnam Severance Hospital
Authority:
Korea: Food and Drug Administration
Study ID:
MIRA-cover
NCT ID:
NCT01512563
Start Date:
February 2007
Completion Date:
February 2010
Related Keywords:
- Biliary Stricture
- Malignant Neoplasms
- paclitaxel
- drug eluting stent
- Neoplasms
- Cholestasis
- Constriction, Pathologic
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