A Randomized Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent (Niti-S Mira-Cover II Biliary Stent) to the Common Covered Metallic Biliary Stent.
19 Years
90 Years
Both
Biliary Stricture, Malignant Neoplasms
Trial Information
A Randomized Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent (Niti-S Mira-Cover II Biliary Stent) to the Common Covered Metallic Biliary Stent.
Paclitaxel covered metal biliary stent (Niti-S Mira-Cover II Biliary Stent) is non-inferior
to common covered metal biliary stent (Niti-S Biliary Stent_ComVi type)in their patency rate
and safety at the 6 months after stenting.
Inclusion Criteria:
- Patient who submitted a written informed consent for the this trial, and 18 ~ 90
years old
- Patient who have pancreatic cancer and/or biliary cancer with mid or distal CBD
invasion
- Patient who is inoperable and/or unresectable cases of malignant pancreatic stenosis
- Patient who is attempting of endoscopic biliary metallic stenting (by ERBD) firstly
- Patient who have life expectancy at least longer than 3 months (Karnofsky score >60%)
Exclusion Criteria:
- Patient who previously had surgical biliary drainage
- Patient who carrying bleeding disorder
- Patient who have combined Hilar and/or intra-hepatic duct cancer
- Patient who is improper to endoscopic treatment
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Outcome Measure:
Accumulative Patency Rate
Outcome Time Frame:
6 months
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-001
NCT ID:
NCT01413386
Start Date:
September 2011
Completion Date:
December 2012
Related Keywords:
- Biliary Stricture
- Malignant Neoplasms
- paclitaxel
- drug eluting stent
- Neoplasms
- Cholestasis
- Constriction, Pathologic
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