Status:
TERMINATED
Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic Biliary Stent
Lead Sponsor:
Jong Taek, Lee
Conditions:
Biliary Stricture
Malignant Neoplasms
Eligibility:
All Genders
19-90 years
Phase:
NA
Brief Summary
Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent in their patency rate and safety at the 6 months after stenting.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2013
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01413386
Start Date
September 1 2011
End Date
April 23 2013
Last Update
March 11 2020
Active Locations (3)
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1
In Ha University Hospital
Incheon, In Chun, South Korea, 400-711
2
Kangnam Severance Hospital
Kangnam, Seoul, South Korea, 135-720
3
Asan Medical Center
Seoul, South Korea, 138-736