Unique ID issued by UMIN | UMIN000002293 |
---|---|
Receipt number | R000002802 |
Scientific Title | A Multi-Center, Prospective Study of Covered WallFlex Biliary Metallic Stent for extrahepatic malignant biliary obstruction |
Date of disclosure of the study information | 2009/08/08 |
Last modified on | 2015/12/11 08:22:20 |
A Multi-Center, Prospective Study of Covered WallFlex Biliary Metallic Stent for extrahepatic malignant biliary obstruction
WATCH study
A Multi-Center, Prospective Study of Covered WallFlex Biliary Metallic Stent for extrahepatic malignant biliary obstruction
WATCH study
Japan |
Malignant biliary obstruction
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate clinical efficacy of Covered WallFlex for unresectable extrahepatic malignant biliary obstruction, in comparison with 138 cases of covered Wallstent as a historical control.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Stent patency period
Stent occlusion rate, Stent-related complication rate, Event free survival, overall survival, success rate of stent removal
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Device,equipment |
Covered WallFlex biliary stent
Not applicable |
Not applicable |
Male and Female
:Unresectable extrahepatic malignant biliary obstruction
:Not limited by primary disease, age, and sex
:Patients with written informed consent
:Patients for whom endoscopic biliary drainage is difficult.
:Patients with hilar malignant biliary obstruction
:Patients with duodenal obstruction
:Patients with massive ascites
:Patients with performance status>=3
:Patients with severely impaired organ
function
:Patients without written informed consent
:Patients considered ineligible for this
study.
80
1st name | |
Middle name | |
Last name | Hiroyuki Isayama |
Faculty of Medicine, University of Tokyo
Department of Gastroenterology
7-3-1, Hongo, Bunkyo-ku, Tokyo
03-3815-5411
1st name | |
Middle name | |
Last name | Yousuke Nakai |
Faculty of Medicine, University of Tokyo
Department of Gastroenterology
7-3-1, Hongo, Bunkyo-ku, Tokyo
03-3815-5411
Faculty of Medicine, University of Tokyo
Faculty of Medicine, University of Tokyo
Self funding
NO
2009 | Year | 08 | Month | 08 | Day |
Published
http://www.sciencedirect.com/science/article/pii/S0016510712002040
Main results already published
2009 | Year | 05 | Month | 31 | Day |
2009 | Year | 06 | Month | 01 | Day |
2009 | Year | 09 | Month | 01 | Day |
2009 | Year | 08 | Month | 04 | Day |
2015 | Year | 12 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002802
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Research case data | |
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