Unique ID issued by UMIN | UMIN000004456 |
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Receipt number | R000005335 |
Scientific Title | A Multi-Center, Prospective Study of Partially Covered WallFlex Biliary Metallic Stent for extrahepatic malignant biliary obstruction(Safety for elderly patients) |
Date of disclosure of the study information | 2010/11/01 |
Last modified on | 2012/05/11 07:21:42 |
A Multi-Center, Prospective Study of Partially Covered WallFlex Biliary Metallic Stent for extrahepatic malignant biliary obstruction(Safety for elderly patients)
A Multi-Center, Prospective Study of Covered WallFlex Biliary Metallic Stent for extrahepatic malignant biliary obstruction(Safety for elderly patients)
A Multi-Center, Prospective Study of Partially Covered WallFlex Biliary Metallic Stent for extrahepatic malignant biliary obstruction(Safety for elderly patients)
A Multi-Center, Prospective Study of Covered WallFlex Biliary Metallic Stent for extrahepatic malignant biliary obstruction(Safety for elderly patients)
Japan |
Malignant biliary obstruction
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate clinical efficacy of Covered WallFlex for unresectable extrahepatic malignant biliary obstruction, and clinical utility for elderly patients.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Stent patency period
Stent occlusion rate, Stent-related complication rate, Event free survival, overall survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Partialy Covered WallFlex biliary stent
20 | years-old | <= |
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 severely impaired organ
function
:Patients without written informed consent
:Patients considered ineligible for this
study.
40
1st name | |
Middle name | |
Last name | Toshio TSUYUGUCHI |
Chiba University Hospital
Department of Gastroenterology
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
1st name | |
Middle name | |
Last name | Yuji SAKAI |
Chiba University Hospital
Department of Gastroenterology
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
sakai4754@yahoo.co.jp
Chiba University Hospital
Chiba University Hospital
Self funding
NO
2010 | Year | 11 | Month | 01 | Day |
Partially published
Completed
2010 | Year | 02 | Month | 18 | Day |
2010 | Year | 04 | Month | 01 | Day |
2010 | Year | 10 | Month | 27 | Day |
2012 | Year | 05 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005335
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