Unique ID issued by UMIN | UMIN000046702 |
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Receipt number | R000053279 |
Scientific Title | The feasibility of YABUSAME (uncovered self expandable metallic stent) for unresectable malignant hilar biliary obstruction: multicenter prospective observational study |
Date of disclosure of the study information | 2022/01/24 |
Last modified on | 2023/01/24 09:10:06 |
The feasibility of YABUSAME (uncovered self expandable metallic stent) for unresectable malignant hilar biliary obstruction: multicenter prospective observational study
YABUSAME study
The feasibility of YABUSAME (uncovered self expandable metallic stent) for unresectable malignant hilar biliary obstruction: multicenter prospective observational study
YABUSAME study
Japan |
unresectable malignant hilar biliary obstruction
Hepato-biliary-pancreatic medicine |
Malignancy
NO
The clinical outcome of patients who had malignant hilar biliary obstruction and placed YABUSAME, uncovered self expandable metallic stent, will be investigated.
Efficacy
Confirmatory
Pragmatic
Not applicable
the non-recurrence rate of biliary obstruction at 6 months
technical success rate
clinical success rate
the non-recurrence rate of biliary obstruction at 3 months and 12 months
time to recurrence of biliary obstruction
overall survival time
adverse event
Observational
18 | years-old | <= |
Not applicable |
Male and Female
Patients with unresectable malignant hilar biliary obstruction who are judgeded the necessity of biliary drainage and planned to be placed YABUSAME.
Patients who are planned exchange the placed stent to YABUSAME.
P.S. (ECOG): 0, 1, 2
Age: 18 years or older
Written consent for participation in the study has been obtained from the patient.
Patients with unremovable SEMS at hilar portion who are planned additionally to be placed YABUSAME.
Patients who are planned to be placed YABUSAME via the EUS interventinal route.
Patients who do not have hilar obstruction.
45
1st name | Takuji |
Middle name | |
Last name | Okusaka |
Natioinal cancer center hospital
department of hepatobiliary and pancreatic oncology
1040045
5-1-1, Tsukiji, Chuo-ku, Tokyo
03-3542-2511
tokusaka@ncc.go.jp
1st name | Kotaro |
Middle name | |
Last name | Takeshita |
Natioinal cancer center hospital
department of hepatobiliary and pancreatic oncology
104-0045
5-1-1, Tsukiji, Chuo-ku, Tokyo
03-3542-2511
ktakeshi@ncc.go.jp
Natioinal cancer center hospital
department of hepatobiliary and pancreatic oncology
Natioinal cancer center hospital
Japanese Governmental office
Natioinal cancer center hospital
5-1-1, Tsukiji, Chuo-ku, Tokyo
03-3542-2511
irst@ncc.go.jp
YES
2021-224
Natioinal cancer center hospital
九州大学、埼玉医科大学総合医療センター、三重大学医学部附属病院、自治医大さいたま医療センター、大阪医科薬科大学、大阪国際がんセンター、筑波大学附属病院、帝京大学医学部附属溝口病院、北海道大学病院、国際医療福祉大学三田病院
2022 | Year | 01 | Month | 24 | Day |
Unpublished
45
No longer recruiting
2021 | Year | 11 | Month | 18 | Day |
2021 | Year | 11 | Month | 18 | Day |
2021 | Year | 11 | Month | 18 | Day |
2022 | Year | 12 | Month | 28 | Day |
2022 | Year | 12 | Month | 28 | Day |
2023 | Year | 12 | Month | 28 | Day |
2024 | Year | 03 | Month | 31 | Day |
multicenter prospective observational study
2022 | Year | 01 | Month | 23 | Day |
2023 | Year | 01 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053279
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