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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046702
Receipt No. 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 2022/01/23

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Basic information
Public title The feasibility of YABUSAME (uncovered self expandable metallic stent) for unresectable malignant hilar biliary obstruction: multicenter prospective observational study
Acronym YABUSAME study
Scientific Title The feasibility of YABUSAME (uncovered self expandable metallic stent) for unresectable malignant hilar biliary obstruction: multicenter prospective observational study
Scientific Title:Acronym YABUSAME study
Region
Japan

Condition
Condition unresectable malignant hilar biliary obstruction
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The clinical outcome of patients who had malignant hilar biliary obstruction and placed YABUSAME, uncovered self expandable metallic stent, will be investigated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the non-recurrence rate of biliary obstruction at 6 months
Key secondary outcomes 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

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Takuji
Middle name
Last name Okusaka
Organization Natioinal cancer center hospital
Division name department of hepatobiliary and pancreatic oncology
Zip code 1040045
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email tokusaka@ncc.go.jp

Public contact
Name of contact person
1st name Kotaro
Middle name
Last name Takeshita
Organization Natioinal cancer center hospital
Division name department of hepatobiliary and pancreatic oncology
Zip code 104-0045
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email ktakeshi@ncc.go.jp

Sponsor
Institute Natioinal cancer center hospital

department of hepatobiliary and pancreatic oncology
Institute
Department

Funding Source
Organization Natioinal cancer center hospital
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Natioinal cancer center hospital
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel 03-3542-2511
Email irst@ncc.go.jp

Secondary IDs
Secondary IDs YES
Study ID_1 2021-224
Org. issuing International ID_1 Natioinal cancer center hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2021 Year 11 Month 18 Day
Date of IRB
2021 Year 11 Month 18 Day
Anticipated trial start date
2021 Year 11 Month 18 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information multicenter prospective observational study

Management information
Registered date
2022 Year 01 Month 23 Day
Last modified on
2022 Year 01 Month 23 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053279

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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