UMIN-CTR Clinical Trial

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
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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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