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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014075
Receipt No. R000016383
Scientific Title Exploratory study of biomarker for complications as thrombosis after portal vein embolization
Date of disclosure of the study information 2014/06/01
Last modified on 2014/05/26

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Basic information
Public title Exploratory study of biomarker for complications as thrombosis after portal vein embolization
Acronym Exploratory study of biomarker for complications as thrombosis after portal vein embolization
Scientific Title Exploratory study of biomarker for complications as thrombosis after portal vein embolization
Scientific Title:Acronym Exploratory study of biomarker for complications as thrombosis after portal vein embolization
Region
Japan

Condition
Condition Patient underwent portal vein embolization
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Exploration of biomarker for complications as thrombosis in patient underwent portal vein embolization
Basic objectives2 Others
Basic objectives -Others To clarify diagnosis, treatment,
risk factor of complications as thrombosis in patient underwent portal vein embolization
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Exploration of biomarker for complications as thrombosis after portal vein embolization
Key secondary outcomes

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Hematologic test
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patient undergoing portal vein embolization
Key exclusion criteria No consent
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yu Sawada
Organization Yokohama City University Graduate School of Medicine
Division name Department of Gastoroenterological Surgery
Zip code
Address 3-9 Huku-ura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2650
Email t116036e@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yu Sawada
Organization Yokohama City University Graduate School of Medicine
Division name Department of Gastoroenterological Surgery
Zip code
Address 3-9 Huku-ura, Kanazawa-ku, Yokohama, Japan
TEL 045-787-2650
Homepage URL
Email t116036e@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 01 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 Preinitiation
Date of protocol fixation
2014 Year 05 Month 09 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 05 Month 26 Day
Last modified on
2014 Year 05 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016383

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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