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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022323
Receipt No. R000025642
Scientific Title Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease (FIBROELAST-III Study)
Date of disclosure of the study information 2018/05/16
Last modified on 2019/05/27

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Basic information
Public title Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease (FIBROELAST-III Study)
Acronym Assessment of liver fibrosis by MRE
Scientific Title Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease (FIBROELAST-III Study)
Scientific Title:Acronym Assessment of liver fibrosis by MRE
Region
Japan

Condition
Condition liver tumor
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Assessment of liver fibrosis and blood loss during liver resection
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Association of liver stiffnes measurement with liver fibrosis and blood loss during liver resection
Key secondary outcomes

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
20 years-old <=
Age-upper limit
95 years-old >=
Gender Male and Female
Key inclusion criteria over 20 years of age, candidates for liver resection for liver cancer, and provided written, informed consent.
Key exclusion criteria contraindications to magnetic resonance imaging and those who were pregnant or trying to become pregnant. Patients with clinical or biochemical evidence of decompensated liver function with Child-Pugh score C, ICGR15 over 35%, total bilirubin over 2.0, hepatic encephalopathy, or significant systemic disease
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Tadatoshi
Middle name
Last name Takayama
Organization Nihon University
Division name Digestive Surgery
Zip code 173-8610
Address 30-1 Ouaguchikami-machi, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Email takayama.tadatoshi@nihon-u.ac.jp

Public contact
Name of contact person
1st name Yutaka
Middle name
Last name Midorikawa
Organization Nihon University
Division name Digestive Surgery
Zip code 173-8610
Address 30-1 Ouaguchikami-machi, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Homepage URL
Email mido-tky@umin.ac.p

Sponsor
Institute Ministry of Health, Labour and Welfare
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
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 Nihon Univ. School of Med.
Address 30-1 Oyaguchi-Kamimachi Itabashi-Ku
Tel 03-3972-8111
Email hirai.takamasa@nihon-u.ac.jp

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
2018 Year 05 Month 16 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 Open public recruiting
Date of protocol fixation
2014 Year 01 Month 07 Day
Date of IRB
2014 Year 12 Month 19 Day
Anticipated trial start date
2014 Year 12 Month 20 Day
Last follow-up date
2019 Year 05 Month 31 Day
Date of closure to data entry
2019 Year 05 Month 31 Day
Date trial data considered complete
Date analysis concluded
2024 Year 05 Month 31 Day

Other
Other related information In addition to liver fibrosis, measurement of blood loss during hepatectomy.

Management information
Registered date
2016 Year 05 Month 16 Day
Last modified on
2019 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025642

Research Plan
Registered date File name
2016/11/15 elasgorhaphy.docx

Research case data specifications
Registered date File name
2016/11/15 elasgorhaphy_2.docx

Research case data
Registered date File name
2016/11/15 elasgorhaphy_3.docx


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