UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022323
Receipt number 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 23:08:09

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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 or person

Institute

Ministry of Health, Labour and Welfare

Institute

Department

Personal name



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

Value
https://center6.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