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
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
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
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 |
Single case data URL
Value
https://center6.umin.ac.jp/ice/25642
