UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008658 |
|---|---|
| Receipt number | R000010164 |
| Scientific Title | Assessment of correlation among each measurement of liver fibrosis based on pathological diagnosis in resected specimen in chronic hepatitis and cirhhosis patients. |
| Date of disclosure of the study information | 2012/08/09 |
| Last modified on | 2012/08/09 13:43:54 |
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Basic information
Public title
Assessment of correlation among each measurement of liver fibrosis based on pathological diagnosis in resected specimen in chronic hepatitis and cirhhosis patients.
Acronym
Liverfibrosis Study
Scientific Title
Assessment of correlation among each measurement of liver fibrosis based on pathological diagnosis in resected specimen in chronic hepatitis and cirhhosis patients.
Scientific Title:Acronym
Liverfibrosis Study
Region
| Japan |
Condition
Condition
Liver disease to be resected
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of each measurement of liver fibrosis(RTE,ARFI,biological marker,liver biopsy)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation evaluation between each liver fibrosis measurement and quantified histological finding.
Key secondary outcomes
To evaluate the best combination of liver fibrosis measurement.
Correlation evaluation with intraoperative bleeding and RTE,ARFI
Correlation evaluation with incidence of postoperative complication and RTE,ARFI
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are scheduled to undergo hepatectomy or liver transplantation at our institution, provide a written informed consent at least 20 years or older.
Key exclusion criteria
Contraindication of this procedure.
Patient with insufficient specimen
Patients who are judged to have high risk in undergoing this trial.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Kokudo |
Organization
The University of Tokyo Hospital
Division name
Hepato-Billiary-Pancreatic Surgery Division,Artificial Organ and Transplantation Division
Zip code
Address
7-3-1 Hongo Bunkyo Tokyo
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Okinaga |
Organization
The University of Tokyo Hospital
Division name
Hepato-Billiary-Pancreatic Surgery Division,Artificial Organ and Transplantation Division
Zip code
Address
7-3-1 Hongo Bunkyo Tokyo
TEL
03-3815-5411
Homepage URL
YOSHINOH-SUR@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Hepato-Billiary-Pancreatic Surgery Division,The Artificial Organ and Transplantation Division,Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hitachi Aloka Medical
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 09 | 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
| 2011 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 30 | Day |
Other
Other related information
The correlation among RTE,ARFI,serum markers,liver biopsy based on pathological diagnosis in resected specimen.
Management information
Registered date
| 2012 | Year | 08 | Month | 09 | Day |
Last modified on
| 2012 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010164
