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

Email



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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name