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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003050
Receipt No. R000003690
Scientific Title Noninvasive diagnosis of liver fibrosis by real-time tissue elastography: Establishment of the method for measurement
Date of disclosure of the study information 2010/01/17
Last modified on 2014/03/04

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Basic information
Public title Noninvasive diagnosis of liver fibrosis by real-time tissue elastography: Establishment of the method for measurement
Acronym Diagnosis of liver fibrosis by Real-time Tissue Elastography (RTE)
Scientific Title Noninvasive diagnosis of liver fibrosis by real-time tissue elastography: Establishment of the method for measurement
Scientific Title:Acronym Diagnosis of liver fibrosis by Real-time Tissue Elastography (RTE)
Region
Japan

Condition
Condition Chronic liver injury
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this prospective study was to establish how to obtain an accurate value of liver stiffness using Real-time Tissue Elastography, and to validate that Real-time Tissue Elastography is useful by comparing it with transient elastography and other conventional calculated indices of liver fibrosis based on blood parameters. Moreover, this study examined whether there were differences that depended on the measurement site and between observers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Diagnosis of liver fibrosis by Real-time Tissue Elastography.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Written agreement of participation for this study could be obtained.
2) Subjects who can be done the measurement by abdominal ultrasound.
3) Patients who could be received the histological evaluation by laparoscopic liver biopsy or percutaneous liver biopsy.
Key exclusion criteria 1) Written agreement of participation for this study could not be obtained.
2) Subjects who cannot be done the measurement by abdominal ultrasound.
3) A case with ascites.
4) The subjects who were estimated that it is inappropriate to participate the study by the responsible physician.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Hiasa
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code
Address Shitsukawa, Toon, Ehime 791-0295, Japan
TEL +81-89-960-5308
Email ykoizumi@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yohei Koizumi
Organization Ehime University Graduate School of Medicine
Division name Department of Gastroenterology and Metabology
Zip code
Address Shitsukawa, Toon, Ehime 791-0295, Japan
TEL +81-89-960-5308
Homepage URL
Email ykoizumi@m.ehime-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 17 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2009 Year 11 Month 24 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2014 Year 09 Month 01 Day
Date of closure to data entry
2015 Year 09 Month 01 Day
Date trial data considered complete
2015 Year 09 Month 01 Day
Date analysis concluded
2015 Year 09 Month 01 Day

Other
Other related information The patients who participate in this study will be received blood biochemical examination, hepatic histological evaluation, the measurement
of hepatic venous pressure gradient by catheterization of the hepatic veins and the examination of Real-time Tissue Elastography by abdominal ultrasound. We analyze those data, and evaluate the accuracy of the diagnosis for liver fibrosis by Real-time Tissue Elastography to other procedures.
This is a prospective study, and we do random sampling.

Management information
Registered date
2010 Year 01 Month 17 Day
Last modified on
2014 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003690

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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