UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003050 |
|---|---|
| Receipt number | 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 10:34:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ykoizumi@m.ehime-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003690
