UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Liver Fibrosis in Patients with Chronic Liver Injury via Virtual Touch Tissue Quantification and Hepato-splenic Arterial Resistance
Title of the study (Brief title)	VTTQ-HepSAR Trial
Region	Japan

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

Objectives
Narrative objectives1	We examine the evaluation of liver fibrosis in patients with chronic liver injury via virtual touch tissue quantification and hepato-splenic arterial resistance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation of degree of the liver fibrosis with speed of the shear elastic wave by virtual touch tissue quantification and hepato-splenic arterial resistance.
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1.Patients with chronic liver injury or liver cirrhosis were histologically diagnosed by liver biopsy or liver specimen of resected liver. 2.We do not ask whether etiology of chronic liver injury or liver cirrhosis. 3.Patients received document agreement with participation in this study.
Key exclusion criteria	1.A pregnant woman and the patients with the pregnant possibility or the patients nursing a baby. 2.Contraindication of liver biopsy or liver resection. 3.splenectomy or PSE. 4. Patients who judged inappropriate by researcher.
Target sample size	500

Research contact person
Name of lead principal investigator	Youichi Morimoto and Yoshitaka Takuma
Organization	Kurashiki Central Hospital
Division name	Gastroenterology
Address	1-1-1,Miwa, Kurashiki, Okayama
TEL
Email

Public contact
Name of contact person	Rui Tamura
Organization	Kurashiki Central Hospital
Division name	Gastroenterology
Address
TEL
Homepage URL
Email	rt12966@kchnet.or.jp

Sponsor
Institute	Department of Gastroenterology, Kurashiki Central Hospital
Institute
Department

Funding Source
Organization	Kurashiki Central Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 10 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 06 Day
Anticipated trial start date	2010 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	1.Primary Endpoint We examine the evaluation of liver fibrosis in patients with chronic liver injury via virtual touch tissue quantification and hepato-splenic arterial resistance. 2.Secondary Endpoints We examine the evaluation of liver fibrosis in patients with chronic liver injury via virtual touch tissue quantification and serum non-invasive markers.

Management information
Registered date	2010 Year 10 Month 02 Day
Last modified on	2018 Year 10 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005150