UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the usefulness of non invasive liver function evaluation technology by ultrasound elastography
Title of the study (Brief title)	Study of the usefulness of non invasive liver function evaluation technology by ultrasound elastography
Region	Japan

Condition
Condition	Not limited
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop an algorithm for estimate fibrosis, inflammation and steatosis of the liver using Real-time Tissue Elastography (below RTE), Shear Wave Measurement (below SWM), and attenuation measurement, for liver disease patients undergoing liver biopsy or liver resection.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To develop an algorithm for estimate fibrosis, inflammation and steatosis of the liver
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	no gender restriction 20 years old more
Key exclusion criteria	Patients can not be measured by removing the ROI (region of interest Region of Interest) of elastography from tumor Pregnant women or the patient during breast-feeding.
Target sample size	450

Research contact person
Name of lead principal investigator	Masatoshi Kudo
Organization	Kinki university faculty of medicine
Division name	Department of gastroenterology and gepatology
Address	377-2, Ohnodai, Osaka-sayama, Osaka, Japan
TEL	072-366-0221
Email	yada@med.kindai.ac.jp

Public contact
Name of contact person	Norihisa Yada
Organization	Kinki university faculty of medicine
Division name	Department of gastroenterology and hepatology
Address	377-2, Ohnodai, Osaka-sayama, Osaka, Japan
TEL	073-366-0221
Homepage URL
Email	yada@med.kindai.ac.jp

Sponsor
Institute	Kinki university faculty of medicine, Department of gastroenterology and hepatology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Ehime university Musashino red cross 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	2016 Year 04 Month 27 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 07 Month 06 Day
Anticipated trial start date	2015 Year 07 Month 21 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	Unpublished
URL releasing results
Results
Other related information	no

Management information
Registered date	2016 Year 04 Month 27 Day
Last modified on	2016 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025470