UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the liver stiffness evaluated by shear wave elastography and Fibroscan for grading hepatic fibrosis and portal hypertension
Title of the study (Brief title)	Elastography for grading fibrosis and portal hypertension
Region	Japan

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

Objectives
Narrative objectives1	To examine the diagnostic ability of two-dimensional shear wave elastography (2D-SWE) with propagation-based reliability for grading of hepatic fibrosis and portal hypertension
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic ability of 2D-SWE for cirrhosis
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	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Shear wave elastography in the right hepatic lobe using the abdominal ultrasound apparatus (for patients with chronic hepatitis or liver cirrhosis) Live biopsy (for patients with chronic hepatitis or liver cirrhosis) Measurement of hepatic vein pressure (for patients with liver cirrhosis and esophageal/gastric varices)
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	Patients with chronic hepatitis or liver cirrhosis in our hospital Patients whose document consent was obtained under their free will and understandings, after receiving sufficient explanation on the medical condition and treatment Patients who are able to be followed up in our hospital
Key exclusion criteria	Patients with thrombosis in portal vein, splenic vein, and/or the superior mesenteric vein Patients with liver tumors Patients who have diseases causing the abnormality in the number of platelets other than liver cirrhosis Patients with idiopathic portal hypertension or extrahepatic portal obstruction Patients with severe heart disease or lung disease Pregnant patients Patients whom the doctors have determined to be inappropriate
Target sample size	150

Research contact person
Name of lead principal investigator	Hitoshi MARUYAMA
Organization	Chiba University Graduate School of Medicine
Division name	Department of Gastroenterology and Nephrology
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	+81-(0)43-226-2083
Email	maru-cib@umin.ac.jp

Public contact
Name of contact person	Hitoshi MARUYAMA
Organization	Chiba University Graduate School of Medicine
Division name	Department of Gastroenterology and Nephrology
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL	+81-(0)43-226-2083
Homepage URL
Email	maru-cib@umin.ac.jp

Sponsor
Institute	Chiba University
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	None
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 06 Month 22 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 22 Day
Last modified on	2016 Year 07 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026312