UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	To evaluate the diagnostic accuracy of liver stiffness and spleen stiffness measured by MR Elastography in predicting esophageal varices
Title of the study (Brief title)	Evaluation of MR Elastography in predicting esophageal varices
Region	Japan Asia(except Japan)

Condition
Condition	Patients with chronic liver disease
Classification by specialty	Hepato-biliary-pancreatic medicine Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of liver stiffness and spleen stiffness measured by MR Elastography in predicting esophageal varices in patients with chronic liver disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate the diagnostic accuracy of liver stiffness and spleen stiffness measured by MR Elastography in predicting esophageal varices
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with chronic liver disease who are scheduled to treat or treated at our institute, provide a informed consent, and do not meet the below exclusion criteria.
Key exclusion criteria	1.Patients with history of interventional treatment for esophageal varices. 2.MRI examination is impossible (ex. Installation of pacemaker, claustrophobia). 3.In the opinion of the investigator, patient is unsuitable as a study subject.
Target sample size	200

Research contact person
Name of lead principal investigator	Atsushi Nakajima
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL	045-787-2640
Email	nakajima-tky@umin.ac.jp

Public contact
Name of contact person	Nobuaki Matsui
Organization	Yokohama City University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Kanagawa
TEL	045-787-2640
Homepage URL
Email	blastmatsui@gmail.com

Sponsor
Institute	Yokohama City University Graduate School 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	Yokohama City University Graduate School of Medicine, Department of Gastroenterology and Hepatology
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 04 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 25 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	This study is the cross-sectional method to assess the diagnostic accuracy of liver and spleen stiffness to find the esophageal varices in patients with chronic liver disease who visit our institution 1 Apr., 2016 to 31 Mar., 2017. Classifying into 3 categories, no, mild, severe depending on vatical grade and we measure 3 tesra MR-based liver and spleen stiffness(KPa) in each groups.

Management information
Registered date	2016 Year 04 Month 04 Day
Last modified on	2016 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025096