UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021765
Receipt No. R000025096
Scientific Title To evaluate the diagnostic accuracy of liver stiffness and spleen stiffness measured by MR Elastography in predicting esophageal varices
Date of disclosure of the study information 2016/04/04
Last modified on 2016/05/08

* 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 To evaluate the diagnostic accuracy of liver stiffness and spleen stiffness measured by MR Elastography in predicting esophageal varices
Acronym Evaluation of MR Elastography in predicting esophageal varices
Scientific Title To evaluate the diagnostic accuracy of liver stiffness and spleen stiffness measured by MR Elastography in predicting esophageal varices
Scientific Title:Acronym 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

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 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
1st name
Middle name
Last name Atsushi Nakajima
Organization Yokohama City University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
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
1st name
Middle name
Last name Nobuaki Matsui
Organization Yokohama City University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

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
2016 Year 02 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.