UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021765 |
|---|---|
| Receipt number | 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 00:54:06 |
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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
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
blastmatsui@gmail.com
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025096
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
