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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031491
Receipt No. R000035951
Scientific Title Comparison of diagnostic accuracy for liver fibrosis between ultrasound elastography and MR elastography
Date of disclosure of the study information 2018/03/01
Last modified on 2018/04/18

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Basic information
Public title Comparison of diagnostic accuracy for liver fibrosis between ultrasound elastography and MR elastography
Acronym Comparison between ultrasound elastography and MR elastography
Scientific Title Comparison of diagnostic accuracy for liver fibrosis between ultrasound elastography and MR elastography
Scientific Title:Acronym Comparison between ultrasound elastography and MR elastography
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the diagnostic accuracy for liver
fibrosis in patients with chronic liver diseases by using US elastography and MR elastography
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the diagnostic accuracy for liver
fibrosis in patients with chronic liver diseases by using US elastography and MR elastography
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients who are scheduled to undergo liver biopsy or hepatectomy at our institution, provide a written informed consent, and do not meet the below exclusion criteria.
Key exclusion criteria 1. Patients with anti-coagulation therapy
2. MRI examination is impossible (ex. Installation of pacemaker, claustrophobia)
3. Pregnant patients
4. 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 Kento Imajo
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 kento318@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kento Imajo
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 kento318@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University Graduate School of Medicine
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
2018 Year 03 Month 01 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
2018 Year 02 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study

Management information
Registered date
2018 Year 02 Month 26 Day
Last modified on
2018 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035951

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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