UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022838 |
|---|---|
| Receipt number | R000026312 |
| Scientific Title | Study on the liver stiffness evaluated by shear wave elastography and Fibroscan for grading hepatic fibrosis and portal hypertension |
| Date of disclosure of the study information | 2016/06/22 |
| Last modified on | 2016/07/06 17:32:26 |
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Basic information
Public title
Study on the liver stiffness evaluated by shear wave elastography and Fibroscan for grading hepatic fibrosis and portal hypertension
Acronym
Elastography for grading fibrosis and portal hypertension
Scientific Title
Study on the liver stiffness evaluated by shear wave elastography and Fibroscan for grading hepatic fibrosis and portal hypertension
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Hitoshi MARUYAMA |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Gastroenterology and Nephrology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
+81-(0)43-226-2083
maru-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi MARUYAMA |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Gastroenterology and Nephrology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
+81-(0)43-226-2083
Homepage URL
maru-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
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)
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 | 06 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026312
