UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015387 |
|---|---|
| Receipt number | R000017751 |
| Scientific Title | Analysis of liver fibrosis for chronic liver disease by the microbubble contrast agents |
| Date of disclosure of the study information | 2014/10/10 |
| Last modified on | 2014/10/09 17:58:18 |
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Basic information
Public title
Analysis of liver fibrosis for chronic liver disease by the microbubble contrast agents
Acronym
Assessment of liver fibrosis by the microbubble agents
Scientific Title
Analysis of liver fibrosis for chronic liver disease by the microbubble contrast agents
Scientific Title:Acronym
Assessment of liver fibrosis by the microbubble agents
Region
| Japan |
Condition
Condition
Chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare quantitative parameters of contrast-enhanced ultrasonography with fibrosis stages of liver specimens
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare fibrosis stages of liver specimens with contrast parameters which were the ratio between portal vein and liver parenchyma, and the time interval from the onset of contrast enhancement in portal vein to the time of the maximum intensity ratio
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
| Medicine |
Interventions/Control_1
Microbubble contrast agents; Sonazoid
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with chronic hepatitis or cirrhosis who were planned to receive liver biopsy (percutaneous or transvenous)
2. Having received adequate explanation of the contents of the trial and given their written consent
Key exclusion criteria
1. Egg allergy
2. Severe lung disease
3. Severe heart disease
4. Determined to be ineligible by the physician in charge for any other reason
Target sample size
120
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, Chuou-ku, Chiba, Japan
TEL
043-226-2083
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, Chuou-ku, Chiba, Japan
TEL
043-226-2083
Homepage URL
maru-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine, Department of Gastroenterology and Nephrology
Institute
Department
Personal name
Funding Source
Organization
Chiba University Graduate School of Medicine, Department of Gastroenterology and Nephrology
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 10 | Month | 10 | 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
| 2007 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | 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
| 2014 | Year | 10 | Month | 09 | Day |
Last modified on
| 2014 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017751
