UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033123 |
|---|---|
| Receipt number | R000037771 |
| Scientific Title | Study for the correlation between liver fibrosis evaluated by using abdominal ultrasonography and prognosis in pediatric patients with liver diseases |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2018/06/23 19:05:36 |
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Basic information
Public title
Study for the correlation between liver fibrosis evaluated by using abdominal ultrasonography and prognosis in pediatric patients with liver diseases
Acronym
Study for the correlation between liver fibrosis evaluated by using abdominal ultrasonography and prognosis in pediatric patients with liver diseases
Scientific Title
Study for the correlation between liver fibrosis evaluated by using abdominal ultrasonography and prognosis in pediatric patients with liver diseases
Scientific Title:Acronym
Study for the correlation between liver fibrosis evaluated by using abdominal ultrasonography and prognosis in pediatric patients with liver diseases
Region
| Japan |
Condition
Condition
pediatric liver diseases
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of shear wave elastography(SWE) in children with liver diseases, by evaluating the relationshinp between stiffness, viscosity of the liver and spleen, and clinical data and course.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between liver and splenic hardness measured by SWE and autologous liver survival rate in patients with pediatric liver disease.
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
pediatric liver diseases
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Ishigami |
Organization
Nagoya University graduate school of medicine
Division name
department of gastroenterology and hepatology
Zip code
Address
65 Tsuruma cho Showa ku Nagoya Aichi
TEL
052-744-2169
masaishi@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Youji Ishizu |
Organization
Nagoya university hospital
Division name
department of gastroenterology and hepatology
Zip code
Address
65 Tsuruma cho Showa ku Nagoya Aichi
TEL
052-744-2169
Homepage URL
y-ishizu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University graduate school of medicine department of gastroenterology and hepatology
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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | 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
none
Management information
Registered date
| 2018 | Year | 06 | Month | 23 | Day |
Last modified on
| 2018 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037771
