UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005954 |
|---|---|
| Receipt number | R000007038 |
| Scientific Title | The evaluation of the usefulness of the liver stiffness measurement by elastography in the childhood liver disease |
| Date of disclosure of the study information | 2011/07/09 |
| Last modified on | 2013/05/09 16:24:33 |
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Basic information
Public title
The evaluation of the usefulness of the liver stiffness measurement by elastography in the childhood liver disease
Acronym
The evaluation of the usefulness of the liver stiffness measurement by elastography in the childhood liver disease
Scientific Title
The evaluation of the usefulness of the liver stiffness measurement by elastography in the childhood liver disease
Scientific Title:Acronym
The evaluation of the usefulness of the liver stiffness measurement by elastography in the childhood liver disease
Region
| Japan |
Condition
Condition
biliary atresia
post-liver transplantation
other liver disease
healthy child
Classification by specialty
| Hepato-biliary-pancreatic surgery | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the usefulness of the liver stiffness measurement by elastography in the childhood liver disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Liver stiffness measurement by ARFI elastography (Vs)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
ultrasound examination
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
1) The patients who undergo percutaneous liver biopsy because of chronic liver disease in our department.
2) The patients who undergo laparotomy liver biopsy because of some kind of disease.
3) The patients who undergo whole liver resection for liver transplantation.
4) The children who undergo the operation of the inguinal hernia and the similar disease in our hospital without underlying disease.
5) Written informed consent.
Key exclusion criteria
The patients who was not obtained written informed consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fuchimoto Yasushi |
Organization
Keio University School of Medicine
Division name
Department of Pediatric Surgery
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomita Hirofumi |
Organization
Keio University School of Medicine
Division name
Department of Pediatric Surgery
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
Homepage URL
htomita@a3.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2011 | Year | 07 | Month | 09 | 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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 09 | Day |
Last modified on
| 2013 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007038
