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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010676
Receipt No. R000012484
Scientific Title Evaluation of utility of liver and spleen stiffness measurement by acoustic radiation force impulse (ARFI) imaging in long-term follow-up for pediatric liver disease
Date of disclosure of the study information 2013/05/09
Last modified on 2013/05/09

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Basic information
Public title Evaluation of utility of liver and spleen stiffness measurement by acoustic radiation force impulse (ARFI) imaging in long-term follow-up for pediatric liver disease
Acronym Liver and spleen stiffness measurement for pediatric liver disease
Scientific Title Evaluation of utility of liver and spleen stiffness measurement by acoustic radiation force impulse (ARFI) imaging in long-term follow-up for pediatric liver disease
Scientific Title:Acronym Liver and spleen stiffness measurement for pediatric liver disease
Region
Japan

Condition
Condition Pediatric liver disease
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Pediatrics
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the reproducibility and variability of liver and spleen stiffness measurement by ARFI imaging.
To develop an algorithm for the evaluation in follow-up of pediatric liver disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Liver and spleen stiffness measurement by ARFI imaging.
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 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 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) Subjects who are followed up for pediatric liver disease.
2) Subjects who give a written informed consent.
Key exclusion criteria 1) Subjects who have hepatitis B or C.
2) Subjects who do not give a written informed consent.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Hoshino
Organization Keio University School of Medicine
Division name Department of Pediatric Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hirofumi Tomita
Organization Keio University School of Medicine
Division name Department of Pediatric Surgery
Zip code
Address
TEL
Homepage URL
Email htomita@a3.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
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
2013 Year 05 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 Enrolling by invitation
Date of protocol fixation
2013 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 09 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
2013 Year 05 Month 08 Day
Last modified on
2013 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012484

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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