UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for the correlation between liver fibrosis evaluated by using abdominal ultrasonography and prognosis in pediatric patients with liver diseases
Title of the study (Brief title)	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	Masatoshi Ishigami
Organization	Nagoya University graduate school of medicine
Division name	department of gastroenterology and hepatology
Address	65 Tsuruma cho Showa ku Nagoya Aichi
TEL	052-744-2169
Email	masaishi@med.nagoya-u.ac.jp

Public contact
Name of contact person	Youji Ishizu
Organization	Nagoya university hospital
Division name	department of gastroenterology and hepatology
Address	65 Tsuruma cho Showa ku Nagoya Aichi
TEL	052-744-2169
Homepage URL
Email	y-ishizu@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University graduate school of medicine department of gastroenterology and hepatology
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 06 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037771