UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Outcomes of liver transplantation in infants younger than 1 year of age.
Title of the study (Brief title)	OLTI
Region	Japan

Condition
Condition	biliary atresia
Classification by specialty	Surgery in general Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will elucidate the intellectual development of patients who had living donor liver transplant in infancy.
Basic objectives2	Others
Basic objectives -Others	We will elucidate perioperative factors in living donor liver transplant affecting intellectual development.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Wechsler intelligence scale for children 4 at ages 5,710 and 15
Key secondary outcomes	Kyoto Scale of psychological development-2001 at ages 5, 7, 10, and 15

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	intelligence test in an outpatient in a day
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	5 years-old <=
Age-upper limit	17 years-old >=
Gender	Male and Female
Key inclusion criteria	Cases in which we underwent living donor liver transplant less than 1 year old and they continue regular follow-up at our hospital without problems for several years.
Key exclusion criteria	patients who never consent of intelligence test
Target sample size	26

Research contact person
Name of lead principal investigator	Taizo Hibi
Organization	Kumamoto University Hospital
Division name	Department of Transplantation and Pediatric Surgery
Address	1-1-1, Honjo, Chuo-ku, Kumamoto, 862-8556, Japan
TEL	096-373-5616
Email	hibi.taizo@kuh.kumamoto-u.ac.jp

Public contact
Name of contact person	Seiichi Kawabata
Organization	Kumamoto University Hospital
Division name	Department of Transplantation and Pediatric Surgery
Address	1-1-1, Honjo, Chuo-ku, Kumamoto, 862-8556, Japan
TEL	096-373-5616
Homepage URL
Email	5seiichi@kuh.kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University
Institute
Department

Funding Source
Organization	Kumamoto University
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

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 30 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 04 Month 30 Day
Anticipated trial start date	2018 Year 04 Month 30 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

Management information
Registered date	2018 Year 04 Month 20 Day
Last modified on	2018 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036863