UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032326 |
|---|---|
| Receipt number | R000036863 |
| Scientific Title | Outcomes of liver transplantation in infants younger than 1 year of age. |
| Date of disclosure of the study information | 2018/04/30 |
| Last modified on | 2018/04/20 10:50:16 |
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Basic information
Public title
Outcomes of liver transplantation in infants younger than 1 year of age.
Acronym
OLTI
Scientific Title
Outcomes of liver transplantation in infants younger than 1 year of age.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Taizo Hibi |
Organization
Kumamoto University Hospital
Division name
Department of Transplantation and Pediatric Surgery
Zip code
Address
1-1-1, Honjo, Chuo-ku, Kumamoto, 862-8556, Japan
TEL
096-373-5616
hibi.taizo@kuh.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiichi Kawabata |
Organization
Kumamoto University Hospital
Division name
Department of Transplantation and Pediatric Surgery
Zip code
Address
1-1-1, Honjo, Chuo-ku, Kumamoto, 862-8556, Japan
TEL
096-373-5616
Homepage URL
5seiichi@kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
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)
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
| 2018 | Year | 04 | Month | 30 | 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 | 04 | Month | 30 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036863
