UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041155 |
|---|---|
| Receipt number | R000047002 |
| Scientific Title | Short-term and long-term outcomes in living donors for liver transplantation |
| Date of disclosure of the study information | 2020/07/19 |
| Last modified on | 2021/07/20 22:20:22 |
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Basic information
Public title
Short-term and long-term outcomes in living donors for liver transplantation
Acronym
Short-term and long-term outcomes in living donors for liver transplantation
Scientific Title
Short-term and long-term outcomes in living donors for liver transplantation
Scientific Title:Acronym
Short-term and long-term outcomes in living donors for liver transplantation
Region
| Japan |
Condition
Condition
living donors for liver transplantation
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate short-term and long-term outcomes following donor hepatectomy
Basic objectives2
Others
Basic objectives -Others
na
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
short-term and long-term outcomes following donor hepatectomy
Key secondary outcomes
short-term outcomes according to the era and the graft type
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
living donors who underwent DH between 1996 and 2019
Key exclusion criteria
NONE
Target sample size
408
Research contact person
Name of lead principal investigator
| 1st name | Kosei |
| Middle name | |
| Last name | Takagi |
Organization
Okayama University Hospital
Division name
Department of Gastroenterological Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
+81-86-223-7151
kotakagi15@gmail.com
Public contact
Name of contact person
| 1st name | Kosei |
| Middle name | |
| Last name | Takagi |
Organization
Okayama University Hospital
Division name
Department of Gastroenterological Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
+81-86-223-7151
Homepage URL
kotakagi15@gmail.com
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
na
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
086-235-6938
mae6605@adm.okayama-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2006-011
Org. issuing International ID_1
2006-011
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
408
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
Main results already published
Date of protocol fixation
| 2020 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2020 | Year | 07 | Month | 19 | Day |
Last modified on
| 2021 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047002
