UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020578 |
|---|---|
| Receipt number | R000023600 |
| Scientific Title | Health-Related Quality of Life (HRQOL) in recipients and donors after living donor liver transplantation |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2016/02/19 10:30:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Health-Related Quality of Life (HRQOL) in recipients and donors after living donor liver transplantation
Acronym
HRQOL after living donor liver transplantation
Scientific Title
Health-Related Quality of Life (HRQOL) in recipients and donors after living donor liver transplantation
Scientific Title:Acronym
HRQOL after living donor liver transplantation
Region
| Japan |
Condition
Condition
Liver diseease(recipient) / Healthy person(donor)
Classification by specialty
| Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the Health-Related Quality of Life (HRQOL) in recipients and donors after living donor liver transplantation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Health-Related Quality of Life (HRQOL) (pre operation, 1 year after, 2 year after,3 year after)
Key secondary outcomes
Temperament and Character Inventory-125(TCI-125), Parental Bonding Instrument(PBI), Hospital Anxiety and Depression(HAD) Scale, Visual Analog Scale(VAS), Social Support Questionnaire(SSQ),Brief Evaluation of Medication Influence and Beliefs(BEMIB), Alcohol Use Disorder Identification Test(AUDIT), Structured Clinical Interview for DSM-IV (SCID)(pre operation, 1 year after, 2 year after,3 year after)
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
liver transplant candidates(recipient/donor)
Key exclusion criteria
Informed consent can be obtained.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ozaki Norio |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
65 Tsurumai, Showa, Nagoya, Aichi, Japan
TEL
052-744-2282
ozaki-n@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimura Hiroyuki |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
65 Tsurumai, Showa, Nagoya, Aichi, Japan
TEL
052-744-2282
Homepage URL
kimurahi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Psychiatry, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization
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
| 2016 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2011 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Based on case-control and longitudinal model. We recruit a liver transplant candidate(recipient/donor) who undergo liver transplantation at Nagoya University Hospital from March 18, 2011.
Management information
Registered date
| 2016 | Year | 01 | Month | 15 | Day |
Last modified on
| 2016 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023600
