UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050002 |
|---|---|
| Receipt number | R000056949 |
| Scientific Title | the multi-instituitional analitycal retrospective cohort study for predictive operative risk factor ans short period survival in hepatocellular carcinoma patients undergoing central bisectionectomy |
| Date of disclosure of the study information | 2023/12/28 |
| Last modified on | 2023/01/10 16:35:28 |
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Basic information
Public title
the multi-instituitional analitycal retrospective cohort study for predictive operative risk factor ans short period survival in hepatocellular carcinoma patients undergoing central bisectionectomy
Acronym
Operative risk analysis by retrospective cohort in central bisectionectomy in hepatocellualra carcinoma
Scientific Title
the multi-instituitional analitycal retrospective cohort study for predictive operative risk factor ans short period survival in hepatocellular carcinoma patients undergoing central bisectionectomy
Scientific Title:Acronym
KSGLS study for CB
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma centrally located in the liver
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clarifying operative risk factros for severe complications and its limit of up-front surgery in central bisectionectomy for advanced hepatocellular carcinoma
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
critical adverse events
Key secondary outcomes
surgical records: blood loss operating time
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Optimal indication of central bisectinectomy, or sufficient data collection
Key exclusion criteria
Inadequate indication of HCC for central sisectionetomy by the tumor factor, many data loss
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Nanashima |
Organization
university of Miyazaki
Division name
Department of Surgery
Zip code
8891692
Address
5200 kihara kiyotake miyazaki-shi
TEL
0985852905
a_nanashima@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Nanashima |
Organization
university of miyazaki
Division name
Department of Surgery
Zip code
889-1692
Address
5200 Kihara kiyotake miyazaki
TEL
0985852905
Homepage URL
ananasm7@gmail.com
Sponsor or person
Institute
university of miyazaki
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Ethical center of University of Miyazaki
Address
5200kihara
Tel
0985852905
a_nanashima@med.miyazaki-u.ac.jp
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
| 2023 | Year | 12 | Month | 28 | 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
171
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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 01 | Month | 10 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056949
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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