UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045821 |
|---|---|
| Receipt number | R000052308 |
| Scientific Title | A retrospective study of the outcome of hepatocellular carcinoma after liver resection |
| Date of disclosure of the study information | 2021/10/21 |
| Last modified on | 2021/10/21 17:16:17 |
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Basic information
Public title
A retrospective study of the outcome of hepatocellular carcinoma after liver resection
Acronym
A retrospective study of the outcome of hepatocellular carcinoma after liver resection
Scientific Title
A retrospective study of the outcome of hepatocellular carcinoma after liver resection
Scientific Title:Acronym
A retrospective study of the outcome of hepatocellular carcinoma after liver resection
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the therapeutic efficacy of hepatic resection for hepatocellular carcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Recurrence site of hepatocellular carcinoma
Key secondary outcomes
Recurrence-free survival, overall survival, Preoperative factor, operative factor
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent liver resection for initial hepatocellular carcinoma at Nara Medical University
Key exclusion criteria
Death by other diseases within 5 years
Target sample size
278
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Hokuto |
Organization
Nara Medical University
Division name
Surgery
Zip code
634-8522
Address
840 shijyocho Kashihar Nara Japan
TEL
0744223051
hokuto@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Hokuto |
Organization
Nara Medical University
Division name
Surgery
Zip code
634-8522
Address
840 shijyocho Kashihara Nara Japan
TEL
0744223051
Homepage URL
hokuto@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical 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
IRB of Nara Medical University
Address
840 shijyocho Kashihara Nara Japan
Tel
0744223051
hokuto@naramed-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
| 2021 | Year | 10 | Month | 21 | 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
278
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
| 2019 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
278 patients with primary HCC who underwent curative liver resection between 2000 and 2016 at Nara Medical University Hospital were retrospectively reviewed.
Management information
Registered date
| 2021 | Year | 10 | Month | 21 | Day |
Last modified on
| 2021 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052308
