UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041749 |
|---|---|
| Receipt number | R000047654 |
| Scientific Title | Influence of renal dysfunction on the outcomes of hepatectomy for hepatocellular carcinoma |
| Date of disclosure of the study information | 2020/09/11 |
| Last modified on | 2020/09/10 19:22:32 |
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Basic information
Public title
Influence of renal dysfunction on the outcomes of hepatectomy for hepatocellular carcinoma
Acronym
Influence of renal dysfunction on the outcomes of hepatectomy for hepatocellular carcinoma
Scientific Title
Influence of renal dysfunction on the outcomes of hepatectomy for hepatocellular carcinoma
Scientific Title:Acronym
Influence of renal dysfunction on the outcomes of hepatectomy for hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the influence of renal dysfunction on postoperative outcomes in patients with hepatocellular carcinoma.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Development of postoperative complications
Key secondary outcomes
Overall survival
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
Initial and radical hepatectomy for heptaic tumor.
Diagnosed histologically as hepatocellular carcinoma.
Key exclusion criteria
End-stage kidney disease receiving hemodialysis.
Malignancies except hepatocellular carcinoma.
Target sample size
238
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Kobayashi |
Organization
Hiroshima University
Division name
Department of Gastroenterological and Transplant Surgery
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN
TEL
082-257-5222
tsukoba@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Naruhiko |
| Middle name | |
| Last name | Honmyo |
Organization
Hiroshima University
Division name
Department of Gastroenterological and Transplant Surgery
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, JAPAN
TEL
082-257-5222
Homepage URL
naruhiko.honmyo@gmail.com
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, JAPAN
Tel
082-257-5222
naruhiko.honmyo@gmail.com
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
| 2020 | Year | 09 | Month | 11 | 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
238
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
| 2018 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The observation period has ended.
Management information
Registered date
| 2020 | Year | 09 | Month | 10 | Day |
Last modified on
| 2020 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047654
