UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026731 |
|---|---|
| Receipt number | R000030681 |
| Scientific Title | The safety and efficacy of laparoscopic liver resection for Child-Pugh B hepatocellular carcinoma |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2018/09/28 19:51:14 |
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Basic information
Public title
The safety and efficacy of laparoscopic liver resection for Child-Pugh B hepatocellular carcinoma
Acronym
The safety and efficacy of laparoscopic liver resection for Child-Pugh B hepatocellular carcinoma
Scientific Title
The safety and efficacy of laparoscopic liver resection for Child-Pugh B hepatocellular carcinoma
Scientific Title:Acronym
The safety and efficacy of laparoscopic liver resection for Child-Pugh B 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 evaluate the safety and efficacy of pure laparoscopic liver resection for Child-Pugh B HCC patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative short-term outcome.
Key secondary outcomes
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
Child-Pugh B HCC patients planned to undergo pure laparoscopic liver resection
Key exclusion criteria
none
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Seo |
Organization
Kyoto university hospital
Division name
Department of Surgery
Zip code
Address
54 Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3242
rutosa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Fuji |
Organization
Kyoto university hospital
Division name
Department of Surgery
Zip code
Address
54 Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3242
Homepage URL
fhiro@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/abs/10.1111/ases.12634
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
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design ; Cohort study
Study Patients; All patients who admitted in Kyoto university hospital and meet the selection criteria from 2004.
Management information
Registered date
| 2017 | Year | 03 | Month | 28 | Day |
Last modified on
| 2018 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030681
