UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036629 |
|---|---|
| Receipt number | R000030755 |
| Scientific Title | Preoperative simulation for hepatectomy by Resection Process Map |
| Date of disclosure of the study information | 2019/04/30 |
| Last modified on | 2019/04/30 13:35:17 |
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Basic information
Public title
Preoperative simulation for hepatectomy by Resection Process Map
Acronym
Preoperative simulation for hepatectomy by Resection Process Map
Scientific Title
Preoperative simulation for hepatectomy by Resection Process Map
Scientific Title:Acronym
Preoperative simulation for hepatectomy by Resection Process Map
Region
| Japan |
Condition
Condition
Hepatectomy
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the validity of simulation software "Resection Process Map"
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The similarity of resection surface between preoperative simulation and intra-operative images
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo planned hepatectomy in Kyoto university hospital during study period are included.
Key exclusion criteria
Patients without necessary preoperative imaging studies and patients who are scheduled to undergo hepatectomy which is unsuitable for preoperative simulation(e.g. small resection) are excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Taura |
| Middle name | |
| Last name | Kojiro |
Organization
Kyoto university hospital
Division name
Department of surgery, division of hepatobiliary pancreatic surgery and transplantation
Zip code
606-8507
Address
54, shogoinkawaharacho, sakyo-ku, Kyoto
TEL
075-751-3242
ktaura@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Taura |
| Middle name | |
| Last name | Kojiro |
Organization
Kyoto university hospital
Division name
Department of surgery, division of hepatobiliary pancreatic surgery and transplantation
Zip code
606-8507
Address
Syougoinkawaramachi 54, Sakyo-ku, Kyoto
TEL
075-751-4323
Homepage URL
ktaura@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of surgery, division of hepatobiliary pancreatic surgery and transplantation, Kyoto university hospital
Institute
Department
Personal name
Funding Source
Organization
This study is not funded.
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
Kyoto University Hospital, Division of general coordination
Address
54, shogoinkawaharacho, sakyo-ku, Kyoto
Tel
075-751-4899
trans@kuhp.kyoto-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
| 2019 | Year | 04 | Month | 30 | 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
24
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
| 2017 | Year | 01 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
24 patients were enrolled and the study was closed.
Management information
Registered date
| 2019 | Year | 04 | Month | 30 | Day |
Last modified on
| 2019 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030755
