UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025732 |
|---|---|
| Receipt number | R000028324 |
| Scientific Title | Clinical trial about the evaluation of three-dimensional order-made liver model for the contribution to the surgical safety |
| Date of disclosure of the study information | 2017/01/18 |
| Last modified on | 2023/12/14 10:42:17 |
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Basic information
Public title
Clinical trial about the evaluation of three-dimensional order-made liver model for the contribution to the surgical safety
Acronym
3D-OliCS
Scientific Title
Clinical trial about the evaluation of three-dimensional order-made liver model for the contribution to the surgical safety
Scientific Title:Acronym
3D-OliCS
Region
| Japan |
Condition
Condition
disease of hepato-biliary-pancreatic surgery and transplantation
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
efficacy of liver model
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psycological stress of surgeon during operation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
use model during operation
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
typical liver resection category
- a case that is necessary to expose vessel or duct
high difficulty surgical technology category
- a surgery that is typocal but requires high difficulty surgical technology
- atypical liver transplantation
- other surgery of atypical and difficult case that liver model is expected to be usefull
Key exclusion criteria
- pre-opetative CT can not be obteined
- not enough time to make live model before operation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Uemoto |
Organization
Kyoto University
Graduate School of Medicine
Division name
Hepato-Biliary-Pancreatic surgery and Transplantation
Zip code
606-8507
Address
54 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3242
uemoto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Fukumitsu |
Organization
Kyoto University Hospital
Division name
Hepato-Biliary-Pancreatic surgery and Transplantation
Zip code
606-8507
Address
54 Kawahara-cho Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3242
Homepage URL
tsurugi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Kyoto University Hospital, Ethics Comitte
Address
Yoshida Konoe-cho, Shogoin, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 18 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
15
Results
confirmed the effectiveness of the custom-made liver model.
Results date posted
| 2020 | Year | 07 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 09 | Month | 25 | Day |
Baseline Characteristics
the patients in our department who receive particularly difficult liver surgery
Participant flow
entry after informed consent
Adverse events
none
Outcome measures
Subjective and objective evaluation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 18 | Day |
Last modified on
| 2023 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028324
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
