UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049909 |
|---|---|
| Receipt number | R000056845 |
| Scientific Title | Whole Liver Intraoperative Projection System Expanding into Laparoscopic Surgery |
| Date of disclosure of the study information | 2022/12/28 |
| Last modified on | 2022/12/28 15:34:45 |
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Basic information
Public title
Whole Liver Intraoperative Projection System Expanding into Laparoscopic Surgery
Acronym
Whole Liver Intraoperative Projection System Expanding into Laparoscopic Surgery
Scientific Title
Whole Liver Intraoperative Projection System Expanding into Laparoscopic Surgery
Scientific Title:Acronym
Whole Liver Intraoperative Projection System Expanding into Laparoscopic Surgery
Region
| Japan |
Condition
Condition
HBP diseases
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development of a laparoscopic liver navigation system that automatically superimposes a 3D image of the liver created by preoperative contrast CT and an image of the liver projected on the laparoscopy screen, using the contour of the liver as a feature point.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Using 150 of the 170 cases of information obtained, a software system will be created to superimpose liver 3D images on laparoscopically recorded videos of the actual liver by image processing. To verify the accuracy of the software system, we will demonstrate the superimposition of liver 3D images on 20 laparoscopic liver videos and evaluate the results with a questionnaire to about 10 surgeons in our department. The questionnaire will be used to evaluate (1) accuracy, (2) practicality, and (3) time required for superimposition, each on a 5-point scale.
Translated with www.DeepL.com/Translator (free version)
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for laparoscopic surgery and judged to require liver observation
Patients who have undergone 1mm-thick contrast-enhanced CT imaging
Key exclusion criteria
Cases of withdrawal of consent to participate
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Takamoto |
Organization
National Cancer Center Hospital, Japan
Division name
Division of hepatobiliary pancreatic surgery
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuou-ku, Tokyo, Japan
TEL
0334522511
ttakamot@ncc.go.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Takamoto |
Organization
National Cancer Center Hospital
Division name
Division of hepatobiliary pancreatic surgery
Zip code
1040045
Address
5-1-1, Tsukiji, Chuou-ku
TEL
0335422511
Homepage URL
ttakamot@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital, Japan
Institute
Department
Personal name
Funding Source
Organization
Fujifilm medical
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital
Address
5-1-1
Tel
0335422511
ttakamot@ncc.go.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
| 2022 | Year | 12 | Month | 28 | 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
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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2022 | Year | 12 | Month | 26 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056845
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
