UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051541 |
|---|---|
| Receipt number | R000058808 |
| Scientific Title | Automatic Liver Vessel Recognition for Laparoscopic Liver resection using Artificial Intelligence |
| Date of disclosure of the study information | 2023/07/07 |
| Last modified on | 2023/07/07 10:36:17 |
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Basic information
Public title
Automatic Liver Vessel Recognition for Laparoscopic Liver resection using Artificial Intelligence
Acronym
AI For Laparoscopic Hepatectomy
Scientific Title
Automatic Liver Vessel Recognition for Laparoscopic Liver resection using Artificial Intelligence
Scientific Title:Acronym
AI For Laparoscopic Hepatectomy
Region
| Japan |
Condition
Condition
Hepatocellular Carcinoma
Metastatic Cancer Of The Liver
Intrahepatic Cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop novel intraoperative navigation systems of computer-assisted surgery for laparoscopic hepatectomy.
Basic objectives2
Others
Basic objectives -Others
To develop a deep-learning model for automated liver vessel recognition in laparoscopic liver resection.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The evaluation metrics for the models were the Dice coefficient for quantitative assessment, and the rubric-based assessment by ten gastroenterological surgeons for qualitative assessment.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
We constructed a dataset containing 53 cases of laparoscopic partial liver resection, all of which were performed by four surgeons at the National Cancer Center Hospital East (NCCHE) in Kashiwa, Japan, between July 2018 and January 2020.
Key exclusion criteria
Patients with partial liver resection of segment 1 and no vessels requiring clipping during liver parenchymal transection.
Target sample size
53
Research contact person
Name of lead principal investigator
| 1st name | Masaaki |
| Middle name | |
| Last name | Ito |
Organization
National Cancer Center Hospital East
Division name
Division of Medical Device Innovation
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa-City, Chiba 277-8577, Japan
TEL
0471-33-1111
maito@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Ito |
Organization
National Cancer Center Hospital East
Division name
Division of Medical Device Innovation
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa-City, Chiba 277-8577, Japan
TEL
0471-33-1111
Homepage URL
maito@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
non
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
Institutional Review Board, National Cancer Center Hospital East
Address
6-5-1, Kashiwanoha, Kashiwa-City, Chiba 277-8577, Japan
Tel
0471-33-1111
irst@ml.res.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
| 2023 | Year | 07 | Month | 07 | 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
53
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
Main results already published
Date of protocol fixation
| 2020 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Project No. 2020-315
Title: Analytical research on surgical information using a database of surgical videos of endoscopic surgeries
Management information
Registered date
| 2023 | Year | 07 | Month | 07 | Day |
Last modified on
| 2023 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058808
