UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053221 |
|---|---|
| Receipt number | R000060740 |
| Scientific Title | Surgical step recognition in laparoscopic distal gastrectomy using artificial intelligence. |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/12/25 23:22:41 |
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Basic information
Public title
Surgical step recognition in laparoscopic distal gastrectomy using artificial intelligence.
Acronym
Surgical step recognition in laparoscopic distal gastrectomy using artificial intelligence.
Scientific Title
Surgical step recognition in laparoscopic distal gastrectomy using artificial intelligence.
Scientific Title:Acronym
Surgical step recognition in laparoscopic distal gastrectomy using artificial intelligence.
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Artificial Intelligence (AI)-based recognition of surgical images has been used in the development of surgical assistive devices and image navigation systems. In this study, we developed an AI-based automatic recognition model of the surgical process of laparoscopic distal gastrectomy and evaluated its recognition performance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The accuracy of automatic step recognition model
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
Laparoscopic distal gastrectomy performed at the National Cancer Center East Hospital in 2019.
Key exclusion criteria
Without the surgery of laparoscopic distal gastrectomy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mitsumasa |
| Middle name | |
| Last name | Yoshida |
Organization
National Cancer Center Hospital East
Division name
Gastric Surgery Division
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
+81-4-7133-1111
mitsyosh@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Mitsumasa |
| Middle name | |
| Last name | Yoshida |
Organization
National Cancer Center Hospital East
Division name
Gastric Surgery Division
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
+81471331111
Homepage URL
mitsyosh@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital East
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
National Cancer Center Hospital East
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
Tel
+81471331111
mitsyosh@east.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
| 2024 | Year | 01 | Month | 01 | 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
40
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
| 2020 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We used 40 cases of laparoscopic distal gastrectomy performed at the National Cancer Center East Hospital in 2019. First, the surgical videos were classified into the following 9 ateps. Step 1: Ports insertion, Step 2: Lymphadenectomy on the left side of greater curvature, Step 3: Lymphadenectomy on the right side of greater curvature, Step 4: Division of duodenum, Step 5: Lymphadenectomy on the suprapancreatic lymph node, Step 6: Lymphadenectomy on the lesser curvature, Step 7: Division of stomach, Step 8: Reconstruction, Step 9: After reconstruction to completion of surgery. The accuracy of automatic step recognition was calculated using 30 surgical videos for training and 10 videos for validation.
Management information
Registered date
| 2023 | Year | 12 | Month | 25 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060740
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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