UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052901 |
|---|---|
| Receipt number | R000060352 |
| Scientific Title | Study on the Improvement Effects of Landmark Recognition during Laparoscopic Gastrectomy Using the Intraoperative Landmark Indication System (Version 2.5) by Artificial Intelligence |
| Date of disclosure of the study information | 2024/01/20 |
| Last modified on | 2023/11/25 12:55:20 |
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Basic information
Public title
Study on the Improvement Effects of Landmark Recognition during Laparoscopic Gastrectomy Using the Intraoperative Landmark Indication System (Version 2.5) by Artificial Intelligence
Acronym
Study on the Improvement Effects of Landmark Recognition during Laparoscopic Gastrectomy Using the Intraoperative Landmark Indication System (Version 2.5) by Artificial Intelligence
Scientific Title
Study on the Improvement Effects of Landmark Recognition during Laparoscopic Gastrectomy Using the Intraoperative Landmark Indication System (Version 2.5) by Artificial Intelligence
Scientific Title:Acronym
Study on the Improvement Effects of Landmark Recognition during Laparoscopic Gastrectomy Using the Intraoperative Landmark Indication System (Version 2.5) by Artificial Intelligence
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the educational effectiveness of our developed improved artificial intelligence system (Version 2.5) as an intraoperative Landmark Indication System in enhancing the surgical skills of surgeons
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concordance and change rates in anatomical landmark recognition before and after AI system Indication among a grouped target population (surgeons)
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
1) Diagnosed histologically as gastric cancer (pap, tub1, tub2, por1, por2, sig, muc) through endoscopic biopsy from the primary gastric lesion.
2) Diagnosed as Stage I-III through endoscopic examination and contrast-enhanced CT of the upper abdomen and pelvis (slice thickness of 1cm or less; plain CT is acceptable in cases of contrast agent allergy).
3) The site of tumor involvement and presence of multiple tumors are not criteria for exclusion.
4)Performance Status (ECOG) is 0 or 1.
5)Major organ functions are preserved.
Surgical videos of laparoscopic gastrectomy performed at our institution, meeting the above criteria 1)-5), will be used."
Key exclusion criteria
1) Cases with a BMI of 30 or above.
2) Cases with bulky lymph node metastasis.
Surgical videos of laparoscopic gastrectomies performed at our institution that meet the above criteria 1) and 2) will be excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Inomata |
Organization
Oita University Faculty of Medicine
Division name
Gastroenterological and Pediatric Surgery
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama-machi, Yufu city, Oita
TEL
097-586-5843
oitagps@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Hasegawa |
Organization
Oita University Faculty of Medicine
Division name
Gastroenterological and Pediatric Surgery
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama-machi, Yufu city, Oita
TEL
097-586-5843
Homepage URL
http://www.surgery1.med.oita-u.ac.jp
t-hasegawa@oita-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine
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
Department of Gastroenterological and Pediatric Surgery, Oita University Faculty of Medicine
Address
1-1 Idaigaoka, Hasama-machi, Yufu city, Oita
Tel
097-586-5843
t-hasegawa@oita-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
大分大学医学部 消化器・小児外科
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is exploratory, not a comparative controlled trial, and is conducted using surgical videos of laparoscopic gastrectomies, with no direct impact on patients. Therefore, consent is obtained through an opt-out approach, and due to the lack of necessity for strict randomization, a randomization center will not be established.
Management information
Registered date
| 2023 | Year | 11 | Month | 25 | Day |
Last modified on
| 2023 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060352
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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