UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060611 |
|---|---|
| Receipt number | R000068815 |
| Scientific Title | A Randomized Controlled Trial of an AI-Based Adaptive 3D Navigation System to Assist Intraoperative Ultrasonography in Minimally Invasive Liver Resection |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2026/02/07 12:06:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study evaluating AI-based 3D navigation for anatomical understanding during intraoperative ultrasonography in minimally invasive liver resection
Acronym
AI-US (AI-assisted Intraoperative Decision-support with US) study
Scientific Title
A Randomized Controlled Trial of an AI-Based Adaptive 3D Navigation System to Assist Intraoperative Ultrasonography in Minimally Invasive Liver Resection
Scientific Title:Acronym
AI-US (AI-assisted Intraoperative Decision-support with US) study
Region
| Japan |
Condition
Condition
Patients deemed eligible for hepatectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to prospectively evaluate whether an AI-based adaptive 3D navigation system improves anatomical understanding during intraoperative ultrasonography in minimally invasive liver resection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to identify target anatomical structures (seconds)
Key secondary outcomes
Accuracy, Identification error (cm)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
AI based adaptive 3D navigation assisted intraoperative ultrasonography
Interventions/Control_2
conventional intraoperative ultrasound alone, without AI-assisted adaptive 3D navigation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Medical students and surgeons who are engaged in clinical training or surgical practice at our institution during the study period
Key exclusion criteria
None
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Ogiso |
Organization
Department of Surgery, Graduate School of Medicine, Kyoto University
Division name
Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
6068507
Address
54 Shogo-in Kawahara-cho, Sakyo-ku, Kyoto, JAPAN
TEL
+81-75-751-3242
ogiso@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Ogiso |
Organization
Department of Surgery, Graduate School of Medicine, Kyoto University
Division name
Division of Hepato-Biliary-Pancreatic Surgery and Transplantation
Zip code
6068507
Address
54 Shogo-in Kawahara-cho, Sakyo-ku, Kyoto, JAPAN
TEL
+81-75-751-3242
Homepage URL
ogiso@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Nakatani Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, JAPAN
Tel
+81-75-366-7618
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | 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
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
| 2025 | Year | 12 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 02 | Month | 07 | Day |
Last modified on
| 2026 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068815
