UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061923 |
|---|---|
| Receipt number | R000070856 |
| Scientific Title | A multicenter prospective registry study on AI-based visual assistance in minimally invasive surgery for locally advanced rectal cancer |
| Date of disclosure of the study information | 2026/06/16 |
| Last modified on | 2026/06/16 00:56:39 |
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Basic information
Public title
A multicenter prospective registry study on AI-based visual assistance in minimally invasive surgery for locally advanced rectal cancer
Acronym
A multicenter prospective registry study on AI-based visual assistance in minimally invasive surgery for locally advanced rectal cancer
Scientific Title
A multicenter prospective registry study on AI-based visual assistance in minimally invasive surgery for locally advanced rectal cancer
Scientific Title:Acronym
A multicenter prospective registry study on AI-based visual assistance in minimally invasive surgery for locally advanced rectal cancer
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The clinical effectiveness of AI-based surgical visual assistance programs in improving surgical outcomes has not yet been established. Quantitative evaluation of such programs among surgeons with different levels of expertise may help reduce technical disparities and promote standardized, high-quality minimally invasive surgery. This study aims to evaluate the clinical effectiveness of the AI-based surgical visual assistance program EUREKA in minimally invasive surgery for patients with locally advanced rectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cohort A:Console time (minutes)
Cohort B:Pathological circumferential resection margin (CRM) positivity rate
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histologically confirmed rectal adenocarcinoma (papillary, tubular, poorly differentiated, mucinous, signet-ring cell, medullary, or adenosquamous carcinoma) based on endoscopic biopsy of the primary rectal lesion.
2. Patients diagnosed as having resectable disease based on preoperative assessment and imaging findings.
3. Tumors located in the rectosigmoid colon (RS), upper rectum (Ra), lower rectum (Rb), or anal canal (P).
4. Rectal cancer with the lower tumor border located within 12 cm from the anal verge and meeting either of the following criteria:
cT2-T4a, cN0-N3, and cM0; or
cT1-T4a, cN1-N3, and cM0.
For patients who received neoadjuvant treatment, staging is based on findings obtained before initiation of the preoperative treatment.
5. Cohort A:
Patients scheduled to undergo robot-assisted rectal resection in routine clinical practice performed by a surgeon certified by the Japan Society for Endoscopic Surgery (JSES) Endoscopic Surgical Skill Qualification System and having experience of at least 40 robot-assisted rectal cancer procedures.
Cohort B:
Patients scheduled to undergo laparoscopic or robot-assisted rectal resection in routine clinical practice performed by a surgeon with experience of fewer than 20 rectal cancer procedures (laparoscopic and robot-assisted procedures combined) at the time of study initiation at each participating institution.
6. Patients considered unsuitable for local endoscopic resection.
7. Patients aged 18 to 85 years.
8. Written informed consent for participation in this study obtained from the patient prior to enrollment.
Key exclusion criteria
1. Patients with cT4b disease. For patients who received neoadjuvant treatment, staging is based on findings obtained before initiation of the preoperative treatment.
2. Cohort A only: Patients scheduled to undergo transanal total mesorectal excision (TaTME).
3. Patients scheduled to undergo lateral lymph node dissection.
4. Patients with multiple colorectal cancers (except Tis lesions).
5. Patients with active multiple primary cancers, defined as synchronous multiple cancers or metachronous multiple cancers with a disease-free interval of less than 5 years. However, carcinoma in situ or intramucosal carcinoma considered cured by local treatment is not regarded as an active multiple primary cancer.
6. Patients with severe comorbidities or dementia.
7. Patients considered inappropriate for study participation by the principal investigator or a sub-investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Takemasa |
Organization
Osaka International Medical and Science Center, Osaka Keisatsu Hospital
Division name
Department of Surgery
Zip code
543-8922
Address
Karasugatsuji 2-6-40, Tennouji-ku, Osaka City, Osaka
TEL
06-6771-6051
itakemasa@oim.or.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Miyo |
Organization
Osaka International Cancer Institute
Division name
Department of Gastroenterological Surgery
Zip code
541-8567
Address
3-1-69 Otemae, Chuo-ku, Osaka
TEL
06-6945-1181
Homepage URL
masaaki.miyo@oici.jp
Sponsor or person
Institute
Osaka International Medical and Science Center, Osaka Keisatsu Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
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
Ethics Committee of Osaka International Medical and Science Center Osaka Keisatsu Hospital
Address
Karasugatsuji 2-6-40, Tennouji-ku, Osaka City, Osaka
Tel
06-6771-6051
shomu@oim.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
24he2932011j0001
Org. issuing International ID_1
Japan Agency for Medical Research and Development (AMED)
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 | 06 | Month | 16 | 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
| 2026 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter prospective observational study designed to evaluate the clinical effectiveness of the AI-based surgical visual assistance program EUREKA in minimally invasive rectal cancer surgery. The primary endpoint is console time in Cohort A and the pathological circumferential resection margin (CRM) positivity rate in Cohort B.
Management information
Registered date
| 2026 | Year | 06 | Month | 16 | Day |
Last modified on
| 2026 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070856
