UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059176 |
|---|---|
| Receipt number | R000067658 |
| Scientific Title | A Prospective Study on the Safety, Urinary Function Preservation, and Institutional Implementation of the Surgical Image Recognition Support Program |
| Date of disclosure of the study information | 2025/09/24 |
| Last modified on | 2025/09/24 16:02:18 |
* 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 Prospective Study on the Safety, Urinary Function Preservation, and Institutional Implementation of the Surgical Image Recognition Support Program
Acronym
EUREKAStudy
Scientific Title
A Prospective Study on the Safety, Urinary Function Preservation, and Institutional Implementation of the Surgical Image Recognition Support Program
Scientific Title:Acronym
EUREKAStudy
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is an exploratory prospective investigation targeting patients undergoing robot-assisted rectal resection. It aims to evaluate the safety of real-time use of the surgical visual support AI program EUREKA during surgery, as well as to examine whether the real-time visualization of nerves and the dissection plane may contribute to reducing the incidence of postoperative urinary dysfunction.
Basic objectives2
Others
Basic objectives -Others
In addition, the study will assess the educational impact of introducing EUREKA into the operating room on surgeons, the potential to reduce the burden on supervising surgeons, and the associated economic effects, thereby exploring incentives for institutional implementation of EUREKA.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
incidence of intraoperative and postoperative complications.
Key secondary outcomes
Perioperative course, including intraoperative and early postoperative outcomes
Incidence of postoperative urinary dysfunction
Questionnaire on the educational impact, accuracy, and reduction of supervisory burden associated with the use of EUREKA
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
During surgery, AI-analyzed anatomical structures will be displayed on TilePro and made available for reference at any time.
In cases where the operating surgeon does not view the AI analysis results even once throughout the procedure, the case will be excluded from the study analysis.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria will be enrolled in this clinical study:
Age 18 years of age or older at the time of registration.
Eastern Cooperative Oncology Group performance status of 0 or 1.
Patients whose primary tumor site is diagnosed as the rectum based on a comprehensive assessment using preoperative endoscopy and imaging: barium enema and/or abdominopelvic CT.
Patients histopathologically diagnosed with colorectal cancer: adenocarcinoma, mucinous carcinoma, signet-ring cell carcinoma, or adenosquamous carcinoma, by endoscopic biopsy of the primary colorectal lesion.
Preoperative diagnosis of cT1-4 (TNM Classification, 8th edition), excluding direct invasion into other organs (SI or AI according to the Japanese Classification of Colorectal Carcinoma, 9th edition). Clinical N and M stages are not restricted.
Patients scheduled to undergo robot-assisted low anterior resection, intersphincteric resection, or abdominoperineal resection. Cases requiring lateral pelvic lymph node dissection will be excluded.
Written informed consent for participation in this study is obtained from the patient.
Key exclusion criteria
Patients meeting any of the following criteria will be excluded from this study:
Presence of any of the following severe comorbidities:
Active infection requiring systemic therapy.
1.Fever 38.0 degrees Celsius or higher at the time of registration.
2.Uncontrolled diabetes mellitus.
3.Uncontrolled hypertension.
4.Unstable angina (angina newly developed or exacerbated within the past 3 weeks) or history of myocardial infarction within the past 6 months.
5.Uncontrolled valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
6.Psychiatric disorders or psychiatric symptoms that interfere with daily life and are judged to make participation in the study difficult.
7.Conversion to open surgery during the operation.
History of pelvic surgery (e.g., rectal resection, total prostatectomy, hysterectomy) or history of pelvic radiotherapy.
Presence of severe preoperative voiding dysfunction.
Ongoing systemic administration (oral or intravenous) of corticosteroids or other immunosuppressive agents.
Female patients who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding.
Any other condition judged by the principal investigator or sub-investigator to render the patient unsuitable for participation in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Marie |
| Middle name | |
| Last name | Hanaoka |
Organization
Institute of Science Tokyo
Division name
Department of Gastrointestinal Surgery
Zip code
113-8519
Address
1-5-45Yushima,Bunkyo-ku
TEL
09050750189
hanasrg1@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Marie |
| Middle name | |
| Last name | Hanaoka |
Organization
Institute of Science Tokyo
Division name
Department of Gastrointestinal Surgery
Zip code
153-0044
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
0358035254
Homepage URL
hanasrg1@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
0358035254
hanasrg1@tmd.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
| 2025 | Year | 09 | Month | 24 | 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 | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | 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
| 2025 | Year | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067658
