A Prospective Study Evaluating the Safety, Urinary Function-Preserving Effect, and Institutional Implementation Impact of EUREKA, a Surgical Image Recognition Support Program
EUREKA study (EUREKA study)
Hanaoka Marie
Institute of Science Tokyo
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
+81-358035254
hanasrg1@tmd.ac.jp
Hanaoka Marie
Institute of Science Tokyo
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
+81-358035254
hanasrg1@tmd.ac.jp
Recruiting
June. 02, 2026
20
Interventional
non-randomized controlled trial
open(masking not used)
historical control
single assignment
treatment purpose
Patients aged 18 years or older at the time of registration.
Patients with an ECOG PS of 0 or 1.
Patients whose primary tumor is located in the rectum based on a comprehensive preoperative diagnosis using endoscopy and imaging examinations, including barium enema examination or upper abdominal and pelvic CT.
Patients histopathologically diagnosed with colorectal cancer, including adenocarcinoma, mucinous carcinoma, signet ring cell carcinoma, or adenosquamous carcinoma, based on endoscopic biopsy of the primary colorectal lesion.
Patients with a preoperative diagnosis of cT1 to cT4 according to the 8th edition of the TNM classification. Patients with direct invasion to other organs, classified as SI or AI according to the 9th edition of the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma, will be excluded. There are no restrictions on cN or cM stage.
Patients scheduled to undergo robot assisted low anterior resection, intersphincteric resection, or abdominoperineal resection. Patients scheduled to undergo lateral lymph node dissection will be excluded.
Patients who provide written informed consent to participate in this study.
ECOG PS, Eastern Cooperative Oncology Group Performance Status, is a scale used to assess the general condition of patients with cancer, ranging from 0, fully active, to 5, death. In this study, patients with PS 0 or 1, who are almost fully independent in daily life, will be included.
Patients with an infection requiring systemic treatment.
Patients with a fever of 38.0 C or higher at the time of registration.
Patients with uncontrolled diabetes mellitus.
Patients with uncontrolled hypertension.
Patients with unstable angina, defined as angina that developed or worsened within the previous 3 weeks, or a history of myocardial infarction within the previous 6 months.
Patients with uncontrolled valvular heart disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
Patients with a psychiatric disorder or psychiatric symptoms that interfere with daily life and are judged to make participation in the study difficult.
Patients who require conversion to open surgery during the operation.
Patients in whom the planned surgical procedure is not performed.
Patients with a history of pelvic surgery, such as rectal resection, radical prostatectomy, or total hysterectomy, or a history of radiation therapy to pelvic organs.
Patients with severe preoperative urinary dysfunction.
Patients receiving continuous systemic administration of corticosteroids or other immunosuppressive drugs, either orally or intravenously.
Women who are pregnant, possibly pregnant, within 28 days after delivery, or breastfeeding.
Patients who are judged by the principal investigator or subinvestigator to be unsuitable for participation in this study.
18age old over
No limit
Both
Rectum tumor
This is a prospective single arm open label pilot study. The study will evaluate the safety and effectiveness of intraoperative anatomical structure visualization using EUREKA during robot assisted colectomy. The results will be compared with historical data from robot assisted colectomy.
Surgery will be performed according to standard surgical procedures. During surgery, real time images analyzed by EUREKA will be shown as a split screen image on the same monitor as the operative field. The surgeon can refer to the EUREKA display when needed.
The surgical robot will be connected to EUREKA using an SDI cable. The images analyzed by EUREKA will be shown as a split screen display. The whole surgical procedure, including the monitor placed next to the surgical console, will be video recorded. A third party not directly involved in the study will later assess whether the surgeon referred to the EUREKA display during surgery. This assessment will be based on objective video records, not self reporting.
The primary endpoint is the incidence of intraoperative and postoperative complications. This will be compared between patients treated with EUREKA and historical controls. Secondary endpoints include postoperative urinary dysfunction, educational effect for surgeons and students, accuracy of EUREKA image analysis, and reduction of burden on supervising surgeons. These will be assessed by questionnaires.
Rectum tumor Recum cancer
Real-time intraoperative image-recognition
D012004
D025321
Early intraoperative and postoperative outcomes
Operative time, blood loss, time to initiation of oral intake, and postoperative length of hospital stay will be evaluated.
Postoperative urinary dysfunction
The frequency of postoperative urinary dysfunction will be assessed in all eligible patients. It will be compared with historical controls using Fisher exact test.
Educational effect for surgeons
The educational effect of EUREKA for surgeons will be assessed by questionnaire during real-time use in surgery.
Accuracy of EUREKA
The accuracy of EUREKA will be assessed by surgeons using a questionnaire during real-time use in surgery.
Reduction of burden on supervising surgeons
The effect of EUREKA on reducing the burden on supervising surgeons will be assessed by questionnaire during intraoperative instruction.
Educational effect for medical students
Medical students who observe the surgery during clinical training at Institute of Science Tokyo Hospital will complete a questionnaire. The questionnaire will assess whether EUREKA improves their understanding of the surgical procedure and learning effect.
None
Clinical Research Review Committee, Institute of Science Tokyo
