Tokyo, June 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061923) titled 'A multicenter prospective registry study on AI-based visual assistance in minimally invasive surgery for locally advanced rectal cancer' on June 16.

Study Type: Observational

Primary Sponsor: Institute - Osaka International Medical and Science Center, Osaka Keisatsu Hospital

Condition: Condition - Rectal cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: 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

Eligibility: Age-lower limit - 18 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 Size - 300

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 28 Day Anticipated trial start date - 2026 Year 06 Month 29 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070856

Disclaimer: Curated by HT Syndication.