Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060687) titled 'A knowledge-generating multicenter prospective study: intraoperative near-infrared fluorescence ureteral navigation-guided dissection in oncologically difficult colorectal cancer surgery' on April 1.

Study Type: Observational

Primary Sponsor: Institute - Kawaguchi Municipal Medical Center

Condition: Condition - Colorectal Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - This study aims to evaluate the multifaceted clinical significance of fluorescent ureteral navigation (FUN) in colorectal cancer surgery by prospectively collecting multicenter data on treatment outcomes using near-infrared fluorescence ureteral catheters or the IRIS U Kit. Specifically, we will assess the impact of FUN on the incidence of ureteral injury, conversion to open surgery, R0 resection rate, pathological circumferential resection margin positivity rate, incidence of adverse events, and surgeon workload. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1. Patients with colorectal cancer (including appendix, rectum, and anus) histologically diagnosed as malignant tumors (pap, tub, por, muc, sig, or med). 2. Patients aged between 18 and 85 years. 3. Patients judged by the attending physician to be at high risk of ureteral injury. 4. Patients undergoing surgery using fluorescent ureteral navigation (FUN) with either the NIRC fluorescent ureteral catheter or the IRIS U Kit. 5. Patients scheduled for minimally invasive surgery (laparoscopic or robot-assisted). 6. Patients who have received a full explanation of the study, have sufficient understanding, and have provided written informed consent of their own free will prior to participation. Key exclusion criteria - 1. Patients requiring emergency surgery. 2. Patients scheduled to undergo open surgery or planned intraoperative conversion to open surgery (excluding laparotomy for reconstruction purposes). 3. Patients with severe comorbidities (e.g., cardiac disease, pulmonary disease, bleeding tendency, or poorly controlled hypertension or diabetes mellitus). 4. Patients deemed inappropriate for inclusion in the study by the principal investigator or sub-investigators. Target Size - 330

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 15 Day Date of IRB - 2026 Year 02 Month 20 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069413

Disclaimer: Curated by HT Syndication.