This prospective, randomized, controlled, single-center study evaluates whether an AI navigation planning system used during Transurethral Resection of Bladder Tumor (TURBT) can improve recurrence-free survival in patients with non-muscle invasive bladder cancer. Participants are randomized to receive either standard TURBT surgery or standard TURBT with AI-assisted real-time tumor identification and resection margin guidance. The primary outcome is recurrence-free survival, with secondary outcomes including surgical duration, intraoperative blood loss, perioperative bleeding, and complication rates. The study aims to provide high-level evidence on the clinical utility of AI-assisted surgical navigation in bladder cancer treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
170
The AI Navigation Planning System is a software-based medical device that processes real-time video from a standard cystoscope during TURBT. It uses deep learning algorithms to automatically identify suspicious tumor regions and perform semantic segmentation of tumor boundaries on the endoscopic video stream. The system overlays the identified tumor areas and dynamically recommended resection margins onto the surgical monitor as visual guidance for the surgeon. The system achieves a diagnostic accuracy of 97% and an AUC of 0.97 in multi-center validation. It is designed to assist surgeons in achieving more complete tumor resection by reducing reliance on subjective visual assessment alone. The system operates locally on a standard workstation without requiring internet connectivity, ensuring data security.
Recurrence-Free Survival (RFS)
Time from surgery to the first occurrence of tumor recurrence confirmed by imaging (CT/MRI/ultrasound) or cystoscopy with pathological biopsy, or death from any cause, whichever occurs first. Participants without an event at the end of follow-up will be censored at the date of the last known follow-up visit.
Time frame: Time Frame: Up to 24 months post-surgery
Surgical Duration
Time from cystoscope entry into the bladder to successful placement of the urinary catheter at the end of surgery, recorded in minutes.
Time frame: Day of surgery (intraoperative)
Intraoperative Blood Loss
Total blood loss during surgery, calculated by suction canister fluid minus irrigation fluid plus gauze weighing method, recorded in milliliters (mL).
Time frame: Day of surgery (intraoperative
Perioperative Bleeding Rate
Proportion of participants experiencing bleeding requiring interventional therapy, unplanned reoperation, or blood transfusion within 14 days post-surgery.
Time frame: Up to 14 days post-surgery
Number of Lesions Detected Intraoperatively
Total number of tumor lesions identified and documented during the surgical procedure.
Time frame: Day of surgery (intraoperative)
Postoperative Residual Lesion Rate
Proportion of participants with residual or newly detected lesions at the first postoperative cystoscopy follow-up visit.
Time frame: Up to 3 months post-surgery
Surgery-Related Complication Rate
Incidence and severity of postoperative complications graded according to the Clavien-Dindo Classification (Grade I to V) within 30 days post-surgery.
Time frame: Up to 30 days post-surgery
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