AI-Guided TURBT for Bladder Cancer (AITURBT)

Nessun intervento: control

Participants in the control group undergo conventional Transurethral Resection of Bladder Tumor (TURBT) following standard clinical guidelines. The surgeon determines tumor margins and resection range based solely on white-light cystoscopy findings and personal clinical experience, without the use of the AI navigation planning system. All perioperative management, including anesthesia, postoperative care, and follow-up protocols, is identical to that of the experimental group.

Sperimentale: AI-navigation

Participants in the experimental group undergo standard TURBT with the assistance of the AI navigation planning system. During surgery, the real-time cystoscopic video is processed by the system, which automatically identifies suspicious tumor regions and dynamically displays recommended resection margins as visual overlays on the surgical monitor. The surgeon integrates this AI-generated information with clinical judgment to determine the final resection plan, with the ultimate decision-making authority remaining with the surgeon at all times. All perioperative management, including anesthesia, postoperative care, and follow-up protocols, is identical to that of the control group.

Dispositivo: AI Navigation Planning System

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.

Surgical Duration

Time from cystoscope entry into the bladder to successful placement of the urinary catheter at the end of surgery, recorded in minutes.

Intraoperative Blood Loss

Total blood loss during surgery, calculated by suction canister fluid minus irrigation fluid plus gauze weighing method, recorded in milliliters (mL).

Perioperative Bleeding Rate

Proportion of participants experiencing bleeding requiring interventional therapy, unplanned reoperation, or blood transfusion within 14 days post-surgery.

Number of Lesions Detected Intraoperatively

Total number of tumor lesions identified and documented during the surgical procedure.

Postoperative Residual Lesion Rate

Proportion of participants with residual or newly detected lesions at the first postoperative cystoscopy follow-up visit.

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.