Bladder Cancer
Conditions
Brief summary
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.
Interventions
DEVICEAI 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.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Participants are randomly allocated in a 1:1 ratio to either the experimental group (TURBT with AI navigation planning system) or the control group (conventional TURBT without AI assistance). Assignment is parallel, with no crossover between groups. All other perioperative management, including anesthesia, postoperative care, and follow-up protocols, is identical between the two groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 75 years, male or female. * Clinical or imaging diagnosis of non-muscle invasive bladder cancer (NMIBC) according to international diagnostic standards (CT, MRI, ultrasound, cystoscopy). * Medically fit for TURBT surgery, with normal or essentially normal renal, cardiopulmonary, and hepatic function. * Willing and able to provide written informed consent (signed by the patient or a legally authorized representative).
Exclusion criteria
* Pregnant or lactating women. * Severe dysfunction of other vital organs (heart, lungs, kidneys, etc.). * Imaging evidence of distant metastases. * Severe infection or active inflammation. * Psychiatric disorders or inability to comply with study procedures. * Any other condition deemed by the investigator as inappropriate for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-Free Survival (RFS) | Time Frame: Up to 24 months post-surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Duration | Day of surgery (intraoperative) | 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 | Day of surgery (intraoperative | Total blood loss during surgery, calculated by suction canister fluid minus irrigation fluid plus gauze weighing method, recorded in milliliters (mL). |
| Perioperative Bleeding Rate | Up to 14 days post-surgery | Proportion of participants experiencing bleeding requiring interventional therapy, unplanned reoperation, or blood transfusion within 14 days post-surgery. |
| Number of Lesions Detected Intraoperatively | Day of surgery (intraoperative) | Total number of tumor lesions identified and documented during the surgical procedure. |
| Postoperative Residual Lesion Rate | Up to 3 months post-surgery | Proportion of participants with residual or newly detected lesions at the first postoperative cystoscopy follow-up visit. |
| Surgery-Related Complication Rate | Up to 30 days post-surgery | Incidence and severity of postoperative complications graded according to the Clavien-Dindo Classification (Grade I to V) within 30 days post-surgery. |
Contacts
CONTACTLingzhi Du, MD
CONTACTJiajun Wang, MD
STUDY_DIRECTORJiajun Wang, MD
Fudan University
Outcome results
None listed