Evaluation of the Efficacy and Safety of an AI Navigation Planning System in Transurethral Resection of Bladder Tumor: A Prospective, Randomized, Controlled, Single-Center Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Fudan University
- Enrollment
- 170
- Primary Endpoint
- Recurrence-Free Survival (RFS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Recurrence-Free Survival (RFS)
Time Frame: 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 Outcomes
- Surgical Duration(Day of surgery (intraoperative))
- Intraoperative Blood Loss(Day of surgery (intraoperative)
- Perioperative Bleeding Rate(Up to 14 days post-surgery)
- Number of Lesions Detected Intraoperatively(Day of surgery (intraoperative))
- Postoperative Residual Lesion Rate(Up to 3 months post-surgery)
- Surgery-Related Complication Rate(Up to 30 days post-surgery)
Investigators
Du Lingzhi
Principal Investigator
Fudan University