AI-Guided TURBT for Bladder Cancer | NCT07727343

NCT07727343

Overview

NCT ID: NCT07727343
Lead Sponsor: Fudan UniversityOTHER
Official Title: 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
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.
Conditions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: May 31, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 170Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: Lingzhi Du, MDContact
20301050222@fudan.edu.cn+86-19839759960

Similar Studies

Participant Group/Arms

controlNo Intervention

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.

AI-navigationExperimental

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.

Device: AI Navigation Planning System