Artificial Intelligence-Driven 3D Kidney Model for Real-Time Augmented Reality and Surgical Navigation in Minimally Invasive (Robotic/Laparoscopic) Partial Nephrectomy: A Prospective Validation Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 232
- Locations
- 2
- Primary Endpoint
- Operative Time
Study Overview
Brief Summary
The goal of this study is to develop a real-time artificial intelligence-driven 3D kidney model to assist robotic or laparoscopic partial nephrectomy:
• Can this AI-powered model optimize the workflow of partial nephrectomy and enhance surgical benefits?
Detailed Description
This study aims to evaluate the feasibility of the AI-based real-time image-guided kidney model system in optimizing partial nephrectomy workflows. Patients scheduled for laparoscopic or robotic-assisted partial nephrectomy will be randomized to receive either AI-assisted surgical navigation (utilizing intraoperative 3D model overlay with automated registration) or conventional approaches. Comparative metrics will include ischemia time, margin positivity rate, and operative efficiency indices. Findings will inform iterative refinement of the system architecture based on clinical performance feedback.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ages 18-80 years, regardless of gender
- •Written informed consent obtained from the patient or legally authorized representative after full protocol disclosure
- •Preoperative imaging (CT/MRI) confirming clinical stage T1a or select T1b renal tumors suitable for partial nephrectomy (R.E.N.A.L. nephrometry score ≤10)
- •Localized renal tumors without lymph node/distant metastasis per NCCN Guidelines® (v2023)
- •Elective minimally invasive partial nephrectomy (laparoscopic/robotic) after comprehensive surgical counseling
Exclusion Criteria
- •Multifocal renal tumors (bilateral or unilateral)
- •Prior systemic anticancer therapy (targeted agents/immunotherapy/chemotherapy) within 6 months
- •Absolute surgical contraindications (e.g., ASA class ≥IV, uncontrolled coagulopathy)
- •Intraoperative conversion to radical nephrectomy or open approach
- •Postoperative adjuvant therapy during protocol-defined follow-up (12 months)
- •Major comorbidities (e.g., NYHA class III/IV heart failure, eGFR <30 mL/min/1.73m²) affecting outcome assessment
- •Concurrent enrollment in interventional clinical trials
- •Investigator-determined ineligibility based on risk-benefit analysis
Arms & Interventions
Conventional Surgical Approaches
perform conventional laparoscopic or robotic-assisted surgical approaches
AI model group
Use the AI-model to locate kidney and tumour, assisting surgeon with the operation
Intervention: an AI-based real-time image-guided kidney model system (Procedure)
Outcomes
Primary Outcomes
Operative Time
Time Frame: Intraoperative
Secondary Outcomes
- Operating Surgeon's Assessment(immediately after the surgery)
Investigators
Shao Pengfei
chief physician
The First Affiliated Hospital with Nanjing Medical University