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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- Operative Time
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: an AI-based real-time image-guided kidney model system (Procedure)
结局指标
主要结局
Operative Time
时间窗: Intraoperative
次要结局
- Operating Surgeon's Assessment(immediately after the surgery)
研究者
Shao Pengfei
chief physician
The First Affiliated Hospital with Nanjing Medical University