Recruiting
Not applicable
Using 3D Kidney Model Based on Artificial Intelligence to Assist Partial Nephrectomy: A Prospective Validation Study
Condition(s) studied
Renal Cell Cancer
Investigational drug(s) / intervention(s)
an AI-based real-time image-guided kidney model system
an AI-based real-time image-guided kidney model system: Use the AI-model to locate kidney and tumour, assisting surgeon with the operation
Study 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?
Eligibility
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
Primary outcome measure(s)
Operative Time — Intraoperative
Trial sites (2)
Facility City Region Status
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing
Jiangsu
Not Yet Recruiting
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Nanjing
Jiangsu
Recruiting
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