Renal Cell Cancer
Conditions
Keywords
partial nephrectomy, Articicial Intelligence, Intraoperative Real-Time Navigation
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.
Interventions
PROCEDUREan AI-based real-time image-guided kidney model system
Use the AI-model to locate kidney and tumour, assisting surgeon with the operation
Sponsors
Southeast University, China
Shao Pengfei
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Operative Time | Intraoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operating Surgeon's Assessment | immediately after the surgery | Scoring for Each Surgery(0-5) by navigation accuracy, image rendering smoothness |
Countries
China
Contacts
Primary ContactPengfei Shao, Professor
Backup ContactHaoqi Miao, Postgraduate
Outcome results
None listed