3D Image-Guided Robot-Assisted Partial Nephrectomy versus Conventional Robot-Assisted Partial Nephrectomy for Complex Renal Tumors: A Randomized Trial

What this Trial Is About

The trial investigates outcomes in adults with moderate to highly complex renal tumors undergoing partial nephrectomy. Specifically, it compares 3D image-guided robot-assisted partial nephrectomy (3D IGRAPN) to conventional robot-assisted partial nephrectomy (RAPN) to evaluate peri-operative complications, cancer control, and long-term kidney function. This prospective, randomized study enrolls patients with complex kidney tumors defined by a RENAL Nephrometry Score above 7. Participants are randomly assigned to either standard RAPN or the experimental 3D IGRAPN group, which uses advanced 3D modeling and augmented reality technologies during surgery. The surgery is performed with the Da Vinci surgical system across multiple high-volume centers. The study includes follow-up assessments at 1 month, 6 months, and up to 5 years to monitor outcomes including surgical complications, survival, kidney function, and surgeon experience. During the trial, patients will undergo surgery and receive evaluations such as CT scans, intraoperative monitoring of blood loss and ischemia time, and questionnaires on surgical ergonomics. Researchers will measure a composite TRIFECTA score at one month to assess the primary outcome. Long-term survival and recurrence will be reviewed at 2 and 5 years. A medico-economic evaluation will also be performed to understand the costs associated with each surgical approach.

A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial Nephrectomy for Renal Complex Tumor (UroCCR N°99)