Virtual Interactive 3D Modeling to Improve Outcomes in Robot-Assisted Partial Nephrectomy: Clinical Trial Protocol for the Multicenter, Randomized 3DPN Study

摘要

The multicenter prospective randomized controlled 3DPN trial is investigating if virtual interactive 3D modeling improves outcomes of robot-assisted partial nephrectomy in comparison to standard-of-care computed tomography imaging. The study will assess clinical and oncological parameters, patient understanding, and surgeon confidence levels. 3DPN is a prospective, multicenter, randomized, controlled, two-armed open trial with planned recruitment of 370 patients in ten centers over a period of 24 mo. The trial is evaluating the value of virtual interactive 3D modeling for robot-assisted partial nephrectomy (RAPN) by assessing clinical outcomes, patient understanding, and surgeon confidence. Patients aged ≥18 yr with kidney tumors ≤7 cm who have contrast-enhanced computed tomography (CT) scans available and for whom RAPN with a da Vinci Surgical System is planned are eligible for the study. Using 1:1 randomization, patients are assigned to either the 3D model–based RAPN arm or the 2D CT scan–based RAPN arm. This trial is registered on ClinicalTrials.gov as NCT06056505.