Clinical Trial Protocol for ACCURATE: A CCafU-UroCCR Randomized Trial: Three-dimensional Image-guided Robot-assisted Partial Nephrectomy for Renal Complex Tumor (UroCCR 99)
Résumé
Background and Objective: Renal cancer often requires nephron-sparing surgery for optimal patient outcomes. Despite advances in imaging and robot-assisted surgery, there is a need to enhance surgical precision and renal preservation. This trial evaluates the effectiveness of 3D Image-Guided Robot-Assisted Partial Nephrectomy (3D-IGRAPN) versus standard methods in improving surgical outcomes. Clinical Trial Design and Timeframe: This trial is a prospective, 1:1 randomized, single-blind phase III superiority study conducted across 14 centers within the French Network for Research on Kidney Cancer, aiming to enroll 694 patients over 36 months. Endpoints: The primary endpoint is a composite TRIFECTA score, including negative surgical margins, no complications, and renal function preservation (eGFR >90% at 1 month). Secondary endpoints include oncological outcomes, conversion rates, perioperative parameters, and economic evaluation. Data Sources and Statistical Analysis Plan: Data is collected via the UroCCR database. Logistic regression will analyze the primary endpoint, and various regression methods will address secondary outcomes. Economic evaluations involve Incremental Cost-Utility and Cost-Effectiveness Ratios.
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