Clinical Trial Protocol for ACCURATE: A CCafU-UroCCR Randomized Trial: Three-dimensional Image-guided Robot-assisted...

Area of Science:

• Urology
• Surgical Oncology
• Medical Imaging

Background:

• Renal cancer treatment often necessitates nephron-sparing surgery.
• Advancements in imaging and robotic surgery require further enhancement for precision and renal preservation.
• Current standard robot-assisted partial nephrectomy has limitations in optimizing surgical outcomes.

Purpose of the Study:

• To evaluate the effectiveness of three-dimensional (3D) image-guided robot-assisted partial nephrectomy.
• To compare the new technique against standard robot-assisted surgery for improving surgical precision and renal preservation.
• To assess the impact on patient outcomes, including oncological control and kidney function.

Main Methods:

• A prospective, 1:1 randomized, single-blind phase 3 superiority study.
• Conducted across 14 centers with 694 planned patient enrollments over 36 months.
• Primary endpoint: composite trifecta score (negative margins, no complications, preserved renal function).

Main Results:

• The study is designed to determine if 3D image-guided robot-assisted partial nephrectomy offers superior outcomes.
• It aims to demonstrate enhanced surgical accuracy and improved kidney function preservation.
• The trial will provide data on oncological efficacy, perioperative parameters, and economic impact.

Conclusions:

• The 3D image-guided technique is expected to enhance precision in kidney tumor removal.
• This approach has the potential to set a new standard in robotic partial nephrectomy.
• The study will validate the safety and efficacy of advanced 3D imaging in robot-assisted renal surgery.