Clinical Trial Protocol for ACCURATE: A CCafU-UroCCR Randomized Trial: Three-dimensional Image-guided Robot-assisted Partial Nephrectomy for Renal Complex Tumor (UroCCR 99).

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 three-dimensional image-guided robot-assisted partial nephrectomy versus standard methods in improving surgical outcomes.

CLINICAL TRIAL DESIGN AND TIMEFRAME

This trial is a prospective, 1:1 randomized, single-blind phase 3 superiority study conducted across 14 centers within the French Network for Research on Kidney Cancer, aiming to enroll 694 patients over 36 mo.

ENDPOINTS

The primary endpoint is a composite trifecta score, including negative surgical margins, no complications, and renal function preservation (estimated glomerular filtration rate >90% at 1 mo). The secondary endpoints include oncological outcomes, conversion rates, perioperative parameters, and economic evaluation.

DATA SOURCES AND STATISTICAL ANALYSIS PLAN

Data are collected via the UroCCR database. Logistic regression will analyze the primary endpoint, and various regression methods will address the secondary outcomes. Economic evaluations involve incremental cost-utility and cost-effectiveness ratios.

STRENGTHS AND LIMITATIONS

Strengths include the multicenter design and robust randomization. Limitations involve variability in surgeons' experience with the new three-dimensional technology and logistical challenges in technology adoption.

PATIENT SUMMARY

This clinical trial is designed to evaluate a new surgical technique for treating kidney tumors called three-dimensional (3D) image-guided robot-assisted partial nephrectomy. This study aims to determine whether this new method is more effective and safer than the current standard robot-assisted surgery by improving surgical precision and preserving kidney function. Kidney tumors require precise surgical removal to ensure the best outcomes for patients both during and after surgery. While robotic assistance has improved many surgeries, use of advanced 3D imaging during these procedures might enhance the surgeon's ability to operate with greater accuracy, potentially leading to better patient outcomes and fewer complications. Participants in the trial will undergo surgery using either the conventional robotic-assisted method or the new 3D image-guided technique. The method used for each participant will remain undisclosed to maintain the study's integrity. All participants will receive the highest standard of care, and their progress will be monitored closely throughout the trial. This study hopes to demonstrate that the 3D image-guided method can improve surgical precision and outcomes for patients undergoing kidney tumor removal. If successful, this technique could set a new standard for kidney surgery and improve the overall care patients receive in the future. The addition of 3D reconstruction to the surgery carries very little extra risk. If any technical issues occur, the surgeons can switch back to the regular method without affecting safety. The 3D technology we use, Synapse 3D, is approved and used in hospitals worldwide, ensuring that its safety is well proven by existing evidence.