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

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate peri and post-operative outcomes as well as long-term survival of 3D IGRAPN compared to conventional Robot-Assisted Partial Nephrectomy (RAPN) for moderate and highly complex renal tumors. The main questions aim to answer: peri-operative complications oncological safety long term renal function Participants will be asked to do undergo 3D-IGRAPN. Researchers will compare 3D-IGRAPN to RAPN to see if peri-operative outcomes are better in the experimental group.

Detailed Description
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Robot-assisted partial nephrectomy (RAPN) is the standard treatment for localized kidney tumors. New 3D modeling and reconstruction technologies have enabled the development of real time imageguided surgery using virtual reality (VR). In view of advances in artificial intelligence and surface recognition based on deep-learning, augmented reality (AR) by merging a 3D reconstructed virtual image onto the real per-operative view represents the next step in image-guided surgery. 3D IG-RAPN using Synapse 3D (Fujifilm) and DaVinci Tile-Pro display (Intuitive Surgical) vs conventional RAPN without 3D navigation in 12 high-volume urological centers from the UroCCR Network. Outcoume : Primary endpoint is a composite validated score (TRIFECTA) evaluating peri-operative complications as well as oncological safety and long-term renal function preservation. Secondary endpoints assess long-term survival, ergonomics and surgeon satisfaction. A medico-economic evaluation will be performed. Methodology: ACCURATE is a nation-wide, single-blind, multicentric, prospective randomized controlled trial enrolling 694 patients with a single complex renal mass, defined as RENAL NS≥7. Randomization (1:1) between the experimental and the conventional group will take place on day of inclusion and will be stratified by center.

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

Conditions
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Renal Tumor, Renal Cancer

Intervention / Treatment
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* Procedure: Robot assisted partial nephrectomy with 3D image guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years Indication of RAPN for suspicious renal tumor Moderate or high complexity renal tumor (RENAL Nephrometry Score (NS) >7) Da Vinci® surgical system available for the surgery Patient affiliated to the French social security system or an equivalent system Signed informed consent form UroCCR and ACCURATE Exclusion Criteria: Medical contraindication to RAPN Renal insufficiency forbidding iodine injection Patient with allergy to iodinated contrast products Patient concerned by articles L1121-5 to 8 of the French public health code (protected persons)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: ACCURATE is a nation-wide, single-blind, multicentric, prospective randomized controlled trial enrolling patients with a single complex renal mass, defined as RENAL NS≥7. Randomization (1:1) between the experimental and the conventional group will take place on day of inclusion and will be stratified by center.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: conventional group<br>Robot-Assisted Partial Nephrectomy without 3D navigation | |
| Experimental: 3D IGRAPN GROUP<br>Robot-Assisted Partial Nephrectomy with 3D navigation | Procedure: Robot assisted partial nephrectomy with 3D image guidance<br>* patient have a partial nephrectomy for renal complex tumor<br>* Other names: without 3D image guidance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TRIFECTA score | evaluating peri-operative outcome complications as well as oncological safety and long-term renal function preservation. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival | Recurrence-free survival and Overall survival | 2 and 5 years | 
| Overall survival | Overall Survival | 2 and 5 years | 
| Number of Conversion to radical nephrectomy | Need to convert to radical nephrectomy for intra-operative reasons | Intraopertively | 
| rate of Off clamp or superselective ischemia | use of techniques without renal artery clamping | Intraoperatively | 
| Amount of parenchyma preserved (according to CT scan) | Preservation of safe kidney | Month 6 | 
| Blood loss | Blood loss | Intra-operatively | 
| NASA TLX | Ergonomy score (questionnaire completed at the end of the procedure by the surgeon) | at the end of the surgery | 
| Warm ischemia time | Warm ischemia time | Intra-operatively | 
| Medico-economic evaluation | ncremental cost-utility ratio (ICUR) expressed as the extra cost per a QALY gained by the 3D-IGRAPN strategy compared to standard RAPN. | Month 1 and 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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image guidance, augmented reality, robotics