Renal Cancer, Renal Tumor
Conditions
Keywords
image guidance, augmented reality, robotics
Brief summary
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
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.
Interventions
PROCEDURERobot assisted partial nephrectomy with 3D image guidance
patient have a partial nephrectomy for renal complex tumor
Sponsors
University Hospital, Grenoble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
single blind
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TRIFECTA score | 1 month | evaluating peri-operative outcome complications as well as oncological safety and long-term renal function preservation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 2 and 5 years | Overall Survival |
| Number of Conversion to radical nephrectomy | Intraopertively | Need to convert to radical nephrectomy for intra-operative reasons |
| rate of Off clamp or superselective ischemia | Intraoperatively | use of techniques without renal artery clamping |
| Amount of parenchyma preserved (according to CT scan) | Month 6 | Preservation of safe kidney |
| Recurrence free survival | 2 and 5 years | Recurrence-free survival and Overall survival |
| NASA TLX | at the end of the surgery | Ergonomy score (questionnaire completed at the end of the procedure by the surgeon) |
| Warm ischemia time | Intra-operatively | Warm ischemia time |
| Medico-economic evaluation | Month 1 and 6 | ncremental cost-utility ratio (ICUR) expressed as the extra cost per a QALY gained by the 3D-IGRAPN strategy compared to standard RAPN. |
| Blood loss | Intra-operatively | Blood loss |
Countries
France
Contacts
Primary ContactJean-Luc DESCOTES, Pr
Backup ContactASSILAH BOUZIT
Outcome results
None listed