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

Grenoble Alpes University Hospital Center (CHU)

Status

Enrolling

Conditions

Renal Cancer

Renal Tumor

Treatments

Procedure: Robot assisted partial nephrectomy with 3D image guidance

Study type

Interventional

Funder types

Other

Identifiers

NCT05572216

EssaiClinique_ACCURATE

Details and patient eligibility

About

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.

Full 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.

Enrollment

694 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)