Clinical trial NCT05572216: A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial Nephrectomy for Renal Complex Tumor (UroCCR N°99)
Official title: A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial Nephrectomy for Renal Complex Tumor (UroCCR N°99)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Tumor
Renal Cancer
Keywords: image guidance
augmented reality
robotics
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 694
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: TRIFECTA score
timeFrame: 1 month
Secondary outcomes:
measure: Recurrence free survival
timeFrame: 2 and 5 years
measure: Overall survival
timeFrame: 2 and 5 years
measure: Number of Conversion to radical nephrectomy
timeFrame: Intraopertively
measure: rate of Off clamp or superselective ischemia
timeFrame: Intraoperatively
measure: Amount of parenchyma preserved (according to CT scan)
timeFrame: Month 6
measure: Blood loss
timeFrame: Intra-operatively
measure: NASA TLX
timeFrame: at the end of the surgery
measure: Warm ischemia time
timeFrame: Intra-operatively
measure: Medico-economic evaluation
timeFrame: Month 1 and 6
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital Grenoble
city: Grenoble
country: France
facility: university HospitalGrenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Luc DESCOTES, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Michiels C, Khene ZE, Prudhomme T, Boulenger de Hauteclocque A, Cornelis FH, Percot M, Simeon H, Dupitout L, Bensadoun H, Capon G, Alezra E, Estrade V, Bladou F, Robert G, Ferriere JM, Grenier N, Doumerc N, Bensalah K, Bernhard JC. 3D-Image guided robotic-assisted partial nephrectomy: a multi-institutional propensity score-matched analysis (UroCCR study 51). World J Urol. 2023 Feb;41(2):303-313. doi: 10.1007/s00345-021-03645-1. Epub 2021 Apr 2.
citation: Porpiglia F, Checcucci E, Amparore D, Piramide F, Volpi G, Granato S, Verri P, Manfredi M, Bellin A, Piazzolla P, Autorino R, Morra I, Fiori C, Mottrie A. Three-dimensional Augmented Reality Robot-assisted Partial Nephrectomy in Case of Complex Tumours (PADUA >/=10): A New Intraoperative Tool Overcoming the Ultrasound Guidance. Eur Urol. 2020 Aug;78(2):229-238. doi: 10.1016/j.eururo.2019.11.024. Epub 2019 Dec 30.
citation: Long JA, Fiard G, Giai J, Teyssier Y, Fontanell A, Overs C, Poncet D, Descotes JL, Rambeaud JJ, Moreau-Gaudry A, Ittobane T, Bouzit A, Bosson JL, Lanchon C. Superselective Ischemia in Robotic Partial Nephrectomy Does Not Provide Better Long-term Renal Function than Renal Artery Clamping in a Randomized Controlled Trial (EMERALD): Should We Take the Risk? Eur Urol Focus. 2022 May;8(3):769-776. doi: 10.1016/j.euf.2021.04.009. Epub 2021 Apr 27.