A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial Nephrectomy for Renal Complex Tumor (UroCCR N°99)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robot assisted partial nephrectomy with 3D image guidance.
- Who it may be relevant to
- Registry conditions: Renal Tumor, Renal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure Robot assisted partial nephrectomy with 3D image guidance
patient have a partial nephrectomy for renal complex tumor
Primary outcome measures
- TRIFECTA score [Time frame: 1 month]
Secondary outcome measures (9)
- Recurrence free survival [Time frame: 2 and 5 years]
- Overall survival [Time frame: 2 and 5 years]
- Number of Conversion to radical nephrectomy [Time frame: Intraopertively]
- rate of Off clamp or superselective ischemia [Time frame: Intraoperatively]
- Amount of parenchyma preserved (according to CT scan) [Time frame: Month 6]
- Blood loss [Time frame: Intra-operatively]
- NASA TLX [Time frame: at the end of the surgery]
- Warm ischemia time [Time frame: Intra-operatively]
- Medico-economic evaluation [Time frame: Month 1 and 6]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 2 centers
- University Hospital Grenoble — Grenoble
- university HospitalGrenoble — Grenoble
Publications
- 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. d PMID 33811291
- 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. E PMID 31898992
- 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: PMID 33931361
Identifiers
NCT: NCT05572216 · EssaiClinique_ACCURATE