A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial Nephrectomy for Renal Complex Tumor (UroCCR N°99)
NCT ID: NCT05572216
Last Updated: 2024-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
694 participants
INTERVENTIONAL
2023-01-24
2027-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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conventional group
Robot-Assisted Partial Nephrectomy without 3D navigation
No interventions assigned to this group
3D IGRAPN GROUP
Robot-Assisted Partial Nephrectomy with 3D navigation
Robot assisted partial nephrectomy with 3D image guidance
patient have a partial nephrectomy for renal complex tumor
Interventions
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Robot assisted partial nephrectomy with 3D image guidance
patient have a partial nephrectomy for renal complex tumor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Jean-Luc DESCOTES, Pr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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University Hospital Grenoble
Grenoble, , France
university HospitalGrenoble
Grenoble, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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EssaiClinique_ACCURATE
Identifier Type: -
Identifier Source: org_study_id
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