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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional group | No Intervention | Robot-Assisted Partial Nephrectomy without 3D navigation | |
| 3D IGRAPN GROUP | Experimental | Robot-Assisted Partial Nephrectomy with 3D navigation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot assisted partial nephrectomy with 3D image guidance | Procedure | patient have a partial nephrectomy for renal complex tumor |
|
| Measure | Description | Time Frame |
|---|---|---|
| TRIFECTA score | evaluating peri-operative outcome complications as well as oncological safety and long-term renal function preservation. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence free survival | Recurrence-free survival and Overall survival | 2 and 5 years |
| Overall survival | Overall Survival | 2 and 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Luc DESCOTES, Pr | Contact | 0476767642 | +33 | jldescotes@chu-grenoble.fr |
| ASSILAH BOUZIT | Contact | 0476767971 | +33 | abouzit@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Luc DESCOTES, Pr | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Grenoble | Recruiting | Grenoble | 38043 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33811291 | Result | 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. | |
| 31898992 |
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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.
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single blind
| Number of Conversion to radical nephrectomy | Need to convert to radical nephrectomy for intra-operative reasons | Intraopertively |
| rate of Off clamp or superselective ischemia | use of techniques without renal artery clamping | Intraoperatively |
| Amount of parenchyma preserved (according to CT scan) | Preservation of safe kidney | Month 6 |
| Blood loss | Blood loss | Intra-operatively |
| NASA TLX | Ergonomy score (questionnaire completed at the end of the procedure by the surgeon) | at the end of the surgery |
| Warm ischemia time | Warm ischemia time | Intra-operatively |
| Medico-economic evaluation | ncremental cost-utility ratio (ICUR) expressed as the extra cost per a QALY gained by the 3D-IGRAPN strategy compared to standard RAPN. | Month 1 and 6 |
| university HospitalGrenoble | Recruiting | Grenoble | 38043 | France |
|
| Result |
| 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. |
| 33931361 | Result | 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. |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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