An interventional study of Robot assisted partial nephrectomy with 3D image guidance in Renal Tumor and Renal Cancer, sponsored by University Hospital, Grenoble. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Treatment
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.
956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.
This study's planned enrollment of 694 is above the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.
Browse Kidney Neoplasms studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Robot-Assisted Partial Nephrectomy without 3D navigation
Robot-Assisted Partial Nephrectomy with 3D navigation
Procedure: Robot assisted partial nephrectomy with 3D image guidance
patient have a partial nephrectomy for renal complex tumor
Also known as: without 3D image guidance
TRIFECTA score
evaluating peri-operative outcome complications as well as oncological safety and long-term renal function preservation.
Time frame: 1 month
Recurrence free survival
Recurrence-free survival and Overall survival
Time frame: 2 and 5 years
Overall survival
Overall Survival
Time frame: 2 and 5 years
Number of Conversion to radical nephrectomy
Need to convert to radical nephrectomy for intra-operative reasons
Time frame: Intraopertively
rate of Off clamp or superselective ischemia
use of techniques without renal artery clamping
Time frame: Intraoperatively
Amount of parenchyma preserved (according to CT scan)
Preservation of safe kidney
Time frame: Month 6
Blood loss
Blood loss
Time frame: Intra-operatively
NASA TLX
Ergonomy score (questionnaire completed at the end of the procedure by the surgeon)
Time frame: at the end of the surgery
Warm ischemia time
Warm ischemia time
Time frame: 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.
Time frame: Month 1 and 6
Plan to share: No
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University Hospital, Grenoble