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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05572216
Other study ID # EssaiClinique_ACCURATE
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2022
Est. completion date November 2027

Study information

Verified date August 2022
Source University Hospital, Grenoble
Contact Jean-Alexandre LONG, Pr
Phone 0476767642
Email jalong@chu-grenoble.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 694
Est. completion date November 2027
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Robot assisted partial nephrectomy with 3D image guidance
patient have a partial nephrectomy for renal complex tumor

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

References & Publications (3)

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 Fun — View 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 — View 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 (P — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary TRIFECTA score evaluating peri-operative outcome complications as well as oncological safety and long-term renal function preservation. 1 month
Secondary Recurrence free survival Recurrence-free survival and Overall survival 2 and 5 years
Secondary Overall survival Overall Survival 2 and 5 years
Secondary Number of Conversion to radical nephrectomy Need to convert to radical nephrectomy for intra-operative reasons Intraopertively
Secondary rate of Off clamp or superselective ischemia use of techniques without renal artery clamping Intraoperatively
Secondary Amount of parenchyma preserved (according to CT scan) Preservation of safe kidney Month 6
Secondary Blood loss Blood loss Intra-operatively
Secondary NASA TLX Ergonomy score (questionnaire completed at the end of the procedure by the surgeon) at the end of the surgery
Secondary Warm ischemia time Warm ischemia time Intra-operatively
Secondary 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
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