A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial Nephrectomy for Renal Complex Tumor (UroCCR N°99)

Renal Cancer Clinical Trial

— ACCURATE  

Official title:

A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial Nephrectomy for Renal Complex Tumor (UroCCR N°99)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05572216
• Other study ID #: EssaiClinique_ACCURATE
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Kidney Neoplasms
• Renal Cancer
• Renal Tumor

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