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

Not Applicable

Recruiting

• Conditions: Renal Tumor; Renal Cancer
• Interventions: Procedure: Robot assisted partial nephrectomy with 3D image guidance

• Registration Number: NCT05572216
• Lead Sponsor: University Hospital, Grenoble

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-10-05
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-07
• Study Start: 2023-01-24
• Primary Completion: 2023-01-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Study Completion: 2027-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 694

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D IGRAPN GROUP	Robot assisted partial nephrectomy with 3D image guidance	Robot-Assisted Partial Nephrectomy with 3D navigation

Primary Outcome Measures

Name	Time	Method
TRIFECTA score	1 month	evaluating peri-operative outcome complications as well as oncological safety and long-term renal function preservation.

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 and 5 years	Overall Survival
Amount of parenchyma preserved (according to CT scan)	Month 6	Preservation of safe kidney
Blood loss	Intra-operatively	Blood loss
Warm ischemia time	Intra-operatively	Warm ischemia time
Recurrence free survival	2 and 5 years	Recurrence-free survival and Overall survival
Number of Conversion to radical nephrectomy	Intraopertively	Need to convert to radical nephrectomy for intra-operative reasons
rate of Off clamp or superselective ischemia	Intraoperatively	use of techniques without renal artery clamping
Medico-economic evaluation	Month 1 and 6	ncremental cost-utility ratio (ICUR) expressed as the extra cost per a QALY gained by the 3D-IGRAPN strategy compared to standard RAPN.
NASA TLX	at the end of the surgery	Ergonomy score (questionnaire completed at the end of the procedure by the surgeon)

Trial Locations

Locations (2)

University Hospital Grenoble; 🇫🇷 Grenoble, France

university HospitalGrenoble; 🇫🇷 Grenoble, France