About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Robot assisted partial nephrectomy with 3D image guidance
Procedure/Surgerypatient have a partial nephrectomy for renal complex tumor
Treatment groups
Trial outcomes
Primary outcomes
TRIFECTA score
evaluating peri-operative outcome complications as well as oncological safety and long-term renal function preservation.
Secondary outcomes
Recurrence free survival
Recurrence-free survival and Overall survival
Overall survival
Overall Survival
Number of Conversion to radical nephrectomy
Need to convert to radical nephrectomy for intra-operative reasons
rate of Off clamp or superselective ischemia
use of techniques without renal artery clamping
Sponsors and contacts
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