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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Robot assisted partial nephrectomy with 3D image guidance

    Procedure/Surgery

    patient have a partial nephrectomy for renal complex tumor

Treatment groups

694 Participants
are divided into 2 treatment groups
Group A: conventional groupNo intervention 0 interventions
Group B: 3D IGRAPN GROUPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

TRIFECTA score

evaluating peri-operative outcome complications as well as oncological safety and long-term renal function preservation.

Time frame
1 month

Secondary outcomes

1

Recurrence free survival

Recurrence-free survival and Overall survival

Time frame
2 and 5 years
2

Overall survival

Overall Survival

Time frame
2 and 5 years
3

Number of Conversion to radical nephrectomy

Need to convert to radical nephrectomy for intra-operative reasons

Time frame
Intraopertively
4

rate of Off clamp or superselective ischemia

use of techniques without renal artery clamping

Time frame
Intraoperatively

Other outcomes

Sponsors and contacts

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