RecruitingNot ApplicableNCT05572216

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


Sponsor

University Hospital, Grenoble

Enrollment

694 participants

Start Date

Jan 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria4

  • 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)

Interventions

PROCEDURERobot assisted partial nephrectomy with 3D image guidance

patient have a partial nephrectomy for renal complex tumor


Locations(2)

University Hospital Grenoble

Grenoble, France

university HospitalGrenoble

Grenoble, France

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NCT05572216


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