Renal Cancer Clinical Trial
— ACCURATEOfficial title:
A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial Nephrectomy for Renal Complex Tumor (UroCCR N°99)
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.
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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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University Hospital, Grenoble |
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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