Prospective Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy
Patients should have the following characteristics:
- About 75 years, or
- Whatever the age:
- A context of family-type tumor (VHL, hereditary carcinoma, tubulo-papillary
- or solitary kidney, when the tumor is not easily accessible for nephron-sparing
surgery: Malignant centro-hilar or intra-parenchymal;
- or in a local recurrence (single or multiple) after partial nephrectomy (within
a limit of 3 tumors to be treated);
- or in a subject with impaired renal function and therefore at risk of severe
renal insufficiency (risk defined by a creatinine clearance below 30 ml / min by
- and who do not present any contra-indication for cryoablation treatment.
The tumor(s) should meet the following criteria:
- Presence of one to three solid tumors of the native renal parenchyma with a largest
diameter less than (or equal to) 40 mm, which corresponds to a maximum volume of
about 32 cc, as measured by MRI.
- A preoperative MRI is essential since this technique presents a higher sensitivity.
This control will also give more consistency to the evaluation of the radiological
semiology at follow-up.
- And its/their location(s) will be accessible to a percutaneous approach.
The search of metastases, including a thoracic CT scan, should be negative.
Exclusion Criter ia:
- - Partial nephrectomy feasible in good technical and oncologic conditions in patients
under 75 years and in the absence of family tumors.
- Contraindication to any form of sedation.
- Irreversible coagulopathy
- Tumor> 4cm
- Contraindication to MRI or gadolinium (proven allergy). NB: Patients with a
glomerular filtration rate below 30 ml/min/1, 73 m2 will be injected with a single
dose of the macrocyclic gadolinium with the highest thermodynamic stability (Dotarem
or Prohance), given the united recommendations of AFSSAPS and EMA (European Medicines
Agency) . On the contrary, the linear molecules of gadolinium, due to their
lower stability, will be contra-indicated because of the risk of systemic nephrogenic
- Recurrence on the same location after a procedure performed out of the thermoablation
- Biopsy proven benign tumor
- Predominantly cystic tumor, defined by a necrotic content constituting over one third
of tumor volume
- Presence of endo-venous extension, of proven secondary extensions, visceral or in the
lymph nodes (especially lung). In this regard, a thoracic CT scan will be routinely
required before treatment, according to the recommendations of urological societies.
- Psychiatric disorders and adults under guardianship
- Pregnancy or breastfeeding
- Minor patients
- Legal safeguard
- Participation in another clinical trial