Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy
Renal Tumors Less Than 4 cm
Conditions: official terms
Kidney Neoplasms
Study Type
Study Phase
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Galil Medical patented 17G Cryoablation Needles
Type: Device
Overall Status
The main objective is to evaluate the oncologic efficacy of percutaneous cryoablation of renal tumors smaller than 4 cm in patients with renal cancer that cannot be offered a partial nephrectomy. The oncologic outcome will be assessed by the presence or absence of residue or recurrence during a follow-up by MRI performed the first 12 months (M1, M3, M6, M12).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

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 MDRD formula);

- 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) [45]. On the contrary, the linear molecules of gadolinium, due to their lower stability, will be contra-indicated because of the risk of systemic nephrogenic fibrosis (FNS).

- Recurrence on the same location after a procedure performed out of the thermoablation protocol.

- 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
Nouvel Hôpital Civil
Strasbourg, Alsace, France
Status: Recruiting
Contact: Afshin GANGI, PU-PH - 03 69 55 07 56 -
Start Date
November 2011
Completion Date
May 2014
University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Record processing date processed this data on July 28, 2015 page