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Prospective Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy

18 Years
Open (Enrolling)
Renal Tumors Less Than 4 cm

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Trial Information

Prospective Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Suspicious contrast enhancement and progression in size of the cryolesion detected by MRI

Outcome Description:

The success of cryoablation will be declared if the control at 1 year shows no suspicious contrast enhancement (the suspicious character is defined by significant contrast uptake (>15%) and heterogeneous or nodular or crescent-shape contrast enhancement) and if the cryolesion is not progressing in size compared to early post-ablation control (M1).

Outcome Time Frame:

1 year

Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpitaux universitaires de Strasbourg


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

November 2011

Completion Date:

May 2014

Related Keywords:

  • Renal Tumors Less Than 4 cm
  • Kidney Neoplasms