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

NCT ID: NCT01471002

Last Updated: 2016-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2016-04-30

Brief Summary

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).

Conditions

Renal Tumors Less Than 4 cm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renal cancer without nephrectomy

patients with renal cancer that cannot be offered a partial nephrectomy

Group Type: EXPERIMENTAL

Galil Medical patented 17G Cryoablation Needles

Intervention Type: DEVICE

Interventions

Galil Medical patented 17G Cryoablation Needles

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Afshin GANGI, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

Nouvel Hôpital Civil

Strasbourg, Alsace, France

Countries

France

Other Identifiers

5062

Identifier Type: -

Identifier Source: org_study_id