Status:
COMPLETED
Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Renal Tumors Less Than 4 cm
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01471002
Start Date
November 1 2011
End Date
April 1 2016
Last Update
April 8 2016
Active Locations (1)
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1
Nouvel Hôpital Civil
Strasbourg, Alsace, France, 67091