To validate the efficacy and safety of the cool-tip ablation method for breast tumors smaller than 2 cm.
A prospective, phase II-III study, which will include a series of cases of 30 patients. The hospitals involved will be Bellvitge University Hospital and Hospital del Mar. Efficacy was evaluated according magnetic resonance image and biopsy of the breast 1 month after the procedure. Patients will be followed up over a 2-year period to assess cosmetic results, short and long-term complications and possible recurrences.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Radiofrequency ablation of the tumour in the surgery group, associated whith axillary surgery when applicable
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
MRI post-RFA
Magnetic Resonance Image after Radiofrequency ablation to confirmate complete disappearance of tumor contrast enhancement (residual mm).
Time frame: "1 month"
BAG post-RFA
Breast biopsy after Radiofrequency to confirmate absence of viable tumor tissue using NADH, CK18 and CK19 stainings (tumor viability scale: 0, \<25%, 25-50%, 50-75%, \> 75%).
Time frame: "1 month"
Adverse Effects
Adverse effects related to radiofrequency
Time frame: "1 month"
Quality
Breast-Q
Time frame: "1 month"
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