The goal of this clinical trial is to demonstrate that TIR3A nodules with negative genetic test can be safely and effectively treated by radiofrequency ablation, with nodular shrinkage and improvement of clinical symptoms. Fine needle aspiration cytology is the gold standard test for differential diagnosis of thyroid nodules, but sometimes the result can be indeterminate with a risk of malignancy of 10-30%. In these cases the ablation is not indicated and many patients with benign nodules that may benefit from the procedure are not treated. All the patients enrolled must have a TIR3A cytology and negative genetic test for mutations associated with thyroid carcinoma. Before the ablation blood, evaluation of serum TSH, anti-thyroglobulin antibodies, anti-thyroid peroxidase antibodies and calcitonin levels will be performed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The ablation with radiofrequency is a safe and effective minimally invasive procedure that results in thermal tissue necrosis. A needle electrode is inserted into the thyroid nodule using ultrasound guidance and generates heat by alternating electric current causing thermal injury. Afterwards, the ablated tissue is gradually absorbed with progressive shrinkage of the nodule.
Istituto Auxologico Italiano IRCCS
Milan, Italy
RECRUITINGThyroid nodule volume reduction rate
The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
Time frame: 1 month after the procedure
Thyroid nodule volume reduction rate
The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
Time frame: 6 months after the procedure
Thyroid nodule volume reduction rate
The change rate of the thyroid nodule volume after radiofrequency ablation compared to baseline
Time frame: 12 months after the procedure
Complication rate
Assessment of the complications of the procedure and over time
Time frame: When the procedure is performed
Complication rate
Assessment of the complications of the procedure and over time
Time frame: 1 month after the procedure
Complication rate
Assessment of the complications of the procedure and over time
Time frame: 6 months after the procedure
Complication rate
Assessment of the complications of the procedure and over time
Time frame: 12 months after the procedure
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