Thyroid Cancer Clinical Trial
Official title:
A Multicenter Prospective Controlled Trial of Laser Ablation Versus Surgery for the Treatment of Papillary Thyroid Microcarcinoma
This is a multicenter prospective controlled trial of percutaneous laser ablation(PLA) versus conventional surgery for the treatment of papillary thyroid microcarcinoma (PTMC).
PLA is the acronym for "Percutaneous Laser Ablation". The treatment consists in the destruction (ablation) of Papillary Thyroid Micro Carcinoma by means of optical fibers that deliver high-energy light (laser) into the lesion through skin puncturing (percutaneous). The procedure is performed under ultrasound imaging guidance (ultrasound-guided). The destruction of the lesion occurs through overheating and coagulation. PLA, however, still needs a large-scale validation trial in order to be considered as an effective alternative to both surgery or follow-up for low-risk PTMC in elderly patients and/or in patients with co-morbidities that might expose the patients to a high surgical risk. After a comprehensive information, patients will be consecutively assigned to Group 1 (surgery, preferentially lobectomy) or to Group 2 (percutaneous laser ablation, performed according to the attached procedure).Peri and post-operative complications, need of drug treatment, length of hospital admission and customer satisfaction will be registered. The aims of this study are as follows: 1.To establish the rate of cure or partial ablation; 2.To compare the complication rate, time expenditure and costs of two procedures; 3.To assess changes in thyroid function and the need of substitution therapy with two procedures; 4.To assess the tolerability of the procedure, the customer satisfaction and the impact on the quality of life of the patients between conventional surgery and PLA. ;
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