Thyroid Nodule Clinical Trial
Official title:
Prospective Randomized Comparative Study of the Effectiveness and Safety of Ultrasound-guided Laser and Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules
The purpose of this study is to prospectively compare percutaneous radiofrequency ablation (RFA) versus percutaneous laser ablation (LA) for the treatment of solid thyroid nodules.
Nodular thyroid disease is a common clinical problem whose prevalence increases with age and
with a more widespread use of thyroid ultrasonography. Although most thyroid nodules are
benign and need only periodic monitoring, some may require treatment for associated pressure
and/or cosmetic symptoms. Although thyroid surgery is the main therapeutic approach for
compressive thyroid nodules, it may be associated with several drawbacks. Long-term
levothyroxine suppression treatment in elderly patients with large nodular goiters is
unsatisfactory because it is ineffective. Furthermore, it is associated with adverse effects
on bones and the cardiovascular system. Nonsurgical, minimally invasive treatment modalities
such as percutaneous laser ablation (LA) and radiofrequency ablation (RFA) have been used to
treat thyroid nodules. However no studies comparing LA and RFA have been published so far.
Aims of the study
1. To evaluate whether LA and RFA cause a reduction ≥50% in the volume of thyroid nodules
after 6 months and 1 year follow-up
2. To evaluate whether the features of thyroid nodules as evaluated by thyroid ultrasound,
contrast-enhanced ultrasound, power-doppler and core-biopsy influence LA and RFA
outcomes
3. To evaluate changes in thyroid function and thyroid autoimmunity after LA and RFA.
4. To evaluate differences between LA and RFA in terms of complications, side effects and
tolerability.
Patients will be recruited, treated and followed at Santa Maria Goretti Hospital in Latina,
Italy, by physicians with expertise in LA and RFA. The scientific coordinator of this study
is dr. Silvia Manfrini.
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