Thyroid Nodule Clinical Trial
Official title:
Thyroid Nodules Treated With Percutaneous Radiofrequency Thermal Ablation: a Comparative Study
Percutaneous radiofrequency thermal ablation (RTA) was reported as an effective tool for the management of thyroid nodules (TNs). This study aims to validate RTA as a valid approach for patients with compressive TNs for whom surgery is contraindicated or refused. Two groups of subjects with TNs (one group to treat with RTA and a matched untreated control group) will be evaluated in term of TN volume, thyroid hormones and clinical symptoms.
Thyroid nodules (TNs) are very common in the general population, with a prevalence of about
50% in subjects older than 60 years undergoing neck ultrasound examination.
The great majority of TNs are benign, but they can be responsible for pressure symptoms in
the neck and result in discomfort and decreased quality of life. Large compressive TNs may
result in life-threatening conditions because of the potential acute onset of respiratory
crisis. Percutaneous radiofrequency thermal ablation (RTA) is a minimally invasive procedure
which has been firstly develop to treat patients with liver cancer and has been then used to
treat both malignant and benign tumor nodules in many organs. RTA also represents a
promising new approach for the management of TNs.The current prospective comparative study
investigated the long-term effectiveness of RTA in patients with both toxic and non-toxic
compressive TNs.
Forty consecutive patients with TNs with pressure symptoms were prospectively enrolled in
this study. Patients were randomised as follows: 20 patients were treated with a single RTA
session (group A) and 20 patients did not receive any treatment and were only followed-up
(group B).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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