Thyroid Nodule Clinical Trial
Official title:
Multicentric Randomized Controlled Study of Percutaneous Laser Ablation Versus Follow Up in Benign Thyroid Nodules. Long Term Results
Thyroid nodule pathologies occur frequently and represent a clinical issue for the
endocrinologists, surgeons, nuclear physicians as well as the general practitioners. The
incidence of this pathology has been further highlighted by the introduction of the
ultrasound examination into the clinical practice as 20% with impalpable thyroid nodules is
now detected through ultrasound. The majority of nodules are benign and characterized by
slow growth, and therefore treated with suppressive doses of levothyroxine. Long-term
levothyroxine treatment has, however, several well-known side effects and limitations.
During the last years, number of controlled studies have demonstrated that ultrasound guided
percutaneous laser treatment (PLA) is able to reach the target lesion within the thyroid
with a high level of precision, and to destroy the thyroid tissue in a predictable and
repeatable fashion, without side effects.
Aim of the study:
1. to assess 1-year and 3-year effect of laser ablation therapy on the volume of benign
thyroid nodules and on nodule-related symptoms, and to compare these effects with
findings in control group without active therapy;
2. to assess the eventual re-occurence of thyroid lesions (observed after other types of
ablation treatment, like percutaneous ethanol injection) during a 3-year follow-up;
3. to demonstrate reproducibility of results within different environments and under
different operators;
4. to validate eventual presence of major or minor side effects.
To this aim we shall randomized 200 patients either for PLA (100 pts) or standard follow-up.
Patients will be recruited, treated and followed in 4 italian centers (Ospedale Regina
Apostolorum - Roma, Arcispedale S. Maria Nuova - Reggio Emilia, Ospedale S. Maria della
Misericordia - Perugia, Ospedale di Cisanello - Pisa) by physicians with experience in
PLA.The scientific coordinator of this multicentre study is dr. Claudio Maurizio Pacella.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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