Percutaneous Laser Ablation in Benign Thyroid Nodules.Long Term Results

Study Overview
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Brief Summary
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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: 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; 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; to demonstrate reproducibility of results within different environments and under different operators; 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.

Official Title
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Multicentric Randomized Controlled Study of Percutaneous Laser Ablation Versus Follow Up in Benign Thyroid Nodules. Long Term Results

Conditions
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Thyroid Nodule

Intervention / Treatment
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* Procedure: Percutaneous Laser Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The presence of a single nodule or dominating nodule; A solid or mixed echo-structure with less than 20% fluid volume; A lesion volume between 5 and 18 ml (greatest diameter > 3.0 cm and <= 4 cm); Thyroid hormone and TSH serum levels within the normalcy value; 2 cytologically negative examinations for suspected neoplasia (British Thyroid Association, Second class THY)within the last six months; Calcitonin values within the normalacy value; Anticoagulant treatment suspension and antiaggregation treatment suspended for at least 72 hours. Exclusion Criteria: Hyperfunctioning lesion (99mTc scintigraph); Autoimmune thyreopathy or elevation of autoantibodies; Active anticoagulant treatment or antiaggregation treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Laser thermal ablation | Procedure: Percutaneous Laser Ablation<br>* Single session with standardized approach: Two fibers, up to 2 laser emissions; nodule volume up to 10 ml are treated by 800 Joules /ml and above 10 ml by 600 Joules/ml.The treatment is performed under local anesthesia and with diazepam sedation.<br>* Other names: (Asclepion Laser Technologies GmbH, Germany).;|
| No Intervention: 2<br>Follow-up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short- (1-year) and long- (3-year) term evolution of the thyroid nodules volume and symptoms after the treatment vs. simple clinical observation.(Strong Endpoint: %nodules with greater than 50% base volume reduction and %patients free of symptoms) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of short-term and long-term PLA safety, tolerability and reproducibility. |  | 3 years |