Percutaneous Radiofrequency Thermal Ablation in Compressive Thyroid Nodules

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Thyroid Nodules Treated With Percutaneous Radiofrequency Thermal Ablation: a Comparative Study

Conditions
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Thyroid Nodule

Intervention / Treatment
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* Procedure: Percutaneous Radiofrequency Thermal Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years; benign thyroid nodules (TYR 2) solid or predominantly solid (colloid component < 30%) large (> 4.0 mL) thyroid nodules refusal and/or inefficacy of surgery and/or radioiodine therapy. Exclusion Criteria: pregnancy malignant or suspicious thyroid nodules.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 87 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 |
| --- | --- |
| Experimental: Group A: RTA<br>Percutaneous Radiofrequency Thermal Ablation (RTA). | Procedure: Percutaneous Radiofrequency Thermal Ablation<br>* Percutaneous Radiofrequency Thermal Ablation (RTA) by using a RITA© StarBurst Talon needle (RITA Medical Systems, Fremont, CA). RTA is performed in each patient at Time 0.<br>|
| No Intervention: Group B: untreated<br>No treatment, only follow-up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in TN volume | Evaluation of TN volume by using Ultrasonography. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy on TN-related neck symptoms | Evaluation of TN-related neck symptoms scored separately as follows: 0 (absent), 1 (moderate), and 2 (severe). The sum of the individual scores generates a final score (SYS score) ranging from 0 to 6. | From time to treatment until 12 months. Time point evaluations at 1, 3, 6, 12 months. | 
| Efficacy on TN hyperfunction | Evaluation of TN hyperfunction by measuring serum concentrations of TSH, free thyroxine (fT4), free triiodothyronine (fT3) in patients with toxic TNs. | Efficacy on TN-related neck symptoms Time Frame: (FDAAA) From time to treatment until 12 months. Time point evaluations at 1, 3, 6, 12 months. | 
| Safety | Assessment of local impairment (pain, oedema, skin damage). Assessment of thyroid dysfunction by measuring serum concentrations of fT3, fT4, TSH. Assessment of thyroid autoimmunity (anti-Thyroglobulin and anti-Thyroperoxidase antibodies). | At 1, 3, 6, 12 months after baseline. | 
| Change from baseline in TN volume | Evaluation of TN volume by using Ultrasonography | 1 month | 
| Change from baseline in TN volume | Evaluation of TN volume by using Ultrasonography | 3 months | 
| Change from baseline in TN volume | Evaluation of TN volume by using Ultrasonography | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid Nodule, Radiofrequency Thermal Ablation, Pressure symptoms, Hyperthyroidism