Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules

Study Overview
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Brief Summary
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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.

Detailed Description
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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 To evaluate whether LA and RFA cause a reduction ≥50% in the volume of thyroid nodules after 6 months and 1 year follow-up 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 To evaluate changes in thyroid function and thyroid autoimmunity after LA and RFA. 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.

Official Title
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Prospective Randomized Comparative Study of the Effectiveness and Safety of Ultrasound-guided Laser and Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules

Conditions
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Thyroid Nodule

Intervention / Treatment
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* Device: Percutaneous Laser Ablation
* Device: Percutaneous Radiofrequency Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Solitary thyroid nodule or dominating nodule which is well-identifiable in multinodular goiter. Compressive and /or cosmetic symptoms caused by thyroid nodule or increase in nodule volume >20% in 1 year even without symptoms A nodule volume ≥ 5 ml Solid nodule (uniformly compact or nearly completely solid, with a liquid component not exceeding 30%); Two thyroid biopsies resulted negative for malignancy Calcitonin levels within normal ranges Exclusion Criteria: Hyperfunctioning lesion as evaluated biochemically and/or by 99mTc scintigraphy Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: LA Arm<br>Percutaneous Laser Ablation | Device: Percutaneous Laser Ablation<br>* Single session with standardized approach: One or two fibers will be used for treatments including one to three illuminations with a fixed output power of 3 W, using the pullback technique. Energy for each emission will be 1200-1800J based on nodule volume. The treatment is performed under local anesthesia and conscious sedation.<br>|
| Active Comparator: RFA Arm<br>Percutaneous Radiofrequency Ablation | Device: Percutaneous Radiofrequency Ablation<br>* Single session with standardized approach: A radiofrequency generator and a 17-gauge, 15-cm electrode with a 1-cm active tip will be used. A transisthmic approach along the short axis of the nodule will be used and the nodules will be managed with the moving-shot technique. 60 W of radiofrequency outpower will be used for all nodules. The treatment is performed under local anesthesia and conscious sedation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of thyroid nodules with volume reduction at 6 and 12 months after treatment | Differences in the percentage of nodules with greater than 50% base volume reduction at 6 and 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basal Volume of Thyroid Nodules as Predictive factor of response to treatment | Basal volume in mL of the nodules will be calculated with the ellipsoid formula | 12 months | 
| Histopathological features of Thyroid Nodules as Predictive factor of response to treatment | % of amount of fibrosis and colloid components evaluated with score-biopsy | 12 months | 
| Variation in TSH levels after treatment | Variation in TSH value (mUI/ml) before and after LA and RFA | 12 months | 
| Variation in AbTPO and AbTg levels after treatment | Variation in AbTPO and AbTg levels (UI/ml) before and after LA and RFA | 12 months | 
| Complications | Differences in the rate of complications and side effects between LA and RFA | Up to 1 year follow-up | 
| Tolerability evaluated by McGill Pain Questionnaire | Tolerability will be evaluated by McGill Pain Questionnaire, Melzack 1975, italian version | 0 and 6 months | 
| Quality of Life | Quality of Life will be evaluated by SF-36 QoL questionnaire after 6 months and 1 year in both arms. | 6 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid Nodule, Percutaneous radiofrequency ablation (RFA), Percutaneous laser ablation (LA)