Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules

Study Overview
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Brief Summary
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The purpose of the present protocol is to evaluate the response rate to treatment of these symptomatic benign nodules with radiofrequency as an alternative to surgical treatment. This thyroid nodules ablation with radiofrequency will be directed by a single percutaneous procedure guided by ultrasound. The procedure includes an ultrasound with percutaneously radiofrequency ablation of benign thyroid nodule. Clinical and ultrasonographic monitoring will last a year with consultations at 2 weeks (consultation only), 3 months, 6 months and 1 year (consultation, ultrasound TSH). The success of this procedure will be controlled with 3 successive ultrasounds the following year. The expected results are a decrease in the size of the nodule by at least 50% and a reduction in the functional and aesthetic discomfort, with less frequent complication than what is expected with surgery. The present study also intends to determine the medico economic impact of this technique compared to surgery.

Detailed Description
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Thyroid benign nodules represent a major public health problem because they are very common (subclinical nodules were found in half of woman beyond 60 years). The main risk factors include age, female gender, parity, smoking and family history of thyroid nodules or thyroiditis. The assessment is based on biology, ultrasound and fine needle aspiration and intends to determine the benign nature (95%) or cancer (5%) of the nodules and if they are functional or not (toxic nodule). Most benign nodules are asymptomatic but some of them because of their size and location can cause a functional disorder (compression or swallowing disorder) or aesthetic and psychological resounding.In current practice, these nodules are sometimes treated with surgery that impact on patient quality of life (need to take L-Thyroxine, difficulties related to the possible occurrence of complications like hypoparathyroidism or laryngeal paralysis) and socio-economic constraints especially when complications occur. To limit the number of unnecessary and potentially risky surgeries, patients should therefore be well selected. If surgery is the preferred treatment of thyroid cancer, alternative techniques like radiofrequency seem interesting for benign nodules.

Official Title
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Study of the Feasibility of Radiofrequency Ablation of Benign Thyroid Nodules by Percutaneous Radiological Approach

Conditions
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Benign Thyroid Nodules

Intervention / Treatment
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* Procedure: Radiofrequency ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Euthyroid or hypothyroidism properly substituted with normal TSH Benin nodule proved by FNA (Bethesda) and normal Calcitonin Nodule size> 1cm and / or increase in size Single nodule or asymptomatic nodules associated Symptomatic nodule with functional impairment and / or aesthetic Patient Agreement Patient with insurance coverage Written agreement for participation Exclusion Criteria: The exclusion criteria are related to the histological nature of the nodule and the necessary of the procedure: Allergy to local anesthetics FNA non-contributory or suspicious nodule (Bethesda) Multiple nodules more than 2cm Hyperthyroidism or hyperparathyroidism associated requiring surgical intervention. Taking a treatment with anticoagulant or double antiplatelet Patient with a Pacemaker Contralateral laryngeal paralysis in nodule Purely cystic nodule Nodule in contact with the recurrent nerve Patient Refusal Pregnant and breastfeeding women Patient trust, guardianship or safeguard justice.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with radiofrequency<br>Treatment of symptomatic benign nodules with radiofrequency ablation as an alternative to surgical treatment | Procedure: Radiofrequency ablation<br>* The procedure will include an ultrasound with radiofrequency ablation of the benign thyroid nodule percutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure response rate | First estimate of the procedure response rate (patient with complete procedure in percentage) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nodular volume | compared to the volume measured at inclusion. This reduction will be estimated in absolute value and in relative value (percentage reduction for a given subject) | at 6 and 12 months | 
| volume change of nodules by at least 50 percent, at 6 months | Percentage of patients with a volume decrease of at least 50 percent, 6 months after the procedure. Patients for which the procedure could not be fully performed will be counted among patients who have not had a reduction of at least 50 percent | at 6 months | 
| volume change of nodules by at least 50 percent, at 12 months | Percentage of patients with a volume decrease of at least 50 percent, 12 months after the procedure. Patients for which the procedure could not be fully performed will be counted among patients who have not had a reduction of at least 50 percent | at 12 months | 
| complete disappearance of symptoms | The symptoms will be evaluated by a visual analogue scale of 0 to 10 as proposed by the Korean consensus. The symptoms assessed will be: cervical pain, dysphagia, foreign body sensation, discomfort, coughing. | at 12 months | 
| aesthetic change | This improvement will be evaluated with a 4-level scale (no clinically detectable nodule 0, palpable nodule 1, visible nodule on swallowing 2, spontaneously visible nodule 3) as proposed by the Korean consensus. The improvement will be defined by the transition to the lower category. | at 3, 6 and 12 months | 
| one or more complications | In particular, the following will be investigated: signs of cutaneous involvement such as burns, hematoma and intra-nodular bleeding, recurrent paralysis, superinfections, tracheal or esophageal wounds. | at 6 and 12 months | 
| Assessment of pain during the procedure with visual analogue scale | Evaluation of the pain during the procedure using a visual analogue scale from 0 to 10 established at the end of the procedure | between Day 1 and Day 15 | 
| patients requiring L-thyroxine replacement therapy | Percentage of patients requiring L-thyroxine replacement therapy | at 6 and 12 months | 
| Economic evaluation from the point of view of the hospital | evaluation, from the point of view of the hospital, of the production cost of the new technique | Between Day 1 and 12 months | 
| patients who have used analgesics | Percentage of patients who have used analgesics during and after the procedure | between Day 1 and Day 15 | 
| Economic evaluation from the point of view of the health insurance | Evaluation, from the point of view of health insurance, of the cost of the care of patients who benefited from the new technique | Between Day 1 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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benign thyroid nodule, radiofrequency, symptomatic thyroid nodule