Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules

Study Overview
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Brief Summary
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Percutaneous microwave ablation(MWA) was reported as an effective modality for the management of thyroid nodules(TNs). This study aims to validate MWA as a feasible approach for patients with TNs for whom surgery is contraindicated or refused. Two groups of subjects with TNs(one group to treat with MWA and the other group to receive regular ultrasonic follow-up without any treatment) will be evaluated in term of TN volume, ultrasonic image and clinical symptoms.

Official Title
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Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules

Conditions
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Thyroid Nodule

Intervention / Treatment
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* Device: Microwave Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age>18 years benign thyroid nodules(TYP 2) solid or predominantly solid(colloid component<30%)large (>3.0ml) thyroid nodules refusal and/or inefficacy of surgery Exclusion Criteria: pregnancy malignant or suspicious thyroid nodules

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>MWA Percutaneous Microwave Ablation intervention procedure: Ultrasound-guided Percutaneous Microwave Ablation | Device: Microwave Ablation<br>* Ultrasound-guided Percutaneous Microwave Ablation<br>* Other names: Ultrasound-guided Percutaneous Microwave Ablation;|
| No Intervention: Group B<br>untreated no treatment; regular ultrasonic image follow-up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the thyroid nodule volume assessed by ultrasonography after treatment vs simple clinical observation | Change of the thyroid nodule volume assessed by using ultrasonography, the volume reduction ratio(VRR) was calculated by the equation: VRR%=[(initial volume-final volume)*100]/initial volume | From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved score on TN-related symptoms | Evaluation of TN-related neck symptoms scored separately as follow:0(absent),1(moderate),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 | 
| Improved cosmetic grading score | Cosmetic problem evaluated by grading score(1,no palpable mass;2, no cosmetic problem but palpable mass; 3, a cosmetic problem on swallowing only; and 4, a readily detected cosmetic problem | From time to treatment until 12 months. Time point evaluations at 1,3,6,12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thyroid nodule, microwave ablation