Thyroid Nodule Clinical Trial
Official title:
Ultrasound-guided Percutaneous Microwave Ablation for Benign Thyroid Nodules
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Wenjun Wu | First Affiliated Hospital of Wenzhou Medical Univeristy |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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