Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma

Study Overview
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Brief Summary
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This is a single center prospective clinical trial with regard to efficacy and safety of radiofrequency ablation of papillary thyroid microcarcinoma.

Detailed Description
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For treatment of papillary thyroid microcarcinoma (PTMC), radiofrequency ablation (RFA) will be performed with the supine position and neck extended under ultrasonogrphic guidance. Before RFA, local anesthesia will be performed. RFA system including radiofrequency generator (VIVA RF system, STARmed, Goyang-si, Korea) and internally cooled electrode (star RF electrode, STARmed, Goyang-si, Korea) will be used. With regard to RFA procedure, moving shot technique and hydrodissection, if indicated, will be used. After RFA, follow-up will be performed using ultrasonography, serum thyroid function test, and questionnaire for quality of life by face-to-face interview at 2 months, 6, 12, 18, 24 months during the first 2 years after RFA, and yearly afterwards.

Official Title
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Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma: Safety and Efficacy

Conditions
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Papillary Thyroid Microcarcinoma, Thyroid Cancer

Intervention / Treatment
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* Procedure: RFA for PTMC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: who agrees to the consent form aged from 19 to 60 years old who has been diagnosed with Bethesda category V or VI by fine needle aspiration or needle biopsy whose thyroid cancer is 1 cm or smaller than 1 cm length who does not have lymph node or distant metastasis whose thyroid cancer does not have extrathyroidal extension in whom it seems technically possible to completely ablate thyroid cancer using RF Exclusion Criteria: who cannot routinely followed up according to the study schedule who has been with Bethesda category I, II, III, or IV by fine needle aspiration or needle biopsy. who has hyperthyroidism that requires treatment who has bleeding tendency multifocal papillary thyroid microcarcinoma who is pregnant

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 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: RFA for PTMC<br>Group who will undergo RFA after diagnosis of PTC | Procedure: RFA for PTMC<br>* Radiofequency ablation for papillary thyroid microcarcinoma will be performed using the system including radiofrequency generator and internally cooled electrode.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of tumor size | Maximal dimension (mm) of ablation zone on Ultrasonography | baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Metastasis | Cervical Lymph node metastasis on Ultrasonography or other distant metastasis | baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years | 
| Change of Quality of Life | Score on a Korean version of a thyroid-specific Quality-of-life Questionnaire Scale in Thyroid Cancer Patients | baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years | 
| Incidence of potential side effects from RFA | rate of patients who underwent potential side effects from RFA | baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thyroid Diseases, Radiofrequency Ablation