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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFA for PTMC | Experimental | Group who will undergo RFA after diagnosis of PTC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RFA for PTMC | Procedure | Radiofequency ablation for papillary thyroid microcarcinoma will be performed using the system including radiofrequency generator and internally cooled electrode. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji-hoon Kim, MD,Ph.D | Contact | +82-2-2072-3280 | jihnkim@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ji-hoon Kim, MD,Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39212950 | Derived | Lee JY, Na DG, Sim JS, Sung JY, Cho SW, Park DJ, Park YJ, Kim JH. A Prospective Clinical Trial of Radiofrequency Ablation in Patients with Low-Risk Unifocal Papillary Thyroid Microcarcinoma Favoring Active Surveillance Over Surgery. Thyroid. 2024 Sep;34(9):1126-1136. doi: 10.1089/thy.2024.0098. |
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| ID | Term |
|---|---|
| C563277 | Papillary Thyroid Microcarcinoma |
| D013964 | Thyroid Neoplasms |
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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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 |
| D004700 |
| Endocrine System Diseases |