Papillary Thyroid Microcarcinoma, Thyroid Cancer
Conditions
Keywords
Thyroid Diseases, Radiofrequency Ablation
Brief summary
This is a single center prospective clinical trial with regard to efficacy and safety of radiofrequency ablation of papillary thyroid microcarcinoma.
Detailed description
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.
Interventions
PROCEDURERFA for PTMC
Radiofequency ablation for papillary thyroid microcarcinoma will be performed using the system including radiofrequency generator and internally cooled electrode.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of tumor size | baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years | Maximal dimension (mm) of ablation zone on Ultrasonography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of Metastasis | baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years | Cervical Lymph node metastasis on Ultrasonography or other distant metastasis |
| Change of Quality of Life | baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years | Score on a Korean version of a thyroid-specific Quality-of-life Questionnaire Scale in Thyroid Cancer Patients |
| Incidence of 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 | rate of patients who underwent potential side effects from RFA |
Countries
South Korea
Contacts
Primary ContactJi-hoon Kim, MD,Ph.D
Outcome results
None listed