Clinical trial NCT03432299: Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma
Official title: Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma: Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Papillary Thyroid Microcarcinoma
Thyroid Cancer
Keywords: Thyroid Diseases
Radiofrequency Ablation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-02-14
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of tumor size
timeFrame: baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
Secondary outcomes:
measure: Development of Metastasis
timeFrame: baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
measure: Change of Quality of Life
timeFrame: baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
measure: Incidence of potential side effects from RFA
timeFrame: baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Ji-hoon Kim, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: