Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma

Seoul National University Hospital100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Papillary Thyroid Microcarcinoma Thyroid Cancer

Interventions

RFA for PTMCPROCEDURE

Radiofequency ablation for papillary thyroid microcarcinoma will be performed using the system including radiofrequency generator and internally cooled electrode.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Change of tumor size

Maximal dimension (mm) of ablation zone on Ultrasonography

Time frame: baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years

Secondary Outcomes

Development of Metastasis

Cervical Lymph node metastasis on Ultrasonography or other distant metastasis

Time frame: 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

Time frame: 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

Time frame: baseline, 2, 6, 12, 18, 24 months during the first two years after RFA, and yearly afterwards upto 10 years

Central Contacts

Ji-hoon Kim, MD,Ph.D

CONTACT

+82-2-2072-3280 jihnkim@gmail.com

Data from ClinicalTrials.gov

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