Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma

Not Applicable

Recruiting

• Conditions: Papillary Thyroid Microcarcinoma; Thyroid Cancer
• Interventions: Procedure: RFA for PTMC

• Registration Number: NCT03432299
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-02-07
• Study First Posted: 2018-02-14
• Study Start: 2018-04-16
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26
• Primary Completion: 2023-07-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RFA for PTMC	RFA for PTMC	Group who will undergo RFA after diagnosis of PTC

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of