Radiofrequency Ablation of Low Risk Papillary Thyroid Microcarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-16

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Papillary Thyroid Microcarcinoma Thyroid Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RFA for PTMC

Group who will undergo RFA after diagnosis of PTC

Group Type EXPERIMENTAL

RFA for PTMC

Intervention Type PROCEDURE

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

Interventions

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RFA for PTMC

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No