UnknownNot Applicable

RFA (Radiofrequency Ablation) Versus EA (Ethanol Ablation) for Predominantly Cystic Thyroid Nodules

South Korea50 participantsStarted 2013-02

Plain-language summary

Ultrasound-guided ethanol ablation is an effective treatment modality for patients with cystic thyroid nodules (cystic portion \> 90%); however it is less effective in predominantly cystic thyroid nodules (90% \> cystic portions \> 50%). The volume reduction after EA has been reported 64% - 69.8% for predominantly cystic thyroid nodules. EA is insufficient for 26% (27/103) of patients with predominantly cystic thyroid nodules. Radiofrequency ablation to patients with incompletely resolved clinical problems after EA and the mean volume reduction ratio was 92% at 6-month follow-up. It is well known that RF ablation is effective in both predominantly cystic and solid thyroid nodules. Although RF ablation has effectively treated the patients who were unsatisfactory after EA, to the best of our knowledge, no study to date has compared these two ablation techniques. Therefore investigators performed a prospective randomized study to compare single-session RF ablation and EA for treating predominantly cystic thyroid nodules.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patients with predominantly cystic thyroid nodules (90% \> cystic portion \> 50%) * reports of pressure symptoms or cosmetic problems * cytologic confirmation of benignancy in at least two, separate US-guided, fine-needle aspiration cytology or core needle biopsy for cystic fluid and/or a mural, solid component * serum levels of thyroid hormone, thyrotropin, and calcitonin within normal limits. Exclusion Criteria: * nodules showing malignant features, i.e. taller than wide, spiculated margin, markedly hypoechoic, micro- or macrocalcifications, on US * lack of informed consent * less than 20 years old * pregnant woman

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

quantitative volume reduction ratio of a thyroid lesion at six months following compared with before the ablation treatment

Timeframe: at six months following compared with before the ablation treatment

Trial details

NCT IDNCT01778400

SponsorAsan Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-05

View on ClinicalTrials.gov More Thyroid Nodule trials