Efficacy and Safety of Radiofrequency Ablation Versus Observation for Nonfunctioning Benign Thyroid Nodules: A Randomized Controlled International Collaborative Trial.

Deandrea, Maurilio; Sung, Jin Yong; Limone, Paolo; Mormile, Alberto; Garino, Francesca; Ragazzoni, Federico; Kim, Kyu Sun; Lee, Ducky; Baek, Jung Hwan
Thyroid : official journal of the American Thyroid Association
2015Aug ; 25 ( 8 ) :890-6.
저자 상세정보
Deandrea, Maurilio - 1 Endocrinology, Diabetes, and Metabolism Unit, A.O. Ordine Mauriziano di Torino, "Umberto I" Hospital , Turin, Italy .
Sung, Jin Yong - 2 Department of Radiology, Thyroid Center, Daerim St. Mary's Hospital , Seoul, Korea.
Limone, Paolo - 1 Endocrinology, Diabetes, and Metabolism Unit, A.O. Ordine Mauriziano di Torino, "Umberto I" Hospital , Turin, Italy .
Mormile, Alberto - 1 Endocrinology, Diabetes, and Metabolism Unit, A.O. Ordine Mauriziano di Torino, "Umberto I" Hospital , Turin, Italy .
Garino, Francesca - 1 Endocrinology, Diabetes, and Metabolism Unit, A.O. Ordine Mauriziano di Torino, "Umberto I" Hospital , Turin, Italy .
Ragazzoni, Federico - 1 Endocrinology, Diabetes, and Metabolism Unit, A.O. Ordine Mauriziano di Torino, "Umberto I" Hospital , Turin, Italy .
Kim, Kyu Sun - 2 Department of Radiology, Thyroid Center, Daerim St. Mary's Hospital , Seoul, Korea.
Lee, Ducky - 3 Department of Internal Medicine, Thyroid Center, Daerim St. Mary's Hospital , Seoul, Korea.
Baek, Jung Hwan - 4 Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine , Asan Medical Center, Seoul, Korea.
ABSTRACT
BACKGROUND: Percutaneous radiofrequency thermal ablation (RFA) has been reported as an effective tool for the management of benign thyroid nodules (BTN). However, large, randomized controlled trials (RCTs) are lacking. OBJECTIVE: The aims of this study were to assess the volume reduction of BTN after a single RFA performed using the moving-shot technique and to compare the volume reduction obtained in patients treated in two centers with different experience of the moving-shot technique. METHOD: This study was an international prospective RCT. It was carried out at the Mauriziano Hospital (Turin, Italy) and the Asan Medical Center (Seoul, Korea). Eighty patients harboring solid, compressive, nonfunctioning BTN (volume 10-20?mL) were enrolled. Twenty patients in each country were treated by RFA using a 18-Gauge internally cooled electrode (group A); 20 nontreated patients in each country were followed as controls (group B).

RESULTS: At six months, BTN volume significantly decreased in group A (15.1짹3.1?mL vs. 4.2짹2.7?mL; p<0.0001), whereas it remained unchanged in group B (14.4짹3.3?mL vs. 15.2짹3.5?mL). The baseline volume was larger in the Italian series (16.4짹2.5?mL vs. 13.9짹3.3?mL, p=0.009). However, at six months, there was no significant difference between the Korean group and the Italian group (3.7짹2.9?mL vs. 5.5짹2.2?mL). Both cosmetic and compressive symptoms significantly improved (3.6짹0.5 vs. 1.7짹0.4 and 3.6짹1.9 vs. 0.4짹0.7, respectively; p<0.001). No side effects occurred.

CONCLUSIONS: RFA was effective in reducing the volume of BTN. The outcome was similar in centers with different experience in the moving-shot technique.
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MESH
Adult, Aged, Aged, 80 and over, Biopsy, Catheter Ablation/*methods, Electrodes, Female, Humans, Italy, Male, Middle Aged, Patient Safety, Prospective Studies, Seoul, Thyroid Gland/ultrasonography, Thyroid Nodule/*diagnosis/*radiotherapy/ultrasonography, Treatment Outcome, Ultrasonography, Interventional
링크

주제코드
주제명(Target field)
연구대상(Population)
연구참여(Sample size)
대상성별(Gender)
질병특성(Condition Category)
연구환경(Setting)
연구설계(Study Design)
연구기간(Period)
중재방법(Intervention Type)
중재명칭(Intervention Name)
키워드(Keyword)
유효성결과(Recomendation)
Both cosmetic and compressive symptoms significantly improved (3.6±0.5 vs. 1.7±0.4 and 3.6±1.9 vs. 0.4±0.7, respectively; p<0.001). No side effects occurred.
연구비지원(Fund Source)
근거수준평가(Evidence Hierarchy)
출판년도(Year)
참여저자수(Authors)
대표저자
DOI
10.1089/thy.2015.0133.
KCD코드
ICD 03
건강보험코드