Single-session treatment of benign cystic thyroid nodules with ethanol versus radiofrequency ablation: a prospective randomized study.

Sung, Jin Yong; Baek, Jung Hwan; Kim, Kyu Sun; Lee, Ducky; Yoo, Hyunju; Kim, Jae Kyun; Park, Seong Ho
2013Oct ; 269 ( 1 ) :293-300.
저자 상세정보
Sung, Jin Yong -
Baek, Jung Hwan -
Kim, Kyu Sun -
Lee, Ducky -
Yoo, Hyunju -
Kim, Jae Kyun -
Park, Seong Ho -
PURPOSE: To compare volume reduction of single-session ethanol ablation (EA) and radiofrequency (RF) ablation for cystic thyroid nodule treatment. MATERIALS AND

METHODS: All patients gave written informed consent to participate in this prospective institutional review board-approved study. From May 6, 2010, to August 8, 2011, in this single-institutional, noninferiority trial, 50 patients, each with a single cystic thyroid nodule, were randomly assigned to EA (25 patients; mean age for women, 45.7 years, and for men, 37.5 years) or RF ablation (25 patients; mean age for women, 45.1 years, and for men, 43.7 years) treatment. Internal fluid was aspirated prior to EA or RF ablation. Primary end point was the volume reduction ratio (percentage) at 6-month follow-up; the noninferiority margin was chosen as -8% (EA minus RF ablation). Secondary end points included therapeutic success rate, improvement of symptoms and cosmetic problems, and number of major complications. Analysis was performed primarily in intention-to-treat manner. A one-sided 95% confidence interval (CI) for the mean difference in volume reduction ratio 6 months after treatment was calculated to test for noninferiority. Subsequent superiority comparison of EA with RF ablation on a condition of establishment of the noninferiority of EA to RF ablation was preplanned and used two-sided 95% CI of the outcome difference.

RESULTS: The mean volume reduction was 96.9% in EA and 93.3% in RF ablation (n = 21 for each) (difference, 3.6%; lower bound of the one-sided 95% CI of the difference, 1.2%), thus demonstrating the noninferiority of EA to RF ablation. Two-sided 95% CI of the outcome difference was 0.7% to 6.5%, demonstrating significant superiority of EA to RF ablation. All patients demonstrated therapeutic success (P > .99). Mean symptom and cosmetic scores showed no significant difference in either group (P = .806 and P = .682, respectively). There were no major complications (P > .99). CONCLUSION: EA may be the first-line treatment modality for cystic thyroid nodules, which has comparable therapeutic efficacy to, but is less expensive than, RF ablation. CI - ??RSNA, 2013.
Adult, Aged, Catheter Ablation/*methods, Cysts/*therapy/*ultrasonography, Ethanol/*administration & dosage, Female, Humans, Male, Middle Aged, Prospective Studies, Sclerosing Solutions/administration & dosage, Thyroid Nodule/*therapy/*ultrasonography, Treatment Outcome, Ultrasonography, Interventional/*methods

주제명(Target field)
연구참여(Sample size)
질병특성(Condition Category)
연구설계(Study Design)
중재방법(Intervention Type)
중재명칭(Intervention Name)
In regard to the secondary end points, all patients in both groups achieved therapeutic success in which there was no significant difference (P > .99). The mean symptom and cosmetic scores showed no significant difference in either group (P = .806 and P = .682, respectively).
연구비지원(Fund Source)
근거수준평가(Evidence Hierarchy)
ICD 03