Jin Yong Sung 1 , Jung Hwan Baek , Kyu Sun Kim , Ducky Lee , Hyunju Yoo , Jae Kyun Kim , Seong Ho Park Show Affiliations »
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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 . © RSNA, 2013.
RCT Entities: Population
Interventions
Outcomes
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. © RSNA, 2013.
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Year: 2013
PMID： 23616630 DOI： 10.1148/radiol.13122134
Source DB: PubMed Journal: Radiology ISSN： 0033-8419 Impact factor: 11.105