Departments of Radiology, Internal Medicine, and Pathology, Thyroid Center, Daerim St Mary's Hospital, Seoul, Korea; Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center, 86 Asanbyeongwon-Gil, Songpa-gu, Seoul 138-736, Korea.
Radiology. 2013 Oct;269(1):293-300. doi: 10.1148/radiol.13122134. Epub 2013 Apr 24.
To compare volume reduction of single-session ethanol ablation (EA) and radiofrequency (RF) ablation for cystic thyroid nodule treatment.
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.
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).
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.
比较单次乙醇消融（EA）和射频（RF）消融治疗甲状腺囊性结节的体积减少情况。
所有患者均签署了参与这项前瞻性机构审查委员会批准的研究的书面知情同意书。在 2010 年 5 月 6 日至 2011 年 8 月 8 日的这项单中心、非劣效性试验中，50 名患者，每个患者都有一个单一的甲状腺囊性结节，被随机分配到 EA（25 名患者；女性平均年龄为 45.7 岁，男性为 37.5 岁）或 RF 消融（25 名患者；女性平均年龄为 45.1 岁，男性为 43.7 岁）治疗。在 EA 或 RF 消融之前，抽吸内部液体。主要终点是 6 个月随访时的体积减少率（百分比）；选择的非劣效性边界为-8%（EA 减去 RF 消融）。次要终点包括治疗成功率、症状和美容问题的改善，以及主要并发症的数量。分析主要以意向治疗的方式进行。计算了治疗后 6 个月体积减少率的均值差异的单侧 95%置信区间（CI），以检验非劣效性。在预先设定的 EA 与 RF 消融的非劣效性的基础上，对 EA 与 RF 消融的优越性进行了后续比较，使用了结局差异的双侧 95%CI。
EA 组的平均体积减少率为 96.9%，RF 消融组为 93.3%（每组 n = 21）（差异为 3.6%；差异的单侧 95%CI 的下限为 1.2%），因此表明 EA 与 RF 消融相比具有非劣效性。结局差异的双侧 95%CI 为 0.7%至 6.5%，表明 EA 与 RF 消融相比具有显著的优越性。所有患者均表现出治疗成功（P >.99）。两组的平均症状和美容评分均无显著差异（P =.806 和 P =.682）。无重大并发症（P >.99）。
EA 可能是甲状腺囊性结节的一线治疗方法，其疗效与 RF 消融相当，但费用低于 RF 消融。
