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Radiofrequency versus Ethanol Ablation for Treating Predominantly Cystic Thyroid Nodules: A Randomized Clinical Trial

  • Baek, Jung Hwan (Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center) ;
  • Ha, Eun Ju (Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center) ;
  • Choi, Young Jun (Department of Radiology and Research Institute of Radiology, University of Ulsan College of Medicine, Asan Medical Center) ;
  • Sung, Jin Yong (Department of Radiology, Thyroid Center, Daerim St. Mary's Hospital) ;
  • Kim, Jae Kyun (Department of Radiology, Chung-Ang University College of Medicine) ;
  • Shong, Young Kee (Department of Endocrinology and Metabolism, University of Ulsan College of Medicine, Asan Medical Center)
  • Received : 2015.02.08
  • Accepted : 2015.07.21
  • Published : 2015.11.01

Abstract

Objective: To compare single-session radiofrequency ablation (RFA) and ethanol ablation (EA) for treating predominantly cystic thyroid nodules (PCTNs). Materials and Methods: This single-blind, randomized trial was approved by the Institutional Review Board of two centers and informed consent was obtained from all patients before enrollment. Fifty patients with a single PCTN (cystic portion less than 90% and greater than 50%) were randomly assigned to be treated by either RFA (25 patients) or EA (25 patients) at two hospitals. The primary outcome was the tumor volume reduction ratio (%) at the six-month follow-up and the superiority margin was set at 13% (RFA minus EA). Analysis was performed primarily in an intention-to-treat manner. The secondary outcomes were the therapeutic success rate, improvement of symptomatic and cosmetic problems, and the number of major complications. Results: The mean volume reduction was $87.5{\pm}11.5%$ for RFA (n = 22) and $82.4{\pm}28.6%$ for EA (n = 24) (p = 0.710; mean difference [95% confidence interval], 5.1% [-8.0 to 18.2]), indicating no significant difference. Regarding the secondary outcomes, therapeutic success (p = 0.490), mean symptom (p = 0.205) and cosmetic scores (p = 0.710) showed no difference. There were no major complications in either group (p > 0.99). Conclusion: The therapeutic efficacy of RFA is not superior to that of EA; therefore, EA might be preferable as the first-line treatment for PCTNs.

Keywords

References

  1. Kim YJ, Baek JH, Ha EJ, Lim HK, Lee JH, Sung JY, et al. Cystic versus predominantly cystic thyroid nodules: efficacy of ethanol ablation and analysis of related factors. Eur Radiol 2012;22:1573-1578 https://doi.org/10.1007/s00330-012-2406-5
  2. Lim HK, Lee JH, Ha EJ, Sung JY, Kim JK, Baek JH. Radiofrequency ablation of benign non-functioning thyroid nodules: 4-year follow-up results for 111 patients. Eur Radiol 2013;23:1044-1049 https://doi.org/10.1007/s00330-012-2671-3
  3. Kim DW, Rho MH, Park HJ, Kwag HJ. Ultrasonography-guided ethanol ablation of predominantly solid thyroid nodules: a preliminary study for factors that predict the outcome. Br J Radiol 2012;85:930-936 https://doi.org/10.1259/bjr/81849588
  4. Zingrillo M, Torlontano M, Chiarella R, Ghiggi MR, Nirchio V, Bisceglia M, et al. Percutaneous ethanol injection may be a definitive treatment for symptomatic thyroid cystic nodules not treatable by surgery: five-year follow-up study. Thyroid 1999;9:763-767 https://doi.org/10.1089/thy.1999.9.763
  5. Bennedbaek FN, Hegedus L. Treatment of recurrent thyroid cysts with ethanol: a randomized double-blind controlled trial. J Clin Endocrinol Metab 2003;88:5773-5777 https://doi.org/10.1210/jc.2003-031000
  6. Gharib H, Hegedüs L, Pacella CM, Baek JH, Papini E. Clinical review: nonsurgical, image-guided, minimally invasive therapy for thyroid nodules. J Clin Endocrinol Metab 2013;98:3949-3957 https://doi.org/10.1210/jc.2013-1806
  7. Papini E, Pacella CM, Misischi I, Guglielmi R, Bizzarri G, Dossing H, et al. The advent of ultrasound-guided ablation techniques in nodular thyroid disease: towards a patienttailored approach. Best Pract Res Clin Endocrinol Metab 2014;28:601-618 https://doi.org/10.1016/j.beem.2014.02.004
  8. Sung JY, Kim YS, Choi H, Lee JH, Baek JH. Optimum firstline treatment technique for benign cystic thyroid nodules: ethanol ablation or radiofrequency ablation? AJR Am J Roentgenol 2011;196:W210-W214 https://doi.org/10.2214/AJR.10.4258
  9. Sung JY, Baek JH, Kim KS, Lee D, Yoo H, Kim JK, et al. Single-session treatment of benign cystic thyroid nodules with ethanol versus radiofrequency ablation: a prospective randomized study. Radiology 2013;269:293-300 https://doi.org/10.1148/radiol.13122134
  10. Cho YS, Lee HK, Ahn IM, Lim SM, Kim DH, Choi CG, et al. Sonographically guided ethanol sclerotherapy for benign thyroid cysts: results in 22 patients. AJR Am J Roentgenol 2000;174:213-216 https://doi.org/10.2214/ajr.174.1.1740213
  11. Valcavi R, Frasoldati A. Ultrasound-guided percutaneous ethanol injection therapy in thyroid cystic nodules. Endocr Pract 2004;10:269-275 https://doi.org/10.4158/EP.10.3.269
  12. Jang SW, Baek JH, Kim JK, Sung JY, Choi H, Lim HK, et al. How to manage the patients with unsatisfactory results after ethanol ablation for thyroid nodules: role of radiofrequency ablation. Eur J Radiol 2012;81:905-910 https://doi.org/10.1016/j.ejrad.2011.02.039
  13. Lee JH, Kim YS, Lee D, Choi H, Yoo H, Baek JH. Radiofrequency ablation (RFA) of benign thyroid nodules in patients with incompletely resolved clinical problems after ethanol ablation (EA). World J Surg 2010;34:1488-1493 https://doi.org/10.1007/s00268-010-0565-6
  14. Na DG, Lee JH, Jung SL, Kim JH, Sung JY, Shin JH, et al. Radiofrequency ablation of benign thyroid nodules and recurrent thyroid cancers: consensus statement and recommendations. Korean J Radiol 2012;13:117-125 https://doi.org/10.3348/kjr.2012.13.2.117
  15. Kwak JY, Jung I, Baek JH, Baek SM, Choi N, Choi YJ, et al. Image reporting and characterization system for ultrasound features of thyroid nodules: multicentric Korean retrospective study. Korean J Radiol 2013;14:110-117 https://doi.org/10.3348/kjr.2013.14.1.110
  16. Lee YH, Baek JH, Jung SL, Kwak JY, Kim JH, Shin JH, et al. Ultrasound-guided fine needle aspiration of thyroid nodules: a consensus statement by the korean society of thyroid radiology. Korean J Radiol 2015;16:391-401 https://doi.org/10.3348/kjr.2015.16.2.391
  17. Yeon JS, Baek JH, Lim HK, Ha EJ, Kim JK, Song DE, et al. Thyroid nodules with initially nondiagnostic cytologic results: the role of core-needle biopsy. Radiology 2013;268:274-280 https://doi.org/10.1148/radiol.13122247
  18. Cibas ES, Ali SZ. The Bethesda System for Reporting Thyroid Cytopathology. Thyroid 2009;19:1159-1165 https://doi.org/10.1089/thy.2009.0274
  19. Jeong WK, Baek JH, Rhim H, Kim YS, Kwak MS, Jeong HJ, et al. Radiofrequency ablation of benign thyroid nodules: safety and imaging follow-up in 236 patients. Eur Radiol 2008;18:1244-1250 https://doi.org/10.1007/s00330-008-0880-6
  20. Huh JY, Baek JH, Choi H, Kim JK, Lee JH. Symptomatic benign thyroid nodules: efficacy of additional radiofrequency ablation treatment session--prospective randomized study. Radiology 2012;263:909-916 https://doi.org/10.1148/radiol.12111300
  21. Ha EJ, Baek JH, Lee JH. Moving-shot versus fixed electrode techniques for radiofrequency ablation: comparison in an exvivo bovine liver tissue model. Korean J Radiol 2014;15:836-843 https://doi.org/10.3348/kjr.2014.15.6.836
  22. Cesareo R, Pasqualini V, Simeoni C, Sacchi M, Saralli E, Campagna G, et al. Prospective study of effectiveness of ultrasound-guided radiofrequency ablation versus control group in patients affected by benign thyroid nodules. J Clin Endocrinol Metab 2015;100:460-466 https://doi.org/10.1210/jc.2014-2186
  23. Choi SH, Kim EK, Kim SJ, Kwak JY. Thyroid ultrasonography: pitfalls and techniques. Korean J Radiol 2014;15:267-276 https://doi.org/10.3348/kjr.2014.15.2.267
  24. Dossing H, Bennedbæk FN, Hegedus L. Interstitial laser photocoagulation (ILP) of benign cystic thyroid nodules-- a prospective randomized trial. J Clin Endocrinol Metab 2013;98:E1213-E1217 https://doi.org/10.1210/jc.2013-1503
  25. Lee SJ, Ahn IM. Effectiveness of percutaneous ethanol injection therapy in benign nodular and cystic thyroid diseases: long-term follow-up experience. Endocr J 2005;52:455-462 https://doi.org/10.1507/endocrj.52.455
  26. Bennedbaek FN, Nielsen LK, Hegedus L. Effect of percutaneous ethanol injection therapy versus suppressive doses of L-thyroxine on benign solitary solid cold thyroid nodules: a randomized trial. J Clin Endocrinol Metab 1998;83:830-835
  27. Dossing H, Bennedbaek FN, Hegedus L. Effect of ultrasoundguided interstitial laser photocoagulation on benign solitary solid cold thyroid nodules - a randomised study. Eur J Endocrinol 2005;152:341-345 https://doi.org/10.1530/eje.1.01865
  28. Hegedüs L, Karstrup S, Rasmussen N. Evidence of cyclic alterations of thyroid size during the menstrual cycle in healthy women. Am J Obstet Gynecol 1986;155:142-145 https://doi.org/10.1016/0002-9378(86)90098-0
  29. Burke DR, Lewis CA, Cardella JF, Citron SJ, Drooz AT, Haskal ZJ, et al. Quality improvement guidelines for percutaneous transhepatic cholangiography and biliary drainage. J Vasc Interv Radiol 2003;14(9 Pt 2):S243-S246
  30. Ha EJ, Baek JH, Kim KW, Pyo J, Lee JH, Baek SH, et al. Comparative efficacy of radiofrequency and laser ablation for the treatment of benign thyroid nodules: systematic review including traditional pooling and bayesian network metaanalysis. J Clin Endocrinol Metab 2015;100:1903-1911 https://doi.org/10.1210/jc.2014-4077
  31. Suh CH, Baek JH, Ha EJ, Choi YJ, Lee JH, Kim JK, et al. Ethanol ablation of predominantly cystic thyroid nodules: evaluation of recurrence rate and factors related to recurrence. Clin Radiol 2015;70:42-47 https://doi.org/10.1016/j.crad.2014.09.008
  32. Ji Hong M, Baek JH, Choi YJ, Lee JH, Lim HK, Shong YK, et al. Radiofrequency ablation is a thyroid function-preserving treatment for patients with bilateral benign thyroid nodules. J Vasc Interv Radiol 2015;26:55-61 https://doi.org/10.1016/j.jvir.2014.09.015
  33. Sung JY, Baek JH, Jung SL, Kim JH, Kim KS, Lee D, et al. Radiofrequency ablation for autonomously functioning thyroid nodules: a multicenter study. Thyroid 2015;25:112-117 https://doi.org/10.1089/thy.2014.0100
  34. Lim HK, Baek JH, Lee JH, Kim WB, Kim TY, Shong YK, et al. Efficacy and safety of radiofrequency ablation for treating locoregional recurrence from papillary thyroid cancer. Eur Radiol 2015;25:163-170 https://doi.org/10.1007/s00330-014-3405-5
  35. Lee SJ, Jung SL, Kim BS, Ahn KJ, Choi HS, Lim DJ, et al. Radiofrequency ablation to treat loco-regional recurrence of well-differentiated thyroid carcinoma. Korean J Radiol 2014;15:817-826 https://doi.org/10.3348/kjr.2014.15.6.817
  36. Ha EJ, Baek JH. Advances in nonsurgical treatment of benign thyroid nodules. Future Oncol 2014;10:1399-1405 https://doi.org/10.2217/fon.14.59
  37. Kim DW. Usefulness of two-stage ethanol ablation in the treatment of benign predominantly cystic thyroid nodules. Endocr Pract 2014;20:548-555 https://doi.org/10.4158/EP13458.OR
  38. Baek JH, Lee JH, Sung JY, Bae JI, Kim KT, Sim J, et al. Complications encountered in the treatment of benign thyroid nodules with US-guided radiofrequency ablation: a multicenter study. Radiology 2012;262:335-342 https://doi.org/10.1148/radiol.11110416
  39. Eng OS, Potdevin L, Davidov T, Lu SE, Chen C, Trooskin SZ. Does nodule size predict compressive symptoms in patients with thyroid nodules? Gland Surg 2014;3:232-236

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