Roberto Cesareo1, Claudio Maurizio Pacella2, Valerio Pasqualini3, Giuseppe Campagna4, Mario Iozzino2, Andrea Gallo5, Angelo Lauria Pantano6, Roberto Cianni7, Claudio Pedone8, Paolo Pozzilli9, Chiara Taffon10, Anna Crescenzi10, Silvia Manfrini9, Andrea Palermo9. 1. Unit of Metabolic Diseases, "S.M. Goretti" Hospital, Latina, Italy. 2. Department of Diagnostic Imaging and Interventional Radiology, Regina Apostolorum Hospital, Albano Laziale, Italy. 3. Department of Radiology and "S.M. Goretti" Hospital, Latina, Italy. 4. Department of Internal Medicine, "S.M. Goretti" Hospital, Latina, Italy. 5. Department of Sense Organs, Sapienza University of Rome, Rome, Italy. 6. Department of Internal Medicine, University Hospital Campus Bio-Medico, Rome, Italy. 7. Department of Interventional Radiology, S. Camillo Hospital, Rome, Italy. 8. Geriatric Unit, Campus Bio-Medico University, Rome, Italy. 9. Unit of Endocrinology and Diabetes, Campus Bio-Medico University, Rome, Italy. 10. Pathology Unit, University Hospital Campus Bio-Medico, Rome, Italy.
Abstract
Background: No direct prospective studies comparing laser ablation (LA) and radiofrequency ablation (RFA) for debulking benign non-functioning thyroid nodules (BNTNs) exist. We aimed at comparing the efficacy and safety of both techniques in patients with solid or predominantly solid BNTN. Methods: This six-month, single-use, randomized, open-label, parallel trial compared the following primary endpoints between the RFA and LA groups six months after treatment: (i) nodule volume reduction expressed as a percentage of nodule volume at baseline; (ii) proportion of nodules with more than 50% reduction (successful rate). We enrolled subjects with a solitary BNTN or dominant nodule characterized by pressure symptoms/cosmetic problems or patients without symptoms who experienced a volume increase >20% in one year. Nodules underwent core needle biopsy for diagnosis. Patients were randomly assigned (1:1) to receive LA or RFA. Safety was assessed in all randomly assigned participants. Results:Sixty patients were randomly assigned to receive either RFA or LA (1:1) between January 2016 and November 2018. Both groups were similar in basal nodule volume, thyroid function, histology, symptoms/cosmetic score, and procedure time. At six months, the nodule volume reduction was 64.3% (95% confidence interval, CI 57.5-71.2) in the RFA group and 53.2% ([CI 47.2-95.2]; p = 0.02) in the LA group. This effect was also confirmed in the linear regression model adjusted for age, baseline volume, and proportion of cellular component (LA vs. RFA percent change Delta = -12.8, p = 0.02). No significant difference was observed in success rate six months after treatment (RFA vs. LA: 86.7% vs. 66.7%, p = 0.13) or in thyrotropin level between the groups. Although improved, no significant difference was observed between RFA and LA for compressive symptoms (RFA: 2.13 vs. 3.9, p < 0 · 001; LA: 2.4 vs. 3.87, p < 0.001) and cosmetic score (RFA: 1.65 vs. 2.2, p < 0.001; LA: 1.85 vs. 2.2, p < 0.001). The adverse event rates (local pain, dysphonia, thyrotoxicosis, fever, hematoma) were 37% (n = 11) and 43% (n = 13) for RFA and LA, respectively, with no requirement for hospitalization. Conclusion: Although the success rate was similar in the RFA and LA groups, RFA achieved a significantly larger nodule volume reduction at six months.
RCT Entities:
Background: No direct prospective studies comparing laser ablation (LA) and radiofrequency ablation (RFA) for debulking benign non-functioning thyroid nodules (BNTNs) exist. We aimed at comparing the efficacy and safety of both techniques in patients with solid or predominantly solid BNTN. Methods: This six-month, single-use, randomized, open-label, parallel trial compared the following primary endpoints between the RFA and LA groups six months after treatment: (i) nodule volume reduction expressed as a percentage of nodule volume at baseline; (ii) proportion of nodules with more than 50% reduction (successful rate). We enrolled subjects with a solitary BNTN or dominant nodule characterized by pressure symptoms/cosmetic problems or patients without symptoms who experienced a volume increase >20% in one year. Nodules underwent core needle biopsy for diagnosis. Patients were randomly assigned (1:1) to receive LA or RFA. Safety was assessed in all randomly assigned participants. Results: Sixty patients were randomly assigned to receive either RFA or LA (1:1) between January 2016 and November 2018. Both groups were similar in basal nodule volume, thyroid function, histology, symptoms/cosmetic score, and procedure time. At six months, the nodule volume reduction was 64.3% (95% confidence interval, CI 57.5-71.2) in the RFA group and 53.2% ([CI 47.2-95.2]; p = 0.02) in the LA group. This effect was also confirmed in the linear regression model adjusted for age, baseline volume, and proportion of cellular component (LA vs. RFA percent change Delta = -12.8, p = 0.02). No significant difference was observed in success rate six months after treatment (RFA vs. LA: 86.7% vs. 66.7%, p = 0.13) or in thyrotropin level between the groups. Although improved, no significant difference was observed between RFA and LA for compressive symptoms (RFA: 2.13 vs. 3.9, p < 0 · 001; LA: 2.4 vs. 3.87, p < 0.001) and cosmetic score (RFA: 1.65 vs. 2.2, p < 0.001; LA: 1.85 vs. 2.2, p < 0.001). The adverse event rates (local pain, dysphonia, thyrotoxicosis, fever, hematoma) were 37% (n = 11) and 43% (n = 13) for RFA and LA, respectively, with no requirement for hospitalization. Conclusion: Although the success rate was similar in the RFA and LA groups, RFA achieved a significantly larger nodule volume reduction at six months.
Authors: Zhicheng Yao; Tao Wu; Bowen Zheng; Lei Tan; Yufan Lian; Bo Liu; Jie Ren Journal: Front Endocrinol (Lausanne) Date: 2020-10-07 Impact factor: 5.555