ECE2020 Oral Communications Endocrine-related Cancer (7 abstracts)
Llaser ablation vs radiofrequency ablation for benign non-functioning thyroid nodules: six-month results of a randomised, parallel, open-label, trial (LARA trial)
Roberto Cesareo 1 , Claudio Maurizio Pacella 2 , Valerio Pasqualini 3 , Giuseppe Campagna 4 , Angelo Lauria Pantano 5 , Paolo Pozzilli 6 , Roberto Cianni 7 , Silvia Manfrini 6 , Anna Crescenzi 8 & Andrea Palermo 9
1”SM Goretti” Hospital, Unit of metabolic diseases, Latina , Italy; 2Regina Apostolorum Hospital, Department of Diagnostic Imaging and Interventional Radiology, Italy; 3Department of Radiology, “SM Goretti” Hospital, Latina, Italy; 4 “SM Goretti” Hospital, Department of Internal Medicine, Latina, Italy; 5University Hospital Campus Bio-Medico, Rome, Italy, Department of Internal Medicine; 6Campus Bio-Medico University, Unit of Endocrinology and Diabetes, Rome, Italy; 7S Camillo Hospital, Department of Interventional Radiology, Rome, Italy; 8University Hospital Campus Bio-Medico, Pathology Unit, Rome, Italy; 9Campus Bio-Medico University, Unit of Endocrinology and Diabetes , Rome, Italy
Background: No direct prospective studies comparing laser ablation (LA) and radiofrequency ablation (RFA) for debulking benign non-functioning thyroid nodules (BNTNs) exist. We aimed to compare 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: (1) nodule volume reduction expressed as a percentage of nodule volume at baseline; (2) 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 (CNB) 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 57.5 – 71.2%) in the RFA group and 53.2% (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 6-month 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: While the success rate was similar in the RFA and LA groups, RFA achieved a significantly larger nodule volume reduction at six months.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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