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Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules: 12-Month Results of a Randomized Trial (LARA II Study)

Abstract Context Radiofrequency ablation (RFA) seems to achieve a significantly larger nodule volume reduction rate (VRR) than laser ablation (LA) in benign nonfunctioning thyroid nodules (BNTNs) Objective To compare the efficacy and safety of both treatments at 12-month follow-up in patients with s...

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Published in:The journal of clinical endocrinology and metabolism 2021-06, Vol.106 (6), p.1692-1701
Main Authors: Cesareo, Roberto, Manfrini, Silvia, Pasqualini, Valerio, Ambrogi, Cesare, Sanson, Gianfranco, Gallo, Andrea, Pozzilli, Paolo, Pedone, Claudio, Crescenzi, Anna, Palermo, Andrea
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creator Cesareo, Roberto
Manfrini, Silvia
Pasqualini, Valerio
Ambrogi, Cesare
Sanson, Gianfranco
Gallo, Andrea
Pozzilli, Paolo
Pedone, Claudio
Crescenzi, Anna
Palermo, Andrea
description Abstract Context Radiofrequency ablation (RFA) seems to achieve a significantly larger nodule volume reduction rate (VRR) than laser ablation (LA) in benign nonfunctioning thyroid nodules (BNTNs) Objective To compare the efficacy and safety of both treatments at 12-month follow-up in patients with solid or predominantly solid BNTN. Methods This was a single-center, 12-month, randomized, superiority, open-label, parallel-group trial conducted in an outpatient clinic. Sixty patients with a solitary BNTN or dominant nodule characterized by pressure symptoms/cosmetic problems were randomly assigned (1:1 ratio) to receive either a single session of RFA or LA. Twenty-9 patients per group completed the study. The main outcome measures were VRR and proportion of nodules with more than 50% reduction (technical success rate). Results At 12 months, VRR was 70.9 ± 16.9% and 60.0 ± 19.0% in the RFA and LA groups, respectively (P = .024). This effect was confirmed in the linear regression model that was adjusted for age, sex, nodule baseline volume, and proportion of cellular components (RFA treatment: β = .390; P = .009). No significant between-group difference was observed in the technical success rate at 12 months after treatment. A statistically significant improvement was observed from the baseline to the 12-month follow-up for compression (RFA: 4.6 ± 2.6 and 1.3 ± 0.8, P 
doi_str_mv 10.1210/clinem/dgab102
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Methods This was a single-center, 12-month, randomized, superiority, open-label, parallel-group trial conducted in an outpatient clinic. Sixty patients with a solitary BNTN or dominant nodule characterized by pressure symptoms/cosmetic problems were randomly assigned (1:1 ratio) to receive either a single session of RFA or LA. Twenty-9 patients per group completed the study. The main outcome measures were VRR and proportion of nodules with more than 50% reduction (technical success rate). Results At 12 months, VRR was 70.9 ± 16.9% and 60.0 ± 19.0% in the RFA and LA groups, respectively (P = .024). This effect was confirmed in the linear regression model that was adjusted for age, sex, nodule baseline volume, and proportion of cellular components (RFA treatment: β = .390; P = .009). No significant between-group difference was observed in the technical success rate at 12 months after treatment. A statistically significant improvement was observed from the baseline to the 12-month follow-up for compression (RFA: 4.6 ± 2.6 and 1.3 ± 0.8, P &lt; .001; and LA: 4.6 ± 2.1 and 1.6 ± 0.8, respectively, P &lt; .001) and cosmetic (RFA: 3.4 ± 0.6 and 1.3 ± 0.5, P &lt; .001; and LA: 3.4 ± 0.5 and 1.4 ± 0.6, P &lt; .001) scores although the between-group differences were not significant. Conclusion RFA achieved a significantly larger nodule volume reduction at 12 months; however, the technical success rate was similar in the RFA and LA groups.</description><identifier>ISSN: 0021-972X</identifier><identifier>EISSN: 1945-7197</identifier><identifier>DOI: 10.1210/clinem/dgab102</identifier><identifier>PMID: 33608728</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Ablation ; Ablation (Surgery) ; Analysis ; Care and treatment ; Clinics ; Nodules ; Radiofrequency ablation ; Statistical analysis ; Success ; Thyroid ; Thyroid diseases ; Thyroid gland</subject><ispartof>The journal of clinical endocrinology and metabolism, 2021-06, Vol.106 (6), p.1692-1701</ispartof><rights>The Author(s) 2021. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com 2021</rights><rights>The Author(s) 2021. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.</rights><rights>COPYRIGHT 2021 Oxford University Press</rights><rights>The Author(s) 2021. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c464t-7347b456cbbb26d17334e423563bbb3b8f5f6e9c875a39af7338079c98c1647a3</citedby><cites>FETCH-LOGICAL-c464t-7347b456cbbb26d17334e423563bbb3b8f5f6e9c875a39af7338079c98c1647a3</cites><orcidid>0000-0002-1143-4926 ; 0000-0001-5090-636X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33608728$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Cesareo, Roberto</creatorcontrib><creatorcontrib>Manfrini, Silvia</creatorcontrib><creatorcontrib>Pasqualini, Valerio</creatorcontrib><creatorcontrib>Ambrogi, Cesare</creatorcontrib><creatorcontrib>Sanson, Gianfranco</creatorcontrib><creatorcontrib>Gallo, Andrea</creatorcontrib><creatorcontrib>Pozzilli, Paolo</creatorcontrib><creatorcontrib>Pedone, Claudio</creatorcontrib><creatorcontrib>Crescenzi, Anna</creatorcontrib><creatorcontrib>Palermo, Andrea</creatorcontrib><title>Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules: 12-Month Results of a Randomized Trial (LARA II Study)</title><title>The journal of clinical endocrinology and metabolism</title><addtitle>J Clin Endocrinol Metab</addtitle><description>Abstract Context Radiofrequency ablation (RFA) seems to achieve a significantly larger nodule volume reduction rate (VRR) than laser ablation (LA) in benign nonfunctioning thyroid nodules (BNTNs) Objective To compare the efficacy and safety of both treatments at 12-month follow-up in patients with solid or predominantly solid BNTN. Methods This was a single-center, 12-month, randomized, superiority, open-label, parallel-group trial conducted in an outpatient clinic. Sixty patients with a solitary BNTN or dominant nodule characterized by pressure symptoms/cosmetic problems were randomly assigned (1:1 ratio) to receive either a single session of RFA or LA. Twenty-9 patients per group completed the study. The main outcome measures were VRR and proportion of nodules with more than 50% reduction (technical success rate). Results At 12 months, VRR was 70.9 ± 16.9% and 60.0 ± 19.0% in the RFA and LA groups, respectively (P = .024). This effect was confirmed in the linear regression model that was adjusted for age, sex, nodule baseline volume, and proportion of cellular components (RFA treatment: β = .390; P = .009). No significant between-group difference was observed in the technical success rate at 12 months after treatment. A statistically significant improvement was observed from the baseline to the 12-month follow-up for compression (RFA: 4.6 ± 2.6 and 1.3 ± 0.8, P &lt; .001; and LA: 4.6 ± 2.1 and 1.6 ± 0.8, respectively, P &lt; .001) and cosmetic (RFA: 3.4 ± 0.6 and 1.3 ± 0.5, P &lt; .001; and LA: 3.4 ± 0.5 and 1.4 ± 0.6, P &lt; .001) scores although the between-group differences were not significant. Conclusion RFA achieved a significantly larger nodule volume reduction at 12 months; however, the technical success rate was similar in the RFA and LA groups.</description><subject>Ablation</subject><subject>Ablation (Surgery)</subject><subject>Analysis</subject><subject>Care and treatment</subject><subject>Clinics</subject><subject>Nodules</subject><subject>Radiofrequency ablation</subject><subject>Statistical analysis</subject><subject>Success</subject><subject>Thyroid</subject><subject>Thyroid diseases</subject><subject>Thyroid gland</subject><issn>0021-972X</issn><issn>1945-7197</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNqFkUtr3DAURkVpaKZpt10WQTfJwoletqzuTGibgUkL02npTsh6JAq2NZHshfvrq2EmCZRA0EJw77mHK30AfMDoHBOMLnTnB9tfmBvVYkRegQUWrCw4Fvw1WCBEcCE4-XMM3qZ0hxBmrKRvwDGlFao5qRdgXqlkI2zaTo0-DPC3jWlKcK2MDy7a-8kOen5quxDh5naOwRv4PZips-kzxKS4DsN4C9c2Td2YYHBQZcVgQu__WgM30asOnq6adQOXS_hznMx89g4cOdUl-_5wn4BfX79sLq-K1Y9vy8tmVWhWsbHglPGWlZVu25ZUBnNKmWWElhXNFdrWrnSVFbrmpaJCudyvERda1BpXjCt6Ak733m0M-TlplL1P2nadGmyYkiRM7P6sLmlGP_2H3oUpDnk7SURZYYpKQp6oG9VZ6QcXxqj0TiobjrKOCiEydf4MlY-xvddhsM7n-nMDOoaUonVyG32v4iwxkrus5T5recg6D3w8bDu1vTWP-EO4GTjbA2HaviT7BywysbA</recordid><startdate>20210601</startdate><enddate>20210601</enddate><creator>Cesareo, Roberto</creator><creator>Manfrini, Silvia</creator><creator>Pasqualini, Valerio</creator><creator>Ambrogi, Cesare</creator><creator>Sanson, Gianfranco</creator><creator>Gallo, Andrea</creator><creator>Pozzilli, Paolo</creator><creator>Pedone, Claudio</creator><creator>Crescenzi, Anna</creator><creator>Palermo, Andrea</creator><general>Oxford University Press</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>7T5</scope><scope>7TM</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-1143-4926</orcidid><orcidid>https://orcid.org/0000-0001-5090-636X</orcidid></search><sort><creationdate>20210601</creationdate><title>Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules: 12-Month Results of a Randomized Trial (LARA II Study)</title><author>Cesareo, Roberto ; Manfrini, Silvia ; Pasqualini, Valerio ; Ambrogi, Cesare ; Sanson, Gianfranco ; Gallo, Andrea ; Pozzilli, Paolo ; Pedone, Claudio ; Crescenzi, Anna ; Palermo, Andrea</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c464t-7347b456cbbb26d17334e423563bbb3b8f5f6e9c875a39af7338079c98c1647a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Ablation</topic><topic>Ablation (Surgery)</topic><topic>Analysis</topic><topic>Care and treatment</topic><topic>Clinics</topic><topic>Nodules</topic><topic>Radiofrequency ablation</topic><topic>Statistical analysis</topic><topic>Success</topic><topic>Thyroid</topic><topic>Thyroid diseases</topic><topic>Thyroid gland</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Cesareo, Roberto</creatorcontrib><creatorcontrib>Manfrini, Silvia</creatorcontrib><creatorcontrib>Pasqualini, Valerio</creatorcontrib><creatorcontrib>Ambrogi, Cesare</creatorcontrib><creatorcontrib>Sanson, Gianfranco</creatorcontrib><creatorcontrib>Gallo, Andrea</creatorcontrib><creatorcontrib>Pozzilli, Paolo</creatorcontrib><creatorcontrib>Pedone, Claudio</creatorcontrib><creatorcontrib>Crescenzi, Anna</creatorcontrib><creatorcontrib>Palermo, Andrea</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium &amp; Calcified Tissue Abstracts</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>The journal of clinical endocrinology and metabolism</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Cesareo, Roberto</au><au>Manfrini, Silvia</au><au>Pasqualini, Valerio</au><au>Ambrogi, Cesare</au><au>Sanson, Gianfranco</au><au>Gallo, Andrea</au><au>Pozzilli, Paolo</au><au>Pedone, Claudio</au><au>Crescenzi, Anna</au><au>Palermo, Andrea</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules: 12-Month Results of a Randomized Trial (LARA II Study)</atitle><jtitle>The journal of clinical endocrinology and metabolism</jtitle><addtitle>J Clin Endocrinol Metab</addtitle><date>2021-06-01</date><risdate>2021</risdate><volume>106</volume><issue>6</issue><spage>1692</spage><epage>1701</epage><pages>1692-1701</pages><issn>0021-972X</issn><eissn>1945-7197</eissn><abstract>Abstract Context Radiofrequency ablation (RFA) seems to achieve a significantly larger nodule volume reduction rate (VRR) than laser ablation (LA) in benign nonfunctioning thyroid nodules (BNTNs) Objective To compare the efficacy and safety of both treatments at 12-month follow-up in patients with solid or predominantly solid BNTN. Methods This was a single-center, 12-month, randomized, superiority, open-label, parallel-group trial conducted in an outpatient clinic. Sixty patients with a solitary BNTN or dominant nodule characterized by pressure symptoms/cosmetic problems were randomly assigned (1:1 ratio) to receive either a single session of RFA or LA. Twenty-9 patients per group completed the study. The main outcome measures were VRR and proportion of nodules with more than 50% reduction (technical success rate). Results At 12 months, VRR was 70.9 ± 16.9% and 60.0 ± 19.0% in the RFA and LA groups, respectively (P = .024). This effect was confirmed in the linear regression model that was adjusted for age, sex, nodule baseline volume, and proportion of cellular components (RFA treatment: β = .390; P = .009). No significant between-group difference was observed in the technical success rate at 12 months after treatment. A statistically significant improvement was observed from the baseline to the 12-month follow-up for compression (RFA: 4.6 ± 2.6 and 1.3 ± 0.8, P &lt; .001; and LA: 4.6 ± 2.1 and 1.6 ± 0.8, respectively, P &lt; .001) and cosmetic (RFA: 3.4 ± 0.6 and 1.3 ± 0.5, P &lt; .001; and LA: 3.4 ± 0.5 and 1.4 ± 0.6, P &lt; .001) scores although the between-group differences were not significant. Conclusion RFA achieved a significantly larger nodule volume reduction at 12 months; however, the technical success rate was similar in the RFA and LA groups.</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>33608728</pmid><doi>10.1210/clinem/dgab102</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-1143-4926</orcidid><orcidid>https://orcid.org/0000-0001-5090-636X</orcidid><oa>free_for_read</oa></addata></record>
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1945-7197
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source Oxford Journals Online
subjects Ablation
Ablation (Surgery)
Analysis
Care and treatment
Clinics
Nodules
Radiofrequency ablation
Statistical analysis
Success
Thyroid
Thyroid diseases
Thyroid gland
title Laser Ablation Versus Radiofrequency Ablation for Thyroid Nodules: 12-Month Results of a Randomized Trial (LARA II Study)
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