Diagnostic performance of ultrasound vs. ultrasound-guided FNAc in thyroid nodules: data from the ElaTION trial

ElaTION is a large multi-centre pragmatic randomised controlled trial, performed in 18 secondary/tertiary hospitals across England, comparing elastography ultrasound-guided fine needle aspiration cytology (EUS-FNAC) with ultrasound-guided FNAC (US-FNAC) alone in the diagnostic assessment of thyroid...

Full description

Saved in:
Bibliographic Details
Published in:The journal of clinical endocrinology and metabolism 2024-10
Main Authors: Mehanna, Hisham, Nankivell, Paul, Boelaert, Kristien, Woolley, Rebecca, Sharma, Neil, Sidhu, Paul S, Madani, Gitta, Da Forno, Philip, Moreman, Catherine, Palmer, Andrew, Fulton-Lieuw, Tessa, Taylor, Judith, Rajaguru, Kanchana, Bekker, Jasper, Vaidhyanath, Ram, Rehman, Thaj, Deeks, Jon
Format: Article
Language:English
Citations: Items that this one cites
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
cited_by
cites cdi_FETCH-LOGICAL-c220t-8bd0dd750945f90b56dc0517e194a50936f4bfb260eeb5af6d5c2640af0d332a3
container_end_page
container_issue
container_start_page
container_title The journal of clinical endocrinology and metabolism
container_volume
creator Mehanna, Hisham
Nankivell, Paul
Boelaert, Kristien
Woolley, Rebecca
Sharma, Neil
Sidhu, Paul S
Madani, Gitta
Da Forno, Philip
Moreman, Catherine
Palmer, Andrew
Fulton-Lieuw, Tessa
Taylor, Judith
Rajaguru, Kanchana
Bekker, Jasper
Vaidhyanath, Ram
Rehman, Thaj
Deeks, Jon
description ElaTION is a large multi-centre pragmatic randomised controlled trial, performed in 18 secondary/tertiary hospitals across England, comparing elastography ultrasound-guided fine needle aspiration cytology (EUS-FNAC) with ultrasound-guided FNAC (US-FNAC) alone in the diagnostic assessment of thyroid nodules. Secondary trial outcomes, reported here, assessed the accuracy of ultrasound-alone (US) compared with US-guided FNAC to inform and update current practice guidelines. Adults with single or multiple thyroid nodules who had not undergone previous FNAC were eligible. Radiologists assessed all thyroid nodules using US alone, thereby enabling assessment of its accuracy (sensitivity and specificity) versus US-FNAC. Of the 982 participants, a final definitive diagnosis was obtained in 688, who were included in the final analyses. The sensitivity of US-alone was the same as US-FNAC (0.91, [95% CI 0.85, 0.97] vs 0.87 [95%CI 0.80-0.95], p=0.37). US alone had statistically significant lower specificity than US-FNAC alone (0.48 vs 0.67 respectively, p
doi_str_mv 10.1210/clinem/dgae682
format article
fullrecord <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_3112527837</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3112527837</sourcerecordid><originalsourceid>FETCH-LOGICAL-c220t-8bd0dd750945f90b56dc0517e194a50936f4bfb260eeb5af6d5c2640af0d332a3</originalsourceid><addsrcrecordid>eNpNkL1PwzAQxS0EoqWwMiKPLGnPdpw0bBW0UKlqlyKxRY4_ipETFztB6n9PUAtiOt29d096P4RuCYwJJTCRzja6nqid0NmUnqEhKVKe5KTIz9EQgJKkyOnbAF3F-AFA0pSzSzRgBeMFcBgi_2TFrvGxtRLvdTA-1KKRGnuDO9cGEX3XKPwVx__WZNdZpRVerGcS2wa374fgrcKNV53T8QEr0Qpsgq97SeO5E9vlZo3bYIW7RhdGuKhvTnOEXhfz7eNLsto8Lx9nq0RSCm0yrRQolXPo25gCKp4pCZzkuq8n-ivLTFqZimagdcWFyRSXNEtBGFCMUcFG6P6Yuw_-s9OxLWsbpXZONNp3sWSEUE7zKct76_holcHHGLQp98HWIhxKAuUP5PIIuTxB7h_uTtldVWv1Z_-lyr4BK457ZA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3112527837</pqid></control><display><type>article</type><title>Diagnostic performance of ultrasound vs. ultrasound-guided FNAc in thyroid nodules: data from the ElaTION trial</title><source>Oxford Journals Online</source><creator>Mehanna, Hisham ; Nankivell, Paul ; Boelaert, Kristien ; Woolley, Rebecca ; Sharma, Neil ; Sidhu, Paul S ; Madani, Gitta ; Da Forno, Philip ; Moreman, Catherine ; Palmer, Andrew ; Fulton-Lieuw, Tessa ; Taylor, Judith ; Rajaguru, Kanchana ; Bekker, Jasper ; Vaidhyanath, Ram ; Rehman, Thaj ; Deeks, Jon</creator><creatorcontrib>Mehanna, Hisham ; Nankivell, Paul ; Boelaert, Kristien ; Woolley, Rebecca ; Sharma, Neil ; Sidhu, Paul S ; Madani, Gitta ; Da Forno, Philip ; Moreman, Catherine ; Palmer, Andrew ; Fulton-Lieuw, Tessa ; Taylor, Judith ; Rajaguru, Kanchana ; Bekker, Jasper ; Vaidhyanath, Ram ; Rehman, Thaj ; Deeks, Jon</creatorcontrib><description>ElaTION is a large multi-centre pragmatic randomised controlled trial, performed in 18 secondary/tertiary hospitals across England, comparing elastography ultrasound-guided fine needle aspiration cytology (EUS-FNAC) with ultrasound-guided FNAC (US-FNAC) alone in the diagnostic assessment of thyroid nodules. Secondary trial outcomes, reported here, assessed the accuracy of ultrasound-alone (US) compared with US-guided FNAC to inform and update current practice guidelines. Adults with single or multiple thyroid nodules who had not undergone previous FNAC were eligible. Radiologists assessed all thyroid nodules using US alone, thereby enabling assessment of its accuracy (sensitivity and specificity) versus US-FNAC. Of the 982 participants, a final definitive diagnosis was obtained in 688, who were included in the final analyses. The sensitivity of US-alone was the same as US-FNAC (0.91, [95% CI 0.85, 0.97] vs 0.87 [95%CI 0.80-0.95], p=0.37). US alone had statistically significant lower specificity than US-FNAC alone (0.48 vs 0.67 respectively, p&lt;0.0001). The malignancy rate on histology in a nodule classified as benign on ultrasound (U2) was 9/263 (3.42%) and on cytology (Thy2) was 15/353 (4.25%), whereas the malignancy rate in a nodule that was benign on both (U2, Thy2) was 3/210 (1.43%). Malignancy risk for U3, U4, and U5 nodules was 68/304 (22.4%), 43/83 (51.8%), and 29/38 (76.3%) respectively (p&lt;0.0001). Yet 80/982 (8%) patients were discharged despite having U3-U5 scans with Thy1 (non-diagnostic) FNAC and no definitive diagnosis.Malignancy risk was higher in smaller nodules: &lt;10mm 23/60 (38.3%), 10-20mm 46/162 (28.4 %), and &gt;20mm 80/466 (17.2%) (p&lt;0.0001). Nodules with indeterminate cytology with atypical features (Thy3a) carried a similar malignancy risk to those with indeterminate cytology (Thy3/3f): 27/95 (28.4%) versus 42/113 (37.2%) respectively (p=0.18). Ultrasound alone appears to be an effective diagnostic modality in thyroid nodules, confirming the recommendations of recent guidelines and the BTA classification. However, findings also suggest caution regarding existing recommendations for conservative management of non-diagnostic (Thy1/Bethesda I) and atypical (Thy3a/Bethesda III) nodules. In those cases, ultrasound (U3-5) features may help identify high-risk subgroups for more proactive management.</description><identifier>ISSN: 0021-972X</identifier><identifier>ISSN: 1945-7197</identifier><identifier>EISSN: 1945-7197</identifier><identifier>DOI: 10.1210/clinem/dgae682</identifier><identifier>PMID: 39359050</identifier><language>eng</language><publisher>United States</publisher><ispartof>The journal of clinical endocrinology and metabolism, 2024-10</ispartof><rights>The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c220t-8bd0dd750945f90b56dc0517e194a50936f4bfb260eeb5af6d5c2640af0d332a3</cites><orcidid>0000-0003-4664-6117 ; 0000-0001-5119-1431 ; 0000-0002-5544-6224 ; 0000-0002-6435-177X ; 0000-0003-1928-4077 ; 0000-0001-6776-0977</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39359050$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mehanna, Hisham</creatorcontrib><creatorcontrib>Nankivell, Paul</creatorcontrib><creatorcontrib>Boelaert, Kristien</creatorcontrib><creatorcontrib>Woolley, Rebecca</creatorcontrib><creatorcontrib>Sharma, Neil</creatorcontrib><creatorcontrib>Sidhu, Paul S</creatorcontrib><creatorcontrib>Madani, Gitta</creatorcontrib><creatorcontrib>Da Forno, Philip</creatorcontrib><creatorcontrib>Moreman, Catherine</creatorcontrib><creatorcontrib>Palmer, Andrew</creatorcontrib><creatorcontrib>Fulton-Lieuw, Tessa</creatorcontrib><creatorcontrib>Taylor, Judith</creatorcontrib><creatorcontrib>Rajaguru, Kanchana</creatorcontrib><creatorcontrib>Bekker, Jasper</creatorcontrib><creatorcontrib>Vaidhyanath, Ram</creatorcontrib><creatorcontrib>Rehman, Thaj</creatorcontrib><creatorcontrib>Deeks, Jon</creatorcontrib><title>Diagnostic performance of ultrasound vs. ultrasound-guided FNAc in thyroid nodules: data from the ElaTION trial</title><title>The journal of clinical endocrinology and metabolism</title><addtitle>J Clin Endocrinol Metab</addtitle><description>ElaTION is a large multi-centre pragmatic randomised controlled trial, performed in 18 secondary/tertiary hospitals across England, comparing elastography ultrasound-guided fine needle aspiration cytology (EUS-FNAC) with ultrasound-guided FNAC (US-FNAC) alone in the diagnostic assessment of thyroid nodules. Secondary trial outcomes, reported here, assessed the accuracy of ultrasound-alone (US) compared with US-guided FNAC to inform and update current practice guidelines. Adults with single or multiple thyroid nodules who had not undergone previous FNAC were eligible. Radiologists assessed all thyroid nodules using US alone, thereby enabling assessment of its accuracy (sensitivity and specificity) versus US-FNAC. Of the 982 participants, a final definitive diagnosis was obtained in 688, who were included in the final analyses. The sensitivity of US-alone was the same as US-FNAC (0.91, [95% CI 0.85, 0.97] vs 0.87 [95%CI 0.80-0.95], p=0.37). US alone had statistically significant lower specificity than US-FNAC alone (0.48 vs 0.67 respectively, p&lt;0.0001). The malignancy rate on histology in a nodule classified as benign on ultrasound (U2) was 9/263 (3.42%) and on cytology (Thy2) was 15/353 (4.25%), whereas the malignancy rate in a nodule that was benign on both (U2, Thy2) was 3/210 (1.43%). Malignancy risk for U3, U4, and U5 nodules was 68/304 (22.4%), 43/83 (51.8%), and 29/38 (76.3%) respectively (p&lt;0.0001). Yet 80/982 (8%) patients were discharged despite having U3-U5 scans with Thy1 (non-diagnostic) FNAC and no definitive diagnosis.Malignancy risk was higher in smaller nodules: &lt;10mm 23/60 (38.3%), 10-20mm 46/162 (28.4 %), and &gt;20mm 80/466 (17.2%) (p&lt;0.0001). Nodules with indeterminate cytology with atypical features (Thy3a) carried a similar malignancy risk to those with indeterminate cytology (Thy3/3f): 27/95 (28.4%) versus 42/113 (37.2%) respectively (p=0.18). Ultrasound alone appears to be an effective diagnostic modality in thyroid nodules, confirming the recommendations of recent guidelines and the BTA classification. However, findings also suggest caution regarding existing recommendations for conservative management of non-diagnostic (Thy1/Bethesda I) and atypical (Thy3a/Bethesda III) nodules. In those cases, ultrasound (U3-5) features may help identify high-risk subgroups for more proactive management.</description><issn>0021-972X</issn><issn>1945-7197</issn><issn>1945-7197</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNpNkL1PwzAQxS0EoqWwMiKPLGnPdpw0bBW0UKlqlyKxRY4_ipETFztB6n9PUAtiOt29d096P4RuCYwJJTCRzja6nqid0NmUnqEhKVKe5KTIz9EQgJKkyOnbAF3F-AFA0pSzSzRgBeMFcBgi_2TFrvGxtRLvdTA-1KKRGnuDO9cGEX3XKPwVx__WZNdZpRVerGcS2wa374fgrcKNV53T8QEr0Qpsgq97SeO5E9vlZo3bYIW7RhdGuKhvTnOEXhfz7eNLsto8Lx9nq0RSCm0yrRQolXPo25gCKp4pCZzkuq8n-ivLTFqZimagdcWFyRSXNEtBGFCMUcFG6P6Yuw_-s9OxLWsbpXZONNp3sWSEUE7zKct76_holcHHGLQp98HWIhxKAuUP5PIIuTxB7h_uTtldVWv1Z_-lyr4BK457ZA</recordid><startdate>20241003</startdate><enddate>20241003</enddate><creator>Mehanna, Hisham</creator><creator>Nankivell, Paul</creator><creator>Boelaert, Kristien</creator><creator>Woolley, Rebecca</creator><creator>Sharma, Neil</creator><creator>Sidhu, Paul S</creator><creator>Madani, Gitta</creator><creator>Da Forno, Philip</creator><creator>Moreman, Catherine</creator><creator>Palmer, Andrew</creator><creator>Fulton-Lieuw, Tessa</creator><creator>Taylor, Judith</creator><creator>Rajaguru, Kanchana</creator><creator>Bekker, Jasper</creator><creator>Vaidhyanath, Ram</creator><creator>Rehman, Thaj</creator><creator>Deeks, Jon</creator><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0003-4664-6117</orcidid><orcidid>https://orcid.org/0000-0001-5119-1431</orcidid><orcidid>https://orcid.org/0000-0002-5544-6224</orcidid><orcidid>https://orcid.org/0000-0002-6435-177X</orcidid><orcidid>https://orcid.org/0000-0003-1928-4077</orcidid><orcidid>https://orcid.org/0000-0001-6776-0977</orcidid></search><sort><creationdate>20241003</creationdate><title>Diagnostic performance of ultrasound vs. ultrasound-guided FNAc in thyroid nodules: data from the ElaTION trial</title><author>Mehanna, Hisham ; Nankivell, Paul ; Boelaert, Kristien ; Woolley, Rebecca ; Sharma, Neil ; Sidhu, Paul S ; Madani, Gitta ; Da Forno, Philip ; Moreman, Catherine ; Palmer, Andrew ; Fulton-Lieuw, Tessa ; Taylor, Judith ; Rajaguru, Kanchana ; Bekker, Jasper ; Vaidhyanath, Ram ; Rehman, Thaj ; Deeks, Jon</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c220t-8bd0dd750945f90b56dc0517e194a50936f4bfb260eeb5af6d5c2640af0d332a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mehanna, Hisham</creatorcontrib><creatorcontrib>Nankivell, Paul</creatorcontrib><creatorcontrib>Boelaert, Kristien</creatorcontrib><creatorcontrib>Woolley, Rebecca</creatorcontrib><creatorcontrib>Sharma, Neil</creatorcontrib><creatorcontrib>Sidhu, Paul S</creatorcontrib><creatorcontrib>Madani, Gitta</creatorcontrib><creatorcontrib>Da Forno, Philip</creatorcontrib><creatorcontrib>Moreman, Catherine</creatorcontrib><creatorcontrib>Palmer, Andrew</creatorcontrib><creatorcontrib>Fulton-Lieuw, Tessa</creatorcontrib><creatorcontrib>Taylor, Judith</creatorcontrib><creatorcontrib>Rajaguru, Kanchana</creatorcontrib><creatorcontrib>Bekker, Jasper</creatorcontrib><creatorcontrib>Vaidhyanath, Ram</creatorcontrib><creatorcontrib>Rehman, Thaj</creatorcontrib><creatorcontrib>Deeks, Jon</creatorcontrib><collection>PubMed</collection><collection>CrossRef</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>Mehanna, Hisham</au><au>Nankivell, Paul</au><au>Boelaert, Kristien</au><au>Woolley, Rebecca</au><au>Sharma, Neil</au><au>Sidhu, Paul S</au><au>Madani, Gitta</au><au>Da Forno, Philip</au><au>Moreman, Catherine</au><au>Palmer, Andrew</au><au>Fulton-Lieuw, Tessa</au><au>Taylor, Judith</au><au>Rajaguru, Kanchana</au><au>Bekker, Jasper</au><au>Vaidhyanath, Ram</au><au>Rehman, Thaj</au><au>Deeks, Jon</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Diagnostic performance of ultrasound vs. ultrasound-guided FNAc in thyroid nodules: data from the ElaTION trial</atitle><jtitle>The journal of clinical endocrinology and metabolism</jtitle><addtitle>J Clin Endocrinol Metab</addtitle><date>2024-10-03</date><risdate>2024</risdate><issn>0021-972X</issn><issn>1945-7197</issn><eissn>1945-7197</eissn><abstract>ElaTION is a large multi-centre pragmatic randomised controlled trial, performed in 18 secondary/tertiary hospitals across England, comparing elastography ultrasound-guided fine needle aspiration cytology (EUS-FNAC) with ultrasound-guided FNAC (US-FNAC) alone in the diagnostic assessment of thyroid nodules. Secondary trial outcomes, reported here, assessed the accuracy of ultrasound-alone (US) compared with US-guided FNAC to inform and update current practice guidelines. Adults with single or multiple thyroid nodules who had not undergone previous FNAC were eligible. Radiologists assessed all thyroid nodules using US alone, thereby enabling assessment of its accuracy (sensitivity and specificity) versus US-FNAC. Of the 982 participants, a final definitive diagnosis was obtained in 688, who were included in the final analyses. The sensitivity of US-alone was the same as US-FNAC (0.91, [95% CI 0.85, 0.97] vs 0.87 [95%CI 0.80-0.95], p=0.37). US alone had statistically significant lower specificity than US-FNAC alone (0.48 vs 0.67 respectively, p&lt;0.0001). The malignancy rate on histology in a nodule classified as benign on ultrasound (U2) was 9/263 (3.42%) and on cytology (Thy2) was 15/353 (4.25%), whereas the malignancy rate in a nodule that was benign on both (U2, Thy2) was 3/210 (1.43%). Malignancy risk for U3, U4, and U5 nodules was 68/304 (22.4%), 43/83 (51.8%), and 29/38 (76.3%) respectively (p&lt;0.0001). Yet 80/982 (8%) patients were discharged despite having U3-U5 scans with Thy1 (non-diagnostic) FNAC and no definitive diagnosis.Malignancy risk was higher in smaller nodules: &lt;10mm 23/60 (38.3%), 10-20mm 46/162 (28.4 %), and &gt;20mm 80/466 (17.2%) (p&lt;0.0001). Nodules with indeterminate cytology with atypical features (Thy3a) carried a similar malignancy risk to those with indeterminate cytology (Thy3/3f): 27/95 (28.4%) versus 42/113 (37.2%) respectively (p=0.18). Ultrasound alone appears to be an effective diagnostic modality in thyroid nodules, confirming the recommendations of recent guidelines and the BTA classification. However, findings also suggest caution regarding existing recommendations for conservative management of non-diagnostic (Thy1/Bethesda I) and atypical (Thy3a/Bethesda III) nodules. In those cases, ultrasound (U3-5) features may help identify high-risk subgroups for more proactive management.</abstract><cop>United States</cop><pmid>39359050</pmid><doi>10.1210/clinem/dgae682</doi><orcidid>https://orcid.org/0000-0003-4664-6117</orcidid><orcidid>https://orcid.org/0000-0001-5119-1431</orcidid><orcidid>https://orcid.org/0000-0002-5544-6224</orcidid><orcidid>https://orcid.org/0000-0002-6435-177X</orcidid><orcidid>https://orcid.org/0000-0003-1928-4077</orcidid><orcidid>https://orcid.org/0000-0001-6776-0977</orcidid><oa>free_for_read</oa></addata></record>
fulltext fulltext
identifier ISSN: 0021-972X
ispartof The journal of clinical endocrinology and metabolism, 2024-10
issn 0021-972X
1945-7197
1945-7197
language eng
recordid cdi_proquest_miscellaneous_3112527837
source Oxford Journals Online
title Diagnostic performance of ultrasound vs. ultrasound-guided FNAc in thyroid nodules: data from the ElaTION trial
url http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-27T02%3A29%3A29IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Diagnostic%20performance%20of%20ultrasound%20vs.%20ultrasound-guided%20FNAc%20in%20thyroid%20nodules:%20data%20from%20the%20ElaTION%20trial&rft.jtitle=The%20journal%20of%20clinical%20endocrinology%20and%20metabolism&rft.au=Mehanna,%20Hisham&rft.date=2024-10-03&rft.issn=0021-972X&rft.eissn=1945-7197&rft_id=info:doi/10.1210/clinem/dgae682&rft_dat=%3Cproquest_cross%3E3112527837%3C/proquest_cross%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c220t-8bd0dd750945f90b56dc0517e194a50936f4bfb260eeb5af6d5c2640af0d332a3%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=3112527837&rft_id=info:pmid/39359050&rfr_iscdi=true