Endoscopic radiofrequency ablation or surveillance in patients with Barrett’s oesophagus with confirmed low-grade dysplasia: a multicentre randomised trial

ObjectiveDue to an annual progression rate of Barrett’s oesophagus (BO) with low-grade dysplasia (LGD) between 9% and 13% per year endoscopic ablation therapy is preferred to surveillance. Since this recommendation is based on only one randomised trial, we aimed at checking these results by another...

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Veröffentlicht in:Gut 2021-06, Vol.70 (6), p.1014-1022
Hauptverfasser: Barret, Maximilien, Pioche, Mathieu, Terris, Benoit, Ponchon, Thierry, Cholet, Franck, Zerbib, Frank, Chabrun, Edouard, Le Rhun, Marc, Coron, Emmanuel, Giovannini, Marc, Caillol, Fabrice, Laugier, René, Jacques, Jeremie, Legros, Romain, Boustiere, Christian, Rahmi, Gabriel, Metivier-Cesbron, Elodie, Vanbiervliet, Geoffroy, Bauret, Paul, Escourrou, Jean, Branche, Julien, Jilet, Lea, Abdoul, Hendy, Kaddour, Nadira, Leblanc, Sarah, Bensoussan, Michael, Prat, Frederic, Chaussade, Stanislas
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container_issue 6
container_start_page 1014
container_title Gut
container_volume 70
creator Barret, Maximilien
Pioche, Mathieu
Terris, Benoit
Ponchon, Thierry
Cholet, Franck
Zerbib, Frank
Chabrun, Edouard
Le Rhun, Marc
Coron, Emmanuel
Giovannini, Marc
Caillol, Fabrice
Laugier, René
Jacques, Jeremie
Legros, Romain
Boustiere, Christian
Rahmi, Gabriel
Metivier-Cesbron, Elodie
Vanbiervliet, Geoffroy
Bauret, Paul
Escourrou, Jean
Branche, Julien
Jilet, Lea
Abdoul, Hendy
Kaddour, Nadira
Leblanc, Sarah
Bensoussan, Michael
Prat, Frederic
Chaussade, Stanislas
description ObjectiveDue to an annual progression rate of Barrett’s oesophagus (BO) with low-grade dysplasia (LGD) between 9% and 13% per year endoscopic ablation therapy is preferred to surveillance. Since this recommendation is based on only one randomised trial, we aimed at checking these results by another multicentre randomised trial with a similar design.DesignA prospective randomised study was performed in 14 centres comparing radiofrequency ablation (RFA) (maximum of 4 sessions) to annual endoscopic surveillance, including patients with a confirmed diagnosis of BO with LGD. Primary outcome was the prevalence of LGD at 3 years. Secondary outcomes were the prevalence of LGD at 1 year, the complete eradication of intestinal metaplasia (CE-IM) at 3 years, the rate of neoplastic progression at 3 years and the treatment-related morbidity.Results125 patients were initially included, of whom 82 with confirmed LGD (76 men, mean age 62.3 years) were finally randomised, 40 patients in the RFA and 42 in the surveillance group. At 3 years, CE-IM rates were 35% vs 0% in the RFA and surveillance groups, respectively (p
doi_str_mv 10.1136/gutjnl-2020-322082
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Since this recommendation is based on only one randomised trial, we aimed at checking these results by another multicentre randomised trial with a similar design.DesignA prospective randomised study was performed in 14 centres comparing radiofrequency ablation (RFA) (maximum of 4 sessions) to annual endoscopic surveillance, including patients with a confirmed diagnosis of BO with LGD. Primary outcome was the prevalence of LGD at 3 years. Secondary outcomes were the prevalence of LGD at 1 year, the complete eradication of intestinal metaplasia (CE-IM) at 3 years, the rate of neoplastic progression at 3 years and the treatment-related morbidity.Results125 patients were initially included, of whom 82 with confirmed LGD (76 men, mean age 62.3 years) were finally randomised, 40 patients in the RFA and 42 in the surveillance group. At 3 years, CE-IM rates were 35% vs 0% in the RFA and surveillance groups, respectively (p&lt;0.001). At the same time, the prevalence LGD was 34.3% (95% CI 18.6 to 50.0) in the RFA group vs 58.1% (95% CI 40.7 to 75.4) in the surveillance group (OR=0.38 (95% CI 0.14 to 1.02), p=0.05). Neoplastic progression was found in 12.5% (RFA) vs 26.2% (surveillance; p=0.15). The complication rate was maximal after the first RFA treatment (16.9%).ConclusionRFA modestly reduced the prevalence of LGD as well as progression risk at 3 years. The risk-benefit balance of endoscopic ablation therapy should therefore be carefully weighted against surveillance in patients with BO with confirmed LGD.Trial registration number NCT01360541.</description><identifier>ISSN: 0017-5749</identifier><identifier>EISSN: 1468-3288</identifier><identifier>DOI: 10.1136/gutjnl-2020-322082</identifier><identifier>PMID: 33685969</identifier><language>eng</language><publisher>England: BMJ Publishing Group Ltd and British Society of Gastroenterology</publisher><subject>Ablation ; Adenocarcinoma - diagnostic imaging ; Adenocarcinoma - pathology ; Aged ; Anesthesia ; Barrett Esophagus - diagnostic imaging ; Barrett Esophagus - pathology ; Barrett Esophagus - therapy ; Barrett's oesophagus ; Biopsy ; Catheters ; Disease Progression ; Dysplasia ; endoscopic procedures ; Endoscopy ; Endoscopy, Gastrointestinal ; Eradication ; Esophageal cancer ; Esophageal Neoplasms - diagnostic imaging ; Esophageal Neoplasms - pathology ; Esophagus ; Female ; Hospitals, High-Volume ; Hospitals, Low-Volume ; Human health and pathology ; Humans ; Hépatology and Gastroenterology ; Intestine ; Life Sciences ; Male ; Metaplasia ; Middle Aged ; Morbidity ; oesophageal cancer ; Oesophagus ; Pathology ; Patients ; Prospective Studies ; Radiofrequency ablation ; Radiofrequency Ablation - adverse effects ; Surveillance ; Time Factors ; Treatment Outcome ; Watchful Waiting</subject><ispartof>Gut, 2021-06, Vol.70 (6), p.1014-1022</ispartof><rights>Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>2021 Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b442t-303700d17d1b3671cb98f30b64776f10a9282a866421d8575fef2ac2112747a43</citedby><cites>FETCH-LOGICAL-b442t-303700d17d1b3671cb98f30b64776f10a9282a866421d8575fef2ac2112747a43</cites><orcidid>0000-0002-0566-7870 ; 0000-0002-6482-2375 ; 0000-0002-9452-1450 ; 0000-0002-6802-2121 ; 0000-0003-2251-9076</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33685969$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.science/hal-04470392$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Barret, Maximilien</creatorcontrib><creatorcontrib>Pioche, Mathieu</creatorcontrib><creatorcontrib>Terris, Benoit</creatorcontrib><creatorcontrib>Ponchon, Thierry</creatorcontrib><creatorcontrib>Cholet, Franck</creatorcontrib><creatorcontrib>Zerbib, Frank</creatorcontrib><creatorcontrib>Chabrun, Edouard</creatorcontrib><creatorcontrib>Le Rhun, Marc</creatorcontrib><creatorcontrib>Coron, Emmanuel</creatorcontrib><creatorcontrib>Giovannini, Marc</creatorcontrib><creatorcontrib>Caillol, Fabrice</creatorcontrib><creatorcontrib>Laugier, René</creatorcontrib><creatorcontrib>Jacques, Jeremie</creatorcontrib><creatorcontrib>Legros, Romain</creatorcontrib><creatorcontrib>Boustiere, Christian</creatorcontrib><creatorcontrib>Rahmi, Gabriel</creatorcontrib><creatorcontrib>Metivier-Cesbron, Elodie</creatorcontrib><creatorcontrib>Vanbiervliet, Geoffroy</creatorcontrib><creatorcontrib>Bauret, Paul</creatorcontrib><creatorcontrib>Escourrou, Jean</creatorcontrib><creatorcontrib>Branche, Julien</creatorcontrib><creatorcontrib>Jilet, Lea</creatorcontrib><creatorcontrib>Abdoul, Hendy</creatorcontrib><creatorcontrib>Kaddour, Nadira</creatorcontrib><creatorcontrib>Leblanc, Sarah</creatorcontrib><creatorcontrib>Bensoussan, Michael</creatorcontrib><creatorcontrib>Prat, Frederic</creatorcontrib><creatorcontrib>Chaussade, Stanislas</creatorcontrib><title>Endoscopic radiofrequency ablation or surveillance in patients with Barrett’s oesophagus with confirmed low-grade dysplasia: a multicentre randomised trial</title><title>Gut</title><addtitle>Gut</addtitle><addtitle>Gut</addtitle><description>ObjectiveDue to an annual progression rate of Barrett’s oesophagus (BO) with low-grade dysplasia (LGD) between 9% and 13% per year endoscopic ablation therapy is preferred to surveillance. Since this recommendation is based on only one randomised trial, we aimed at checking these results by another multicentre randomised trial with a similar design.DesignA prospective randomised study was performed in 14 centres comparing radiofrequency ablation (RFA) (maximum of 4 sessions) to annual endoscopic surveillance, including patients with a confirmed diagnosis of BO with LGD. Primary outcome was the prevalence of LGD at 3 years. Secondary outcomes were the prevalence of LGD at 1 year, the complete eradication of intestinal metaplasia (CE-IM) at 3 years, the rate of neoplastic progression at 3 years and the treatment-related morbidity.Results125 patients were initially included, of whom 82 with confirmed LGD (76 men, mean age 62.3 years) were finally randomised, 40 patients in the RFA and 42 in the surveillance group. At 3 years, CE-IM rates were 35% vs 0% in the RFA and surveillance groups, respectively (p&lt;0.001). At the same time, the prevalence LGD was 34.3% (95% CI 18.6 to 50.0) in the RFA group vs 58.1% (95% CI 40.7 to 75.4) in the surveillance group (OR=0.38 (95% CI 0.14 to 1.02), p=0.05). Neoplastic progression was found in 12.5% (RFA) vs 26.2% (surveillance; p=0.15). The complication rate was maximal after the first RFA treatment (16.9%).ConclusionRFA modestly reduced the prevalence of LGD as well as progression risk at 3 years. The risk-benefit balance of endoscopic ablation therapy should therefore be carefully weighted against surveillance in patients with BO with confirmed LGD.Trial registration number NCT01360541.</description><subject>Ablation</subject><subject>Adenocarcinoma - diagnostic imaging</subject><subject>Adenocarcinoma - pathology</subject><subject>Aged</subject><subject>Anesthesia</subject><subject>Barrett Esophagus - diagnostic imaging</subject><subject>Barrett Esophagus - pathology</subject><subject>Barrett Esophagus - therapy</subject><subject>Barrett's oesophagus</subject><subject>Biopsy</subject><subject>Catheters</subject><subject>Disease Progression</subject><subject>Dysplasia</subject><subject>endoscopic procedures</subject><subject>Endoscopy</subject><subject>Endoscopy, Gastrointestinal</subject><subject>Eradication</subject><subject>Esophageal cancer</subject><subject>Esophageal Neoplasms - diagnostic imaging</subject><subject>Esophageal Neoplasms - pathology</subject><subject>Esophagus</subject><subject>Female</subject><subject>Hospitals, High-Volume</subject><subject>Hospitals, Low-Volume</subject><subject>Human health and pathology</subject><subject>Humans</subject><subject>Hépatology and Gastroenterology</subject><subject>Intestine</subject><subject>Life Sciences</subject><subject>Male</subject><subject>Metaplasia</subject><subject>Middle Aged</subject><subject>Morbidity</subject><subject>oesophageal cancer</subject><subject>Oesophagus</subject><subject>Pathology</subject><subject>Patients</subject><subject>Prospective Studies</subject><subject>Radiofrequency ablation</subject><subject>Radiofrequency Ablation - adverse effects</subject><subject>Surveillance</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Watchful Waiting</subject><issn>0017-5749</issn><issn>1468-3288</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqNkc1u1DAUhSMEokPhBVggS2xgkeK_-IddqQpFGokNrC3HcWY8cuJgO61mx2uw6Mv1SfAowyCxQKws-3733ON7quolghcIEfZuM-fd6GsMMawJxlDgR9UKUSbKTYjH1QpCxOuGU3lWPUtpByEUQqKn1RkhTDSSyVV1fz12IZkwOQOi7lzoo_0-29HsgW69zi6MIESQ5nhrnfd6NBa4EUylYsecwJ3LW_BBx2hzfvjxM4FgU5i2ejMfayaMvYuD7YAPd_WmzLCg26fJ6-T0e6DBMPvsTBGLtjgobgaXCp2j0_559aTXPtkXx_O8-vbx-uvVTb3-8unz1eW6binFuSaQcAg7xDvUEsaRaaXoCWwZ5Zz1CGqJBdaCMYpRJxre9LbH2mCEMKdcU3JevV10t9qrKbpBx70K2qmby7U6vEFKOSQS36LCvlnYKYayqZRVMWzsYTc2zElhKiWRhCBW0Nd_obswx7H8ROEGF9eMUFkovFAmhpSi7U8OEFSHoNUStDoErZagS9Oro_TcluWeWn4nW4B6Adph93-CF3_4k81_NPwCmUDE3A</recordid><startdate>20210601</startdate><enddate>20210601</enddate><creator>Barret, Maximilien</creator><creator>Pioche, Mathieu</creator><creator>Terris, Benoit</creator><creator>Ponchon, Thierry</creator><creator>Cholet, Franck</creator><creator>Zerbib, Frank</creator><creator>Chabrun, Edouard</creator><creator>Le Rhun, Marc</creator><creator>Coron, Emmanuel</creator><creator>Giovannini, Marc</creator><creator>Caillol, Fabrice</creator><creator>Laugier, René</creator><creator>Jacques, Jeremie</creator><creator>Legros, Romain</creator><creator>Boustiere, Christian</creator><creator>Rahmi, Gabriel</creator><creator>Metivier-Cesbron, Elodie</creator><creator>Vanbiervliet, Geoffroy</creator><creator>Bauret, Paul</creator><creator>Escourrou, Jean</creator><creator>Branche, Julien</creator><creator>Jilet, Lea</creator><creator>Abdoul, Hendy</creator><creator>Kaddour, Nadira</creator><creator>Leblanc, Sarah</creator><creator>Bensoussan, Michael</creator><creator>Prat, Frederic</creator><creator>Chaussade, Stanislas</creator><general>BMJ Publishing Group Ltd and British Society of Gastroenterology</general><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>M7P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><scope>1XC</scope><orcidid>https://orcid.org/0000-0002-0566-7870</orcidid><orcidid>https://orcid.org/0000-0002-6482-2375</orcidid><orcidid>https://orcid.org/0000-0002-9452-1450</orcidid><orcidid>https://orcid.org/0000-0002-6802-2121</orcidid><orcidid>https://orcid.org/0000-0003-2251-9076</orcidid></search><sort><creationdate>20210601</creationdate><title>Endoscopic radiofrequency ablation or surveillance in patients with Barrett’s oesophagus with confirmed low-grade dysplasia: a multicentre randomised trial</title><author>Barret, Maximilien ; Pioche, Mathieu ; Terris, Benoit ; Ponchon, Thierry ; Cholet, Franck ; Zerbib, Frank ; Chabrun, Edouard ; Le Rhun, Marc ; Coron, Emmanuel ; Giovannini, Marc ; Caillol, Fabrice ; Laugier, René ; Jacques, Jeremie ; Legros, Romain ; Boustiere, Christian ; Rahmi, Gabriel ; Metivier-Cesbron, Elodie ; Vanbiervliet, Geoffroy ; Bauret, Paul ; Escourrou, Jean ; Branche, Julien ; Jilet, Lea ; Abdoul, Hendy ; Kaddour, Nadira ; Leblanc, Sarah ; Bensoussan, Michael ; Prat, Frederic ; Chaussade, Stanislas</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b442t-303700d17d1b3671cb98f30b64776f10a9282a866421d8575fef2ac2112747a43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Ablation</topic><topic>Adenocarcinoma - diagnostic imaging</topic><topic>Adenocarcinoma - pathology</topic><topic>Aged</topic><topic>Anesthesia</topic><topic>Barrett Esophagus - diagnostic imaging</topic><topic>Barrett Esophagus - pathology</topic><topic>Barrett Esophagus - therapy</topic><topic>Barrett's oesophagus</topic><topic>Biopsy</topic><topic>Catheters</topic><topic>Disease Progression</topic><topic>Dysplasia</topic><topic>endoscopic procedures</topic><topic>Endoscopy</topic><topic>Endoscopy, Gastrointestinal</topic><topic>Eradication</topic><topic>Esophageal cancer</topic><topic>Esophageal Neoplasms - diagnostic imaging</topic><topic>Esophageal Neoplasms - pathology</topic><topic>Esophagus</topic><topic>Female</topic><topic>Hospitals, High-Volume</topic><topic>Hospitals, Low-Volume</topic><topic>Human health and pathology</topic><topic>Humans</topic><topic>Hépatology and Gastroenterology</topic><topic>Intestine</topic><topic>Life Sciences</topic><topic>Male</topic><topic>Metaplasia</topic><topic>Middle Aged</topic><topic>Morbidity</topic><topic>oesophageal cancer</topic><topic>Oesophagus</topic><topic>Pathology</topic><topic>Patients</topic><topic>Prospective Studies</topic><topic>Radiofrequency ablation</topic><topic>Radiofrequency Ablation - adverse effects</topic><topic>Surveillance</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Watchful Waiting</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Barret, Maximilien</creatorcontrib><creatorcontrib>Pioche, Mathieu</creatorcontrib><creatorcontrib>Terris, Benoit</creatorcontrib><creatorcontrib>Ponchon, Thierry</creatorcontrib><creatorcontrib>Cholet, Franck</creatorcontrib><creatorcontrib>Zerbib, Frank</creatorcontrib><creatorcontrib>Chabrun, Edouard</creatorcontrib><creatorcontrib>Le Rhun, Marc</creatorcontrib><creatorcontrib>Coron, Emmanuel</creatorcontrib><creatorcontrib>Giovannini, Marc</creatorcontrib><creatorcontrib>Caillol, Fabrice</creatorcontrib><creatorcontrib>Laugier, René</creatorcontrib><creatorcontrib>Jacques, Jeremie</creatorcontrib><creatorcontrib>Legros, Romain</creatorcontrib><creatorcontrib>Boustiere, Christian</creatorcontrib><creatorcontrib>Rahmi, Gabriel</creatorcontrib><creatorcontrib>Metivier-Cesbron, Elodie</creatorcontrib><creatorcontrib>Vanbiervliet, Geoffroy</creatorcontrib><creatorcontrib>Bauret, Paul</creatorcontrib><creatorcontrib>Escourrou, Jean</creatorcontrib><creatorcontrib>Branche, Julien</creatorcontrib><creatorcontrib>Jilet, Lea</creatorcontrib><creatorcontrib>Abdoul, Hendy</creatorcontrib><creatorcontrib>Kaddour, Nadira</creatorcontrib><creatorcontrib>Leblanc, Sarah</creatorcontrib><creatorcontrib>Bensoussan, Michael</creatorcontrib><creatorcontrib>Prat, Frederic</creatorcontrib><creatorcontrib>Chaussade, Stanislas</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health &amp; Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</collection><collection>Biological Science Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>Gut</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Barret, Maximilien</au><au>Pioche, Mathieu</au><au>Terris, Benoit</au><au>Ponchon, Thierry</au><au>Cholet, Franck</au><au>Zerbib, Frank</au><au>Chabrun, Edouard</au><au>Le Rhun, Marc</au><au>Coron, Emmanuel</au><au>Giovannini, Marc</au><au>Caillol, Fabrice</au><au>Laugier, René</au><au>Jacques, Jeremie</au><au>Legros, Romain</au><au>Boustiere, Christian</au><au>Rahmi, Gabriel</au><au>Metivier-Cesbron, Elodie</au><au>Vanbiervliet, Geoffroy</au><au>Bauret, Paul</au><au>Escourrou, Jean</au><au>Branche, Julien</au><au>Jilet, Lea</au><au>Abdoul, Hendy</au><au>Kaddour, Nadira</au><au>Leblanc, Sarah</au><au>Bensoussan, Michael</au><au>Prat, Frederic</au><au>Chaussade, Stanislas</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Endoscopic radiofrequency ablation or surveillance in patients with Barrett’s oesophagus with confirmed low-grade dysplasia: a multicentre randomised trial</atitle><jtitle>Gut</jtitle><stitle>Gut</stitle><addtitle>Gut</addtitle><date>2021-06-01</date><risdate>2021</risdate><volume>70</volume><issue>6</issue><spage>1014</spage><epage>1022</epage><pages>1014-1022</pages><issn>0017-5749</issn><eissn>1468-3288</eissn><abstract>ObjectiveDue to an annual progression rate of Barrett’s oesophagus (BO) with low-grade dysplasia (LGD) between 9% and 13% per year endoscopic ablation therapy is preferred to surveillance. Since this recommendation is based on only one randomised trial, we aimed at checking these results by another multicentre randomised trial with a similar design.DesignA prospective randomised study was performed in 14 centres comparing radiofrequency ablation (RFA) (maximum of 4 sessions) to annual endoscopic surveillance, including patients with a confirmed diagnosis of BO with LGD. Primary outcome was the prevalence of LGD at 3 years. Secondary outcomes were the prevalence of LGD at 1 year, the complete eradication of intestinal metaplasia (CE-IM) at 3 years, the rate of neoplastic progression at 3 years and the treatment-related morbidity.Results125 patients were initially included, of whom 82 with confirmed LGD (76 men, mean age 62.3 years) were finally randomised, 40 patients in the RFA and 42 in the surveillance group. At 3 years, CE-IM rates were 35% vs 0% in the RFA and surveillance groups, respectively (p&lt;0.001). At the same time, the prevalence LGD was 34.3% (95% CI 18.6 to 50.0) in the RFA group vs 58.1% (95% CI 40.7 to 75.4) in the surveillance group (OR=0.38 (95% CI 0.14 to 1.02), p=0.05). Neoplastic progression was found in 12.5% (RFA) vs 26.2% (surveillance; p=0.15). The complication rate was maximal after the first RFA treatment (16.9%).ConclusionRFA modestly reduced the prevalence of LGD as well as progression risk at 3 years. The risk-benefit balance of endoscopic ablation therapy should therefore be carefully weighted against surveillance in patients with BO with confirmed LGD.Trial registration number NCT01360541.</abstract><cop>England</cop><pub>BMJ Publishing Group Ltd and British Society of Gastroenterology</pub><pmid>33685969</pmid><doi>10.1136/gutjnl-2020-322082</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-0566-7870</orcidid><orcidid>https://orcid.org/0000-0002-6482-2375</orcidid><orcidid>https://orcid.org/0000-0002-9452-1450</orcidid><orcidid>https://orcid.org/0000-0002-6802-2121</orcidid><orcidid>https://orcid.org/0000-0003-2251-9076</orcidid></addata></record>
fulltext fulltext
identifier ISSN: 0017-5749
ispartof Gut, 2021-06, Vol.70 (6), p.1014-1022
issn 0017-5749
1468-3288
language eng
recordid cdi_hal_primary_oai_HAL_hal_04470392v1
source MEDLINE; PubMed Central
subjects Ablation
Adenocarcinoma - diagnostic imaging
Adenocarcinoma - pathology
Aged
Anesthesia
Barrett Esophagus - diagnostic imaging
Barrett Esophagus - pathology
Barrett Esophagus - therapy
Barrett's oesophagus
Biopsy
Catheters
Disease Progression
Dysplasia
endoscopic procedures
Endoscopy
Endoscopy, Gastrointestinal
Eradication
Esophageal cancer
Esophageal Neoplasms - diagnostic imaging
Esophageal Neoplasms - pathology
Esophagus
Female
Hospitals, High-Volume
Hospitals, Low-Volume
Human health and pathology
Humans
Hépatology and Gastroenterology
Intestine
Life Sciences
Male
Metaplasia
Middle Aged
Morbidity
oesophageal cancer
Oesophagus
Pathology
Patients
Prospective Studies
Radiofrequency ablation
Radiofrequency Ablation - adverse effects
Surveillance
Time Factors
Treatment Outcome
Watchful Waiting
title Endoscopic radiofrequency ablation or surveillance in patients with Barrett’s oesophagus with confirmed low-grade dysplasia: a multicentre randomised trial
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