Randomized controlled trial investigating use of submucosal injection of EverLift™ in rates of complete resection of non-pedunculated 4–9 mm polyps
Introduction Currently, cold snare polypectomy (CSP) without submucosal injection is recommended for removing polyps
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| Veröffentlicht in: | International journal of colorectal disease 2022-06, Vol.37 (6), p.1273-1279 |
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| container_title | International journal of colorectal disease |
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| creator | Wei, Mike T. Louie, Christine Y. Chen, Yu Pan, Jennifer Y. Quan, Susan Y. Wong, Robert Brown, Ryanne Clark, Melissa Jensen, Kristin Lau, Hubert Friedland, Shai |
| description | Introduction
Currently, cold snare polypectomy (CSP) without submucosal injection is recommended for removing polyps |
| doi_str_mv | 10.1007/s00384-022-04136-4 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_proqu</sourceid><recordid>TN_cdi_proquest_journals_2673177715</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A706112518</galeid><sourcerecordid>A706112518</sourcerecordid><originalsourceid>FETCH-LOGICAL-c409t-99bc419c5ec97f2b80f3345b6bd5c8f8152fc0677bf573c09c8a97a70006cdb33</originalsourceid><addsrcrecordid>eNp9kc1qFTEUx4NYbK2-gAsJuJ568jGTmWUp9QMuCGLXIZNJLrnMJGOSKdRVF76BG5fio_gofRJze6vXQpEscjjn9z8nJ3-EXhA4IQDidQJgLa-A0go4YU3FH6EjwhmtCG3o43_iQ_Q0pQ0AEY3gT9Ahq2sQwMUR-v5R-SFM7osZsA4-xzCOJczRqRE7f2lSdmuVnV_jJRkcLE5LPy06pNv6xujsgt_mzy9NXDmbb77-LAUcVTZpm9dhmkeTDY4m7WkffDWbYfF6GQs5YH5z_a379WOa8BzGqzk9QwdWjck8v7uP0cWb809n76rVh7fvz05XlebQ5arres1Jp2ujO2Fp34JljNd90w-1bm1Lamo1NEL0thZMQ6db1QklAKDRQ8_YMXq16zvH8Hkp68pNWKIvIyVtBCNCCFLvqbUajXTehhyVnlzS8lRAQwitSVuokweocgYzufK7xrqSvyegO4GOIaVorJyjm1S8kgTk1mO581gWj-Wtx5IX0cu7FxcnzPBX8sfUArAdkErJr03cr_Sftr8BI361ig</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2673177715</pqid></control><display><type>article</type><title>Randomized controlled trial investigating use of submucosal injection of EverLift™ in rates of complete resection of non-pedunculated 4–9 mm polyps</title><source>SpringerLink Journals</source><creator>Wei, Mike T. ; Louie, Christine Y. ; Chen, Yu ; Pan, Jennifer Y. ; Quan, Susan Y. ; Wong, Robert ; Brown, Ryanne ; Clark, Melissa ; Jensen, Kristin ; Lau, Hubert ; Friedland, Shai</creator><creatorcontrib>Wei, Mike T. ; Louie, Christine Y. ; Chen, Yu ; Pan, Jennifer Y. ; Quan, Susan Y. ; Wong, Robert ; Brown, Ryanne ; Clark, Melissa ; Jensen, Kristin ; Lau, Hubert ; Friedland, Shai</creatorcontrib><description>Introduction
Currently, cold snare polypectomy (CSP) without submucosal injection is recommended for removing polyps < 10 mm. Use of viscous submucosal agents has not been previously evaluated in CSP. We investigate the potential role of EverLift™ (GI Supply, Pennsylvania) in CSP.
Methods
The study is a single-center prospective randomized non-inferiority clinical trial evaluating CSP of non-pedunculated 4–9 mm polyps, with or without submucosal injection of EverLift™. Patients 18–80 years of age presenting for colonoscopy were recruited. Eligible polyps underwent block randomization to CSP with or without EverLift™. Following CSP, two biopsies were performed at the CSP site margin. The primary non-inferiority outcome was complete resection rate, defined by absence of residual polyp in the margin biopsies (non-inferiority margin −10%).
Results
A total of 291 eligible polyps underwent CSP, with 142 removed using EverLift™. There was similar polyp size and distribution of pathology between the two groups. Overall, there was a low rate of positive margins with (1.4%) or without submucosal injection (2.8%), with no significant difference in complete resection (difference 1.28%, 95% CI: −2.66 to 5.42%), demonstrating non-inferiority of EverLift™ injection. Use of EverLift™ significantly increased CSP time (109.8 vs 38.8 s,
p
< 0.0001) and frequency of use of hemostatic clips (13.4 vs 3.6%,
p
= 0.002).
Conclusion
Submucosal injection of EverLift™ was non-inferior to CSP of 4–9 mm polyps without injection and increased time for resection as well as use of hemostatic clips to control acute bleeding. Our results suggest that polypectomy of 4–9 mm polyps can be safely performed without submucosal injection of EverLift™.</description><identifier>ISSN: 1432-1262</identifier><identifier>ISSN: 0179-1958</identifier><identifier>EISSN: 1432-1262</identifier><identifier>DOI: 10.1007/s00384-022-04136-4</identifier><identifier>PMID: 35507047</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Biopsy ; Clinical trials ; Colon ; Colonoscopy ; Gastroenterology ; Hepatology ; Injection ; Internal Medicine ; Medicine ; Medicine & Public Health ; Methylene blue ; Original Article ; Polyps ; Polyps (Pathology) ; Proctology ; Product development ; Surgery</subject><ispartof>International journal of colorectal disease, 2022-06, Vol.37 (6), p.1273-1279</ispartof><rights>The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2022</rights><rights>2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.</rights><rights>COPYRIGHT 2022 Springer</rights><rights>The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2022.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c409t-99bc419c5ec97f2b80f3345b6bd5c8f8152fc0677bf573c09c8a97a70006cdb33</citedby><cites>FETCH-LOGICAL-c409t-99bc419c5ec97f2b80f3345b6bd5c8f8152fc0677bf573c09c8a97a70006cdb33</cites><orcidid>0000-0003-4756-9010</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00384-022-04136-4$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00384-022-04136-4$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35507047$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Wei, Mike T.</creatorcontrib><creatorcontrib>Louie, Christine Y.</creatorcontrib><creatorcontrib>Chen, Yu</creatorcontrib><creatorcontrib>Pan, Jennifer Y.</creatorcontrib><creatorcontrib>Quan, Susan Y.</creatorcontrib><creatorcontrib>Wong, Robert</creatorcontrib><creatorcontrib>Brown, Ryanne</creatorcontrib><creatorcontrib>Clark, Melissa</creatorcontrib><creatorcontrib>Jensen, Kristin</creatorcontrib><creatorcontrib>Lau, Hubert</creatorcontrib><creatorcontrib>Friedland, Shai</creatorcontrib><title>Randomized controlled trial investigating use of submucosal injection of EverLift™ in rates of complete resection of non-pedunculated 4–9 mm polyps</title><title>International journal of colorectal disease</title><addtitle>Int J Colorectal Dis</addtitle><addtitle>Int J Colorectal Dis</addtitle><description>Introduction
Currently, cold snare polypectomy (CSP) without submucosal injection is recommended for removing polyps < 10 mm. Use of viscous submucosal agents has not been previously evaluated in CSP. We investigate the potential role of EverLift™ (GI Supply, Pennsylvania) in CSP.
Methods
The study is a single-center prospective randomized non-inferiority clinical trial evaluating CSP of non-pedunculated 4–9 mm polyps, with or without submucosal injection of EverLift™. Patients 18–80 years of age presenting for colonoscopy were recruited. Eligible polyps underwent block randomization to CSP with or without EverLift™. Following CSP, two biopsies were performed at the CSP site margin. The primary non-inferiority outcome was complete resection rate, defined by absence of residual polyp in the margin biopsies (non-inferiority margin −10%).
Results
A total of 291 eligible polyps underwent CSP, with 142 removed using EverLift™. There was similar polyp size and distribution of pathology between the two groups. Overall, there was a low rate of positive margins with (1.4%) or without submucosal injection (2.8%), with no significant difference in complete resection (difference 1.28%, 95% CI: −2.66 to 5.42%), demonstrating non-inferiority of EverLift™ injection. Use of EverLift™ significantly increased CSP time (109.8 vs 38.8 s,
p
< 0.0001) and frequency of use of hemostatic clips (13.4 vs 3.6%,
p
= 0.002).
Conclusion
Submucosal injection of EverLift™ was non-inferior to CSP of 4–9 mm polyps without injection and increased time for resection as well as use of hemostatic clips to control acute bleeding. Our results suggest that polypectomy of 4–9 mm polyps can be safely performed without submucosal injection of EverLift™.</description><subject>Biopsy</subject><subject>Clinical trials</subject><subject>Colon</subject><subject>Colonoscopy</subject><subject>Gastroenterology</subject><subject>Hepatology</subject><subject>Injection</subject><subject>Internal Medicine</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Methylene blue</subject><subject>Original Article</subject><subject>Polyps</subject><subject>Polyps (Pathology)</subject><subject>Proctology</subject><subject>Product development</subject><subject>Surgery</subject><issn>1432-1262</issn><issn>0179-1958</issn><issn>1432-1262</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><recordid>eNp9kc1qFTEUx4NYbK2-gAsJuJ568jGTmWUp9QMuCGLXIZNJLrnMJGOSKdRVF76BG5fio_gofRJze6vXQpEscjjn9z8nJ3-EXhA4IQDidQJgLa-A0go4YU3FH6EjwhmtCG3o43_iQ_Q0pQ0AEY3gT9Ahq2sQwMUR-v5R-SFM7osZsA4-xzCOJczRqRE7f2lSdmuVnV_jJRkcLE5LPy06pNv6xujsgt_mzy9NXDmbb77-LAUcVTZpm9dhmkeTDY4m7WkffDWbYfF6GQs5YH5z_a379WOa8BzGqzk9QwdWjck8v7uP0cWb809n76rVh7fvz05XlebQ5arres1Jp2ujO2Fp34JljNd90w-1bm1Lamo1NEL0thZMQ6db1QklAKDRQ8_YMXq16zvH8Hkp68pNWKIvIyVtBCNCCFLvqbUajXTehhyVnlzS8lRAQwitSVuokweocgYzufK7xrqSvyegO4GOIaVorJyjm1S8kgTk1mO581gWj-Wtx5IX0cu7FxcnzPBX8sfUArAdkErJr03cr_Sftr8BI361ig</recordid><startdate>20220601</startdate><enddate>20220601</enddate><creator>Wei, Mike T.</creator><creator>Louie, Christine Y.</creator><creator>Chen, Yu</creator><creator>Pan, Jennifer Y.</creator><creator>Quan, Susan Y.</creator><creator>Wong, Robert</creator><creator>Brown, Ryanne</creator><creator>Clark, Melissa</creator><creator>Jensen, Kristin</creator><creator>Lau, Hubert</creator><creator>Friedland, Shai</creator><general>Springer Berlin Heidelberg</general><general>Springer</general><general>Springer Nature B.V</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>H94</scope><scope>K9.</scope><orcidid>https://orcid.org/0000-0003-4756-9010</orcidid></search><sort><creationdate>20220601</creationdate><title>Randomized controlled trial investigating use of submucosal injection of EverLift™ in rates of complete resection of non-pedunculated 4–9 mm polyps</title><author>Wei, Mike T. ; Louie, Christine Y. ; Chen, Yu ; Pan, Jennifer Y. ; Quan, Susan Y. ; Wong, Robert ; Brown, Ryanne ; Clark, Melissa ; Jensen, Kristin ; Lau, Hubert ; Friedland, Shai</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c409t-99bc419c5ec97f2b80f3345b6bd5c8f8152fc0677bf573c09c8a97a70006cdb33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Biopsy</topic><topic>Clinical trials</topic><topic>Colon</topic><topic>Colonoscopy</topic><topic>Gastroenterology</topic><topic>Hepatology</topic><topic>Injection</topic><topic>Internal Medicine</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Methylene blue</topic><topic>Original Article</topic><topic>Polyps</topic><topic>Polyps (Pathology)</topic><topic>Proctology</topic><topic>Product development</topic><topic>Surgery</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Wei, Mike T.</creatorcontrib><creatorcontrib>Louie, Christine Y.</creatorcontrib><creatorcontrib>Chen, Yu</creatorcontrib><creatorcontrib>Pan, Jennifer Y.</creatorcontrib><creatorcontrib>Quan, Susan Y.</creatorcontrib><creatorcontrib>Wong, Robert</creatorcontrib><creatorcontrib>Brown, Ryanne</creatorcontrib><creatorcontrib>Clark, Melissa</creatorcontrib><creatorcontrib>Jensen, Kristin</creatorcontrib><creatorcontrib>Lau, Hubert</creatorcontrib><creatorcontrib>Friedland, Shai</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><jtitle>International journal of colorectal disease</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Wei, Mike T.</au><au>Louie, Christine Y.</au><au>Chen, Yu</au><au>Pan, Jennifer Y.</au><au>Quan, Susan Y.</au><au>Wong, Robert</au><au>Brown, Ryanne</au><au>Clark, Melissa</au><au>Jensen, Kristin</au><au>Lau, Hubert</au><au>Friedland, Shai</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized controlled trial investigating use of submucosal injection of EverLift™ in rates of complete resection of non-pedunculated 4–9 mm polyps</atitle><jtitle>International journal of colorectal disease</jtitle><stitle>Int J Colorectal Dis</stitle><addtitle>Int J Colorectal Dis</addtitle><date>2022-06-01</date><risdate>2022</risdate><volume>37</volume><issue>6</issue><spage>1273</spage><epage>1279</epage><pages>1273-1279</pages><issn>1432-1262</issn><issn>0179-1958</issn><eissn>1432-1262</eissn><abstract>Introduction
Currently, cold snare polypectomy (CSP) without submucosal injection is recommended for removing polyps < 10 mm. Use of viscous submucosal agents has not been previously evaluated in CSP. We investigate the potential role of EverLift™ (GI Supply, Pennsylvania) in CSP.
Methods
The study is a single-center prospective randomized non-inferiority clinical trial evaluating CSP of non-pedunculated 4–9 mm polyps, with or without submucosal injection of EverLift™. Patients 18–80 years of age presenting for colonoscopy were recruited. Eligible polyps underwent block randomization to CSP with or without EverLift™. Following CSP, two biopsies were performed at the CSP site margin. The primary non-inferiority outcome was complete resection rate, defined by absence of residual polyp in the margin biopsies (non-inferiority margin −10%).
Results
A total of 291 eligible polyps underwent CSP, with 142 removed using EverLift™. There was similar polyp size and distribution of pathology between the two groups. Overall, there was a low rate of positive margins with (1.4%) or without submucosal injection (2.8%), with no significant difference in complete resection (difference 1.28%, 95% CI: −2.66 to 5.42%), demonstrating non-inferiority of EverLift™ injection. Use of EverLift™ significantly increased CSP time (109.8 vs 38.8 s,
p
< 0.0001) and frequency of use of hemostatic clips (13.4 vs 3.6%,
p
= 0.002).
Conclusion
Submucosal injection of EverLift™ was non-inferior to CSP of 4–9 mm polyps without injection and increased time for resection as well as use of hemostatic clips to control acute bleeding. Our results suggest that polypectomy of 4–9 mm polyps can be safely performed without submucosal injection of EverLift™.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>35507047</pmid><doi>10.1007/s00384-022-04136-4</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0003-4756-9010</orcidid></addata></record> |
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| subjects | Biopsy Clinical trials Colon Colonoscopy Gastroenterology Hepatology Injection Internal Medicine Medicine Medicine & Public Health Methylene blue Original Article Polyps Polyps (Pathology) Proctology Product development Surgery |
| title | Randomized controlled trial investigating use of submucosal injection of EverLift™ in rates of complete resection of non-pedunculated 4–9 mm polyps |
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