Loading…

Single session per oral endoscopic myotomy and trans oral incisionless fundoplication – can we prevent reflux in patients with achalasia?

Abstract Background and study aims  The rate of gastroesophageal reflux disease (GERD) after per oral endoscopic myotomy (POEM) is concerning. Endoscopic anti-reflux methods, such as Trans Oral Incisionless Fundoplication (TIF), are crucial for the long-term success of POEM, especially if they can b...

Full description

Saved in:
Bibliographic Details
Published in:Endoscopy International Open 2021-06, Vol.9 (6), p.E828-E835
Main Authors: Benias, Petros C., Kumbhari, Vivek, Kumta, Nikhil A., Sethi, Amrita, D’Souza, Lionel S., Tyberg, Amy, Brewer Gutierrez, Olaya, Miller, Larry S., Carr-Locke, David L., Khashab, Mouen A.
Format: Article
Language:English
Subjects:
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
cited_by cdi_FETCH-LOGICAL-c389t-4b74ea38cb2a3aa2d123618ace22b967b3543e6b944a9dc27b00c22863b8e3e03
cites cdi_FETCH-LOGICAL-c389t-4b74ea38cb2a3aa2d123618ace22b967b3543e6b944a9dc27b00c22863b8e3e03
container_end_page E835
container_issue 6
container_start_page E828
container_title Endoscopy International Open
container_volume 9
creator Benias, Petros C.
Kumbhari, Vivek
Kumta, Nikhil A.
Sethi, Amrita
D’Souza, Lionel S.
Tyberg, Amy
Brewer Gutierrez, Olaya
Miller, Larry S.
Carr-Locke, David L.
Khashab, Mouen A.
description Abstract Background and study aims  The rate of gastroesophageal reflux disease (GERD) after per oral endoscopic myotomy (POEM) is concerning. Endoscopic anti-reflux methods, such as Trans Oral Incisionless Fundoplication (TIF), are crucial for the long-term success of POEM, especially if they can be performed in the same session. Methods  We completed a proof-of-concept canine pilot study (n = 6) to assess safety and feasibility of POEM and TIF in a single session (POEM-TIF). Subsequently, POEM-TIF was also performed in patients with achalasia (n = 5). Herein, we report on the safety, technical and clinical success of the first-in-human cases with symptom follow-up at 1, 3 and 6 months and pH testing at 6 months. Results  POEM was completed successfully in six canines (3 anterior and 3 posterior myotomies), followed by TIF in the same session. Necropsy and extensive testing demonstrated no evidence of mucosal injury and no leaks. The reconstructed valve was 220 to 240 degrees, 3 to 4 cm in length, and resulted in concomitant esophageal lengthening (2–5 cm). Using similar principles, the first-in-human cases were performed without intraprocedural or delayed adverse events. pH testing at 6 months showed that four of five patients had no evidence of GERD (DeMeester > 14.72), and in one case, there was evidence of esophagitis. Conclusions  Single session POEM-TIF appears to be safe and feasible. Early clinical human data suggests that it may be able to reduce post POEM GERD, however the additional secondary benefits such as lengthening and straightening of the esophagus, may prove to be equally important for the long-term success of POEM.
doi_str_mv 10.1055/a-1395-5667
format article
fullrecord <record><control><sourceid>thieme_doaj_</sourceid><recordid>TN_cdi_doaj_primary_oai_doaj_org_article_5e98f478ea9b4442af1a9d86ea223fb8</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><doaj_id>oai_doaj_org_article_5e98f478ea9b4442af1a9d86ea223fb8</doaj_id><sourcerecordid>10_1055_a_1395_5667</sourcerecordid><originalsourceid>FETCH-LOGICAL-c389t-4b74ea38cb2a3aa2d123618ace22b967b3543e6b944a9dc27b00c22863b8e3e03</originalsourceid><addsrcrecordid>eNptkU-L1TAUxYsozjDOyi-QtVLNv6bJRpHBPwMDLtR1uE1v38ujTUrSNzNv596l39BPYmpFGHCVcO85PzjnVtVzRl8x2jSvoWbCNHWjVPuoOufMqNq0Qj0uf6FkLVrOz6rLnA-UUiak5Eo_rc6EpK3RSpxXP774sBuRZMzZx0BmTCQmGAmGPmYXZ-_IdIpLnE4EQk-WBCFvCh-cXz1jsZLhWPTz6B0sK-bX95_EQSB3SOaEtxgWknAYj_fFReaiKZNM7vyyJ-D2MEL28PZZ9WSAMePl3_ei-vbh_derT_XN54_XV-9uaie0WWrZtRJBaNdxEAC8ZyUq0-CQ886othONFKg6IyWY3vG2o9RxXuJ2GgVScVFdb9w-wsHOyU-QTjaCt38GMe0spMW7EW2DRg-y1Qimk6U9GFhhaoXAuRg6XVhvNtZ87CbsXclVunkAfbgJfm938dZq1hjFmgJ4uQFcijmXkv55GbXriS3Y9cR2PXFRv9jUy97jhPYQjymUrv4r_g2Qtan4</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Single session per oral endoscopic myotomy and trans oral incisionless fundoplication – can we prevent reflux in patients with achalasia?</title><source>Open Access: PubMed Central</source><source>Open Access: Thieme Open Access Journals</source><creator>Benias, Petros C. ; Kumbhari, Vivek ; Kumta, Nikhil A. ; Sethi, Amrita ; D’Souza, Lionel S. ; Tyberg, Amy ; Brewer Gutierrez, Olaya ; Miller, Larry S. ; Carr-Locke, David L. ; Khashab, Mouen A.</creator><creatorcontrib>Benias, Petros C. ; Kumbhari, Vivek ; Kumta, Nikhil A. ; Sethi, Amrita ; D’Souza, Lionel S. ; Tyberg, Amy ; Brewer Gutierrez, Olaya ; Miller, Larry S. ; Carr-Locke, David L. ; Khashab, Mouen A.</creatorcontrib><description>Abstract Background and study aims  The rate of gastroesophageal reflux disease (GERD) after per oral endoscopic myotomy (POEM) is concerning. Endoscopic anti-reflux methods, such as Trans Oral Incisionless Fundoplication (TIF), are crucial for the long-term success of POEM, especially if they can be performed in the same session. Methods  We completed a proof-of-concept canine pilot study (n = 6) to assess safety and feasibility of POEM and TIF in a single session (POEM-TIF). Subsequently, POEM-TIF was also performed in patients with achalasia (n = 5). Herein, we report on the safety, technical and clinical success of the first-in-human cases with symptom follow-up at 1, 3 and 6 months and pH testing at 6 months. Results  POEM was completed successfully in six canines (3 anterior and 3 posterior myotomies), followed by TIF in the same session. Necropsy and extensive testing demonstrated no evidence of mucosal injury and no leaks. The reconstructed valve was 220 to 240 degrees, 3 to 4 cm in length, and resulted in concomitant esophageal lengthening (2–5 cm). Using similar principles, the first-in-human cases were performed without intraprocedural or delayed adverse events. pH testing at 6 months showed that four of five patients had no evidence of GERD (DeMeester &gt; 14.72), and in one case, there was evidence of esophagitis. Conclusions  Single session POEM-TIF appears to be safe and feasible. Early clinical human data suggests that it may be able to reduce post POEM GERD, however the additional secondary benefits such as lengthening and straightening of the esophagus, may prove to be equally important for the long-term success of POEM.</description><identifier>ISSN: 2364-3722</identifier><identifier>EISSN: 2196-9736</identifier><identifier>DOI: 10.1055/a-1395-5667</identifier><identifier>PMID: 34079863</identifier><language>eng</language><publisher>Rüdigerstraße 14, 70469 Stuttgart, Germany: Georg Thieme Verlag KG</publisher><subject>Original article</subject><ispartof>Endoscopy International Open, 2021-06, Vol.9 (6), p.E828-E835</ispartof><rights>The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)</rights><rights>The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/) 2021 The Author(s).</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c389t-4b74ea38cb2a3aa2d123618ace22b967b3543e6b944a9dc27b00c22863b8e3e03</citedby><cites>FETCH-LOGICAL-c389t-4b74ea38cb2a3aa2d123618ace22b967b3543e6b944a9dc27b00c22863b8e3e03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8159615/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8159615/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,20891,27924,27925,53791,53793,54587,54615</link.rule.ids></links><search><creatorcontrib>Benias, Petros C.</creatorcontrib><creatorcontrib>Kumbhari, Vivek</creatorcontrib><creatorcontrib>Kumta, Nikhil A.</creatorcontrib><creatorcontrib>Sethi, Amrita</creatorcontrib><creatorcontrib>D’Souza, Lionel S.</creatorcontrib><creatorcontrib>Tyberg, Amy</creatorcontrib><creatorcontrib>Brewer Gutierrez, Olaya</creatorcontrib><creatorcontrib>Miller, Larry S.</creatorcontrib><creatorcontrib>Carr-Locke, David L.</creatorcontrib><creatorcontrib>Khashab, Mouen A.</creatorcontrib><title>Single session per oral endoscopic myotomy and trans oral incisionless fundoplication – can we prevent reflux in patients with achalasia?</title><title>Endoscopy International Open</title><addtitle>Endosc Int Open</addtitle><description>Abstract Background and study aims  The rate of gastroesophageal reflux disease (GERD) after per oral endoscopic myotomy (POEM) is concerning. Endoscopic anti-reflux methods, such as Trans Oral Incisionless Fundoplication (TIF), are crucial for the long-term success of POEM, especially if they can be performed in the same session. Methods  We completed a proof-of-concept canine pilot study (n = 6) to assess safety and feasibility of POEM and TIF in a single session (POEM-TIF). Subsequently, POEM-TIF was also performed in patients with achalasia (n = 5). Herein, we report on the safety, technical and clinical success of the first-in-human cases with symptom follow-up at 1, 3 and 6 months and pH testing at 6 months. Results  POEM was completed successfully in six canines (3 anterior and 3 posterior myotomies), followed by TIF in the same session. Necropsy and extensive testing demonstrated no evidence of mucosal injury and no leaks. The reconstructed valve was 220 to 240 degrees, 3 to 4 cm in length, and resulted in concomitant esophageal lengthening (2–5 cm). Using similar principles, the first-in-human cases were performed without intraprocedural or delayed adverse events. pH testing at 6 months showed that four of five patients had no evidence of GERD (DeMeester &gt; 14.72), and in one case, there was evidence of esophagitis. Conclusions  Single session POEM-TIF appears to be safe and feasible. Early clinical human data suggests that it may be able to reduce post POEM GERD, however the additional secondary benefits such as lengthening and straightening of the esophagus, may prove to be equally important for the long-term success of POEM.</description><subject>Original article</subject><issn>2364-3722</issn><issn>2196-9736</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>0U6</sourceid><sourceid>DOA</sourceid><recordid>eNptkU-L1TAUxYsozjDOyi-QtVLNv6bJRpHBPwMDLtR1uE1v38ujTUrSNzNv596l39BPYmpFGHCVcO85PzjnVtVzRl8x2jSvoWbCNHWjVPuoOufMqNq0Qj0uf6FkLVrOz6rLnA-UUiak5Eo_rc6EpK3RSpxXP774sBuRZMzZx0BmTCQmGAmGPmYXZ-_IdIpLnE4EQk-WBCFvCh-cXz1jsZLhWPTz6B0sK-bX95_EQSB3SOaEtxgWknAYj_fFReaiKZNM7vyyJ-D2MEL28PZZ9WSAMePl3_ei-vbh_derT_XN54_XV-9uaie0WWrZtRJBaNdxEAC8ZyUq0-CQ886othONFKg6IyWY3vG2o9RxXuJ2GgVScVFdb9w-wsHOyU-QTjaCt38GMe0spMW7EW2DRg-y1Qimk6U9GFhhaoXAuRg6XVhvNtZ87CbsXclVunkAfbgJfm938dZq1hjFmgJ4uQFcijmXkv55GbXriS3Y9cR2PXFRv9jUy97jhPYQjymUrv4r_g2Qtan4</recordid><startdate>20210601</startdate><enddate>20210601</enddate><creator>Benias, Petros C.</creator><creator>Kumbhari, Vivek</creator><creator>Kumta, Nikhil A.</creator><creator>Sethi, Amrita</creator><creator>D’Souza, Lionel S.</creator><creator>Tyberg, Amy</creator><creator>Brewer Gutierrez, Olaya</creator><creator>Miller, Larry S.</creator><creator>Carr-Locke, David L.</creator><creator>Khashab, Mouen A.</creator><general>Georg Thieme Verlag KG</general><scope>0U6</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20210601</creationdate><title>Single session per oral endoscopic myotomy and trans oral incisionless fundoplication – can we prevent reflux in patients with achalasia?</title><author>Benias, Petros C. ; Kumbhari, Vivek ; Kumta, Nikhil A. ; Sethi, Amrita ; D’Souza, Lionel S. ; Tyberg, Amy ; Brewer Gutierrez, Olaya ; Miller, Larry S. ; Carr-Locke, David L. ; Khashab, Mouen A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c389t-4b74ea38cb2a3aa2d123618ace22b967b3543e6b944a9dc27b00c22863b8e3e03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Original article</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Benias, Petros C.</creatorcontrib><creatorcontrib>Kumbhari, Vivek</creatorcontrib><creatorcontrib>Kumta, Nikhil A.</creatorcontrib><creatorcontrib>Sethi, Amrita</creatorcontrib><creatorcontrib>D’Souza, Lionel S.</creatorcontrib><creatorcontrib>Tyberg, Amy</creatorcontrib><creatorcontrib>Brewer Gutierrez, Olaya</creatorcontrib><creatorcontrib>Miller, Larry S.</creatorcontrib><creatorcontrib>Carr-Locke, David L.</creatorcontrib><creatorcontrib>Khashab, Mouen A.</creatorcontrib><collection>Open Access: Thieme Open Access Journals</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><collection>Directory of Open Access Journals</collection><jtitle>Endoscopy International Open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Benias, Petros C.</au><au>Kumbhari, Vivek</au><au>Kumta, Nikhil A.</au><au>Sethi, Amrita</au><au>D’Souza, Lionel S.</au><au>Tyberg, Amy</au><au>Brewer Gutierrez, Olaya</au><au>Miller, Larry S.</au><au>Carr-Locke, David L.</au><au>Khashab, Mouen A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Single session per oral endoscopic myotomy and trans oral incisionless fundoplication – can we prevent reflux in patients with achalasia?</atitle><jtitle>Endoscopy International Open</jtitle><addtitle>Endosc Int Open</addtitle><date>2021-06-01</date><risdate>2021</risdate><volume>9</volume><issue>6</issue><spage>E828</spage><epage>E835</epage><pages>E828-E835</pages><issn>2364-3722</issn><eissn>2196-9736</eissn><abstract>Abstract Background and study aims  The rate of gastroesophageal reflux disease (GERD) after per oral endoscopic myotomy (POEM) is concerning. Endoscopic anti-reflux methods, such as Trans Oral Incisionless Fundoplication (TIF), are crucial for the long-term success of POEM, especially if they can be performed in the same session. Methods  We completed a proof-of-concept canine pilot study (n = 6) to assess safety and feasibility of POEM and TIF in a single session (POEM-TIF). Subsequently, POEM-TIF was also performed in patients with achalasia (n = 5). Herein, we report on the safety, technical and clinical success of the first-in-human cases with symptom follow-up at 1, 3 and 6 months and pH testing at 6 months. Results  POEM was completed successfully in six canines (3 anterior and 3 posterior myotomies), followed by TIF in the same session. Necropsy and extensive testing demonstrated no evidence of mucosal injury and no leaks. The reconstructed valve was 220 to 240 degrees, 3 to 4 cm in length, and resulted in concomitant esophageal lengthening (2–5 cm). Using similar principles, the first-in-human cases were performed without intraprocedural or delayed adverse events. pH testing at 6 months showed that four of five patients had no evidence of GERD (DeMeester &gt; 14.72), and in one case, there was evidence of esophagitis. Conclusions  Single session POEM-TIF appears to be safe and feasible. Early clinical human data suggests that it may be able to reduce post POEM GERD, however the additional secondary benefits such as lengthening and straightening of the esophagus, may prove to be equally important for the long-term success of POEM.</abstract><cop>Rüdigerstraße 14, 70469 Stuttgart, Germany</cop><pub>Georg Thieme Verlag KG</pub><pmid>34079863</pmid><doi>10.1055/a-1395-5667</doi><oa>free_for_read</oa></addata></record>
fulltext fulltext
identifier ISSN: 2364-3722
ispartof Endoscopy International Open, 2021-06, Vol.9 (6), p.E828-E835
issn 2364-3722
2196-9736
language eng
recordid cdi_doaj_primary_oai_doaj_org_article_5e98f478ea9b4442af1a9d86ea223fb8
source Open Access: PubMed Central; Open Access: Thieme Open Access Journals
subjects Original article
title Single session per oral endoscopic myotomy and trans oral incisionless fundoplication – can we prevent reflux in patients with achalasia?
url http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-25T11%3A03%3A37IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-thieme_doaj_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Single%20session%20per%20oral%20endoscopic%20myotomy%20and%20trans%20oral%20incisionless%20fundoplication%20%E2%80%93%20can%20we%20prevent%20reflux%20in%20patients%20with%20achalasia?&rft.jtitle=Endoscopy%20International%20Open&rft.au=Benias,%20Petros%20C.&rft.date=2021-06-01&rft.volume=9&rft.issue=6&rft.spage=E828&rft.epage=E835&rft.pages=E828-E835&rft.issn=2364-3722&rft.eissn=2196-9736&rft_id=info:doi/10.1055/a-1395-5667&rft_dat=%3Cthieme_doaj_%3E10_1055_a_1395_5667%3C/thieme_doaj_%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-c389t-4b74ea38cb2a3aa2d123618ace22b967b3543e6b944a9dc27b00c22863b8e3e03%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_id=info:pmid/34079863&rfr_iscdi=true