A prospective, randomized trial of esophageal submucosal tunnel closure with a stent versus no closure to secure a transesophageal natural orifice transluminal endoscopic surgery access site

Background Secure esophagotomy closure methods are a critical element in the advancement of transesophageal natural orifice transluminal endoscopic surgery (NOTES) procedures. Objective To compare the clinical outcomes in swine receiving an esophageal stent or no stent after a submucosal tunnel NOTE...

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Veröffentlicht in:Gastrointestinal endoscopy 2011-04, Vol.73 (4), p.785-790
Hauptverfasser: Turner, Brian G., MD, Kim, Min-Chan, MD, Gee, Denise W., MD, Dursun, Abdulmetin, MD, Mino-Kenudson, Mari, MD, Huang, Edward S., MD, Sylla, Patricia, MD, Rattner, David W., MD, Brugge, William R., MD, FASGE
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container_end_page 790
container_issue 4
container_start_page 785
container_title Gastrointestinal endoscopy
container_volume 73
creator Turner, Brian G., MD
Kim, Min-Chan, MD
Gee, Denise W., MD
Dursun, Abdulmetin, MD
Mino-Kenudson, Mari, MD
Huang, Edward S., MD
Sylla, Patricia, MD
Rattner, David W., MD
Brugge, William R., MD, FASGE
description Background Secure esophagotomy closure methods are a critical element in the advancement of transesophageal natural orifice transluminal endoscopic surgery (NOTES) procedures. Objective To compare the clinical outcomes in swine receiving an esophageal stent or no stent after a submucosal tunnel NOTES access procedure. Design Prospective, randomized, controlled trial in 10 Yorkshire swine. Setting Academic center. Intervention An endoscopic mucosectomy device was used to create an esophageal mucosal defect. An endoscope was advanced through a submucosal tunnel into the mediastinum and thorax, and diagnostic mediastinoscopy and thoracoscopy were performed. Ten animals were randomized to no stenting (n = 5) or stenting (n = 5) with a prototype small-intestine submucosa–covered stent. Main Outcome Measurements Gross and histologic appearance of the mucosectomy and esophagotomy sites as well as clinical outcomes. Results There was a significant difference in the overall procedure time between the animals that received a stent (35.0 min, range 27-46.0 min) and those with no closure (19.0 min, range 17-32 min) ( P value = .018). The unstented group achieved endoscopic and histologic evidence of complete re-epithelialization and healing (100%) at the mucosectomy site compared with the stented group (20%, P = .048). Stent migration into the stomach occurred in two swine. Both groups had complete closure of the submucosal tunnel and well-healed esophagotomy sites. Limitations Animal study, small number of subjects. Conclusion The placement of a covered esophageal stent significantly interferes with mucosectomy site healing.
doi_str_mv 10.1016/j.gie.2010.11.025
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Objective To compare the clinical outcomes in swine receiving an esophageal stent or no stent after a submucosal tunnel NOTES access procedure. Design Prospective, randomized, controlled trial in 10 Yorkshire swine. Setting Academic center. Intervention An endoscopic mucosectomy device was used to create an esophageal mucosal defect. An endoscope was advanced through a submucosal tunnel into the mediastinum and thorax, and diagnostic mediastinoscopy and thoracoscopy were performed. Ten animals were randomized to no stenting (n = 5) or stenting (n = 5) with a prototype small-intestine submucosa–covered stent. Main Outcome Measurements Gross and histologic appearance of the mucosectomy and esophagotomy sites as well as clinical outcomes. Results There was a significant difference in the overall procedure time between the animals that received a stent (35.0 min, range 27-46.0 min) and those with no closure (19.0 min, range 17-32 min) ( P value = .018). The unstented group achieved endoscopic and histologic evidence of complete re-epithelialization and healing (100%) at the mucosectomy site compared with the stented group (20%, P = .048). Stent migration into the stomach occurred in two swine. Both groups had complete closure of the submucosal tunnel and well-healed esophagotomy sites. Limitations Animal study, small number of subjects. Conclusion The placement of a covered esophageal stent significantly interferes with mucosectomy site healing.</description><identifier>ISSN: 0016-5107</identifier><identifier>EISSN: 1097-6779</identifier><identifier>DOI: 10.1016/j.gie.2010.11.025</identifier><identifier>PMID: 21288511</identifier><identifier>CODEN: GAENBQ</identifier><language>eng</language><publisher>Maryland heights, MO: Mosby, Inc</publisher><subject>Animals ; Biological and medical sciences ; Digestive system. Abdomen ; Disease Models, Animal ; Dissection - methods ; Endoscopy ; Esophagus - surgery ; Follow-Up Studies ; Gastroenterology and Hepatology ; Gastroenterology. Liver. Pancreas. Abdomen ; Intestinal Mucosa - surgery ; Investigative techniques, diagnostic techniques (general aspects) ; Mediastinoscopy - adverse effects ; Medical sciences ; Natural Orifice Endoscopic Surgery - methods ; Postoperative Care - methods ; Prospective Studies ; Random Allocation ; Stents ; Swine ; Thoracoscopy - adverse effects ; Treatment Outcome</subject><ispartof>Gastrointestinal endoscopy, 2011-04, Vol.73 (4), p.785-790</ispartof><rights>American Society for Gastrointestinal Endoscopy</rights><rights>2011 American Society for Gastrointestinal Endoscopy</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. 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Objective To compare the clinical outcomes in swine receiving an esophageal stent or no stent after a submucosal tunnel NOTES access procedure. Design Prospective, randomized, controlled trial in 10 Yorkshire swine. Setting Academic center. Intervention An endoscopic mucosectomy device was used to create an esophageal mucosal defect. An endoscope was advanced through a submucosal tunnel into the mediastinum and thorax, and diagnostic mediastinoscopy and thoracoscopy were performed. Ten animals were randomized to no stenting (n = 5) or stenting (n = 5) with a prototype small-intestine submucosa–covered stent. Main Outcome Measurements Gross and histologic appearance of the mucosectomy and esophagotomy sites as well as clinical outcomes. Results There was a significant difference in the overall procedure time between the animals that received a stent (35.0 min, range 27-46.0 min) and those with no closure (19.0 min, range 17-32 min) ( P value = .018). The unstented group achieved endoscopic and histologic evidence of complete re-epithelialization and healing (100%) at the mucosectomy site compared with the stented group (20%, P = .048). Stent migration into the stomach occurred in two swine. Both groups had complete closure of the submucosal tunnel and well-healed esophagotomy sites. Limitations Animal study, small number of subjects. Conclusion The placement of a covered esophageal stent significantly interferes with mucosectomy site healing.</description><subject>Animals</subject><subject>Biological and medical sciences</subject><subject>Digestive system. Abdomen</subject><subject>Disease Models, Animal</subject><subject>Dissection - methods</subject><subject>Endoscopy</subject><subject>Esophagus - surgery</subject><subject>Follow-Up Studies</subject><subject>Gastroenterology and Hepatology</subject><subject>Gastroenterology. Liver. Pancreas. 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Abdomen</topic><topic>Disease Models, Animal</topic><topic>Dissection - methods</topic><topic>Endoscopy</topic><topic>Esophagus - surgery</topic><topic>Follow-Up Studies</topic><topic>Gastroenterology and Hepatology</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Intestinal Mucosa - surgery</topic><topic>Investigative techniques, diagnostic techniques (general aspects)</topic><topic>Mediastinoscopy - adverse effects</topic><topic>Medical sciences</topic><topic>Natural Orifice Endoscopic Surgery - methods</topic><topic>Postoperative Care - methods</topic><topic>Prospective Studies</topic><topic>Random Allocation</topic><topic>Stents</topic><topic>Swine</topic><topic>Thoracoscopy - adverse effects</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Turner, Brian G., MD</creatorcontrib><creatorcontrib>Kim, Min-Chan, MD</creatorcontrib><creatorcontrib>Gee, Denise W., MD</creatorcontrib><creatorcontrib>Dursun, Abdulmetin, MD</creatorcontrib><creatorcontrib>Mino-Kenudson, Mari, MD</creatorcontrib><creatorcontrib>Huang, Edward S., MD</creatorcontrib><creatorcontrib>Sylla, Patricia, MD</creatorcontrib><creatorcontrib>Rattner, David W., MD</creatorcontrib><creatorcontrib>Brugge, William R., MD, FASGE</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Gastrointestinal endoscopy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Turner, Brian G., MD</au><au>Kim, Min-Chan, MD</au><au>Gee, Denise W., MD</au><au>Dursun, Abdulmetin, MD</au><au>Mino-Kenudson, Mari, MD</au><au>Huang, Edward S., MD</au><au>Sylla, Patricia, MD</au><au>Rattner, David W., MD</au><au>Brugge, William R., MD, FASGE</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A prospective, randomized trial of esophageal submucosal tunnel closure with a stent versus no closure to secure a transesophageal natural orifice transluminal endoscopic surgery access site</atitle><jtitle>Gastrointestinal endoscopy</jtitle><addtitle>Gastrointest Endosc</addtitle><date>2011-04-01</date><risdate>2011</risdate><volume>73</volume><issue>4</issue><spage>785</spage><epage>790</epage><pages>785-790</pages><issn>0016-5107</issn><eissn>1097-6779</eissn><coden>GAENBQ</coden><abstract>Background Secure esophagotomy closure methods are a critical element in the advancement of transesophageal natural orifice transluminal endoscopic surgery (NOTES) procedures. Objective To compare the clinical outcomes in swine receiving an esophageal stent or no stent after a submucosal tunnel NOTES access procedure. Design Prospective, randomized, controlled trial in 10 Yorkshire swine. Setting Academic center. Intervention An endoscopic mucosectomy device was used to create an esophageal mucosal defect. An endoscope was advanced through a submucosal tunnel into the mediastinum and thorax, and diagnostic mediastinoscopy and thoracoscopy were performed. Ten animals were randomized to no stenting (n = 5) or stenting (n = 5) with a prototype small-intestine submucosa–covered stent. Main Outcome Measurements Gross and histologic appearance of the mucosectomy and esophagotomy sites as well as clinical outcomes. Results There was a significant difference in the overall procedure time between the animals that received a stent (35.0 min, range 27-46.0 min) and those with no closure (19.0 min, range 17-32 min) ( P value = .018). The unstented group achieved endoscopic and histologic evidence of complete re-epithelialization and healing (100%) at the mucosectomy site compared with the stented group (20%, P = .048). Stent migration into the stomach occurred in two swine. Both groups had complete closure of the submucosal tunnel and well-healed esophagotomy sites. Limitations Animal study, small number of subjects. Conclusion The placement of a covered esophageal stent significantly interferes with mucosectomy site healing.</abstract><cop>Maryland heights, MO</cop><pub>Mosby, Inc</pub><pmid>21288511</pmid><doi>10.1016/j.gie.2010.11.025</doi><tpages>6</tpages></addata></record>
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ispartof Gastrointestinal endoscopy, 2011-04, Vol.73 (4), p.785-790
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source MEDLINE; Elsevier ScienceDirect Journals
subjects Animals
Biological and medical sciences
Digestive system. Abdomen
Disease Models, Animal
Dissection - methods
Endoscopy
Esophagus - surgery
Follow-Up Studies
Gastroenterology and Hepatology
Gastroenterology. Liver. Pancreas. Abdomen
Intestinal Mucosa - surgery
Investigative techniques, diagnostic techniques (general aspects)
Mediastinoscopy - adverse effects
Medical sciences
Natural Orifice Endoscopic Surgery - methods
Postoperative Care - methods
Prospective Studies
Random Allocation
Stents
Swine
Thoracoscopy - adverse effects
Treatment Outcome
title A prospective, randomized trial of esophageal submucosal tunnel closure with a stent versus no closure to secure a transesophageal natural orifice transluminal endoscopic surgery access site
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