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The Effect of Botulinum Toxin Type A Injections on Stricture Formation, Leakage Rates, Esophageal Elongation, and Anastomotic Healing Following Primary Anastomosis in a Long- and Short-Gap Esophageal Atresia Model : A Protocol for a Randomized, Controlled, Blinded Trial in Pigs

Svensson, Emma LU orcid ; Zvara, Peter ; Qvist, Niels ; Hagander, Lars LU orcid ; Möller, Sören ; Rasmussen, Lars ; Daa Schrøder, Henrik ; Kildall Hejböl, Eva ; Björn, Niels and Petersen, Susanna , et al. (2021) In International Journal of Surgery Protocols 25(1). p.171-177
Abstract
Background:
Esophageal atresia (EA) is a congenital malformation affecting 1:3000-4500 newborns. Approximately 15% have a long-gap EA (LGEA), in which case a primary anastomosis is often impossible to achieve. To create continuity of the esophagus patients instead have to undergo lengthening procedures or organ interpositions; methods associated with high morbidity and poor functional outcomes. Esophageal injections of Botulinum Toxin Type A (BTX-A) could enable primary anastomosis and mitigate stricture formation through decreased tissue tension.

Methods and Analysis:
In this randomized controlled blinded animal trial, 24 pigs are divided into a long- or short-gap EA group (LGEA and SGEA, respectively) and randomized to... (More)
Background:
Esophageal atresia (EA) is a congenital malformation affecting 1:3000-4500 newborns. Approximately 15% have a long-gap EA (LGEA), in which case a primary anastomosis is often impossible to achieve. To create continuity of the esophagus patients instead have to undergo lengthening procedures or organ interpositions; methods associated with high morbidity and poor functional outcomes. Esophageal injections of Botulinum Toxin Type A (BTX-A) could enable primary anastomosis and mitigate stricture formation through decreased tissue tension.

Methods and Analysis:
In this randomized controlled blinded animal trial, 24 pigs are divided into a long- or short-gap EA group (LGEA and SGEA, respectively) and randomized to receive BTX-A or isotonic saline injections. In the LGEA group, injections are given endoscopically in the esophageal musculature. After seven days, a 3 cm esophageal resection and primary anastomosis is performed. In the SGEA group, a 1 cm esophageal resection and primary anastomosis is performed, followed by intraoperative injections of BTX-A or isotonic saline. After 14 days, stricture formation, presence of leakage, and esophageal compliance is assessed using endoscopic and manometric techniques, and in vivo and ex vivo contrast radiography. Tissue elongation is evaluated in a stretch-tension test, and the esophagus is assessed histologically to evaluate anastomotic healing.

Ethics and Dissemination:
The study complies with the ARRIVE guidelines for animal studies and has been approved by the Danish Animal Experimentation Council. Results will be published in peer-reviewed journals and presented at national and international conferences. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
International Journal of Surgery Protocols
volume
25
issue
1
pages
171 - 177
publisher
Elsevier
external identifiers
  • pmid:34435166
ISSN
2468-3574
DOI
10.29337/ijsp.156
language
English
LU publication?
yes
id
2ef90b28-31e8-4568-b870-522b1194713e
date added to LUP
2021-11-24 22:45:53
date last changed
2021-11-26 03:00:04
@article{2ef90b28-31e8-4568-b870-522b1194713e,
  abstract     = {{Background:<br/>Esophageal atresia (EA) is a congenital malformation affecting 1:3000-4500 newborns. Approximately 15% have a long-gap EA (LGEA), in which case a primary anastomosis is often impossible to achieve. To create continuity of the esophagus patients instead have to undergo lengthening procedures or organ interpositions; methods associated with high morbidity and poor functional outcomes. Esophageal injections of Botulinum Toxin Type A (BTX-A) could enable primary anastomosis and mitigate stricture formation through decreased tissue tension.<br/><br/>Methods and Analysis:<br/>In this randomized controlled blinded animal trial, 24 pigs are divided into a long- or short-gap EA group (LGEA and SGEA, respectively) and randomized to receive BTX-A or isotonic saline injections. In the LGEA group, injections are given endoscopically in the esophageal musculature. After seven days, a 3 cm esophageal resection and primary anastomosis is performed. In the SGEA group, a 1 cm esophageal resection and primary anastomosis is performed, followed by intraoperative injections of BTX-A or isotonic saline. After 14 days, stricture formation, presence of leakage, and esophageal compliance is assessed using endoscopic and manometric techniques, and in vivo and ex vivo contrast radiography. Tissue elongation is evaluated in a stretch-tension test, and the esophagus is assessed histologically to evaluate anastomotic healing.<br/><br/>Ethics and Dissemination:<br/>The study complies with the ARRIVE guidelines for animal studies and has been approved by the Danish Animal Experimentation Council. Results will be published in peer-reviewed journals and presented at national and international conferences.}},
  author       = {{Svensson, Emma and Zvara, Peter and Qvist, Niels and Hagander, Lars and Möller, Sören and Rasmussen, Lars and Daa Schrøder, Henrik and Kildall Hejböl, Eva and Björn, Niels and Petersen, Susanna and Cederström Larsen, Kristine and Krhut, Jan and Muensterer, Oliver J and Bremholm Ellebaek, Mark}},
  issn         = {{2468-3574}},
  language     = {{eng}},
  month        = {{08}},
  number       = {{1}},
  pages        = {{171--177}},
  publisher    = {{Elsevier}},
  series       = {{International Journal of Surgery Protocols}},
  title        = {{The Effect of Botulinum Toxin Type A Injections on Stricture Formation, Leakage Rates, Esophageal Elongation, and Anastomotic Healing Following Primary Anastomosis in a Long- and Short-Gap Esophageal Atresia Model : A Protocol for a Randomized, Controlled, Blinded Trial in Pigs}},
  url          = {{http://dx.doi.org/10.29337/ijsp.156}},
  doi          = {{10.29337/ijsp.156}},
  volume       = {{25}},
  year         = {{2021}},
}