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

Emma Svensson, Peter Zvara, Niels Qvist, Lars Hagander, Sören Möller, Lars Rasmussen, Henrik Daa Schrøder, Eva Kildall Hejbøl, Niels Bjørn Jørgen, Súsanna Petersen, Kristine Cederstrøm Larsen, Jan Krhut, Oliver J. Muensterer, Mark Bremholm Ellebæk

Research output: Contribution to journalJournal articleResearchpeer-review

6 Downloads (Pure)

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 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.

Highlights:

The optimal management of long-gap esophageal atresia remains controversial
Primary anastomosis could improve functional outcomes and reduce complications
Botulinum Toxin Type A decreases tissue tension and could facilitate anastomosis
Reduced tension could further abate the risk for anastomotic stricture and leakage
We present a model to evaluate the method in long- and short-gap esophageal atresia
Original languageEnglish
JournalInternational Journal of Surgery Protocols
Volume25
Issue number1
Pages (from-to)171–177
DOIs
Publication statusPublished - 11. Aug 2021

Fingerprint

Dive into the research topics of 'The Effect of Botulinum Toxin Type A Injections on Stricture Formation, Leakage Rates, Esophageal Elongation, and Anastomotic Healing Following Primary Anastomosis in a Longand Short-Gap Esophageal Atresia Model: A Protocol for a Randomized, Controlled, Blinded Trial in Pigs'. Together they form a unique fingerprint.

Cite this