The Use of Botulinum Toxin Type A in Esophageal Atresia Management: a Randomized, Controlled, Investigator-blinded Feasibility and Exploratory Trial in Piglets

Anastomotic strictures and leaks are severe complications following esophageal atresia (EA) repair. We hypothesized that esophageal injections of botulinum toxin type A (BTX-A) could mitigate these complications through muscle relaxation. This randomized, controlled, blinded animal trial evaluated the feasibility and safety of a long- and short-gap porcine EA model. Furthermore, the effect of BTX-A as a surgical adjunct on anastomotic outcomes were exploratory assessed. Twenty-four animals received BTX-A or saline pre- or intraoperative to a three- or one-centimeter esophageal resection and primary anastomosis. The primary feasibility endpoint was animal completion rate at postoperative day 14, while stricture severity was the primary exploratory outcome. Secondary exploratory outcomes were anastomotic leakage frequency, and biomechanical and histological characteristics. Animal completion rate was 62.5% (15/24). There was no difference in stricture severity between the intervention and control groups (Esophageal Anastomotic Stricture Index 0.41 [IQR 0.26-0.55] versus 0.35 [IQR 0.27-0.58]; p = 0.73). One animal in the control group suffered an anastomotic leak. Biomechanical properties and anastomotic healing did not differ. While the procedure was technically feasible, refinement is necessary to reduce attrition rate and establish a safe model for long-term evaluation. More studies are needed to determine whether BTX-A can provide a reduction in anastomotic complications.