Background: Secure access and reliable closure is paramount in the setting of transesophageal mediastinal endoscopic surgery. The purpose of this study was to develop a secure transesophageal access technique and to evaluate the feasibility, safety, and efficacy of a novel covered, self-expanding, retractable stent for closure of 15-mm esophageal defects.
Methods: Fifteen-millimeter esophagotomies were created in 18 domestic pigs using needle knife puncture and balloon dilatation or a blunt dissection technique. Six animals were randomly assigned to open surgical repair and six animals to endoscopic closure using a self-expanding, covered, nitinol stent (Danis SX-ELLA stent, ELLA-CS) in a nonsurvival setting. Pressurized leak tests were performed on all closures. Six animals underwent transesophageal endoscopic mediastinal interventions and survived for 17 days. Stents were extracted at day 10.
Results: Nonsurvival experiments revealed two bleeding complications associated with the needle-knife access technique, while blunt-dissection mediastinal access was not associated with any complications. Leak test results were not different for stent compared to surgical closures. All survival animals were found to have complete closure and adequate healing of the esophagotomies. No leakage or infectious complication occurred.
Conclusion: Blunt dissection achieves safe access into the mediastinum. Stent closure achieves similar leak test results compared to surgical closure and results in adequate sealing and wound healing of 15-mm esophageal defects.