Charam Khosrovani. Clinique Fontvert
Introduction: Anastomotic leak is one of the most serious complications of esophageal surgery with a 30% post-operative death, reduced quality of life and negative outcome in cancer patients. Until now there is no efficient therapy to reduce the risks of esophageal anastomotic adverse events. Covered stents are routinely and successfully used in the curative management of esophageal anastomotic leak but they are prone to migration. The use of covered stents to prevent the risks of anastomotic adverse events seems rational as long as the risk of migration is mitigated.
Esovac is the first anastomotic bypass device protecting an esogastric anastomosis. It consists of a removable covered stent attached to a nasogastric tube (NGT) by means of a loop suture to eliminate stent migration thus the need of a strong radial force is alleviated. The device is set within a floppy tube to maintain the stent closed. Removable LEDs are set in the lumen of NGT to enlighten the stent and to facilitate its location through the anastomosis. The aim of this study was to evaluate the safety of Esovac implanting-explanting manoeuvres and the risk of stent migration in pig models.
Methods: Five animals were allocated to receive Esovac. The cardia was resected through a midline laparotomy and a manual esogastric anastomosis was created. Esovac was inserted through the nostril in the esophagus and the stent was located in the anastomosis thanks to LEDs transesophageal illumination. The external tube was manually pulled out then the stent was deployed. The NGT was fixed to internasal septum. Animals fed a liquid diet during the postoperative course.
Results: All Esovac deliveries and deployments were technically successful with no adverse event nor difficulty observed during the initial surgery. One animal died because of pulmonary infection not related to the device. Esovac was explanted successfully at postoperative day 7. No adverse event was observed during the stent removal. No significant resistance nor bleeding were observed during upper airways passage.
Conclusions: Esovac implanting-explanting manoeuvres are safe. The risk of stent migration is eliminated by Esovac in a porcine esogatsric anastomosis model. A risk mitigation of esophageal anastomosis leak by Esovac is anticipated. A safety clinical study is scheduled in 2018.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 91185
Program Number: ET008
Presentation Session: Emerging Technology Session (Non CME)
Presentation Type: Podium