Natural orifice transluminal endoscopic surgery gastrotomy closure in porcine explants with the Padlock-G clip using the Lock-It system

Abstract

The success of transgastric surgery depends on reliable, secure closure of the gastrotomy. Few tests of the integrity of these closures have been published. This study aimed to determine whether a gastrotomy suitable for a NOTES procedure can be closed safely and effectively from within the stomach using a novel endoscopically placed device, the Padlock-G with the Lock-It delivery system. In a series of eight consecutive porcine gastric explants gastrotomy was performed in an ex vivo animal laboratory, the gastrotomy being closed with the Padlock-G followed by burst pressure testing after completion of the procedure. Gastrotomies were made in porcine explants. T-tags were placed on either side of the gastrotomy, and, with the T-tags pulled into an endoscopic cap, the Padlock-G was deployed. Gastric transmural pressure gradients at bursting of these closures were measured during insufflation of the explanted stomachs with a high-pressure insufflator. The mean burst pressure of the gastrotomy closures was 68.0 mm Hg (range: 45 - 107 mm Hg). All of the stomachs ultimately ruptured at the closure sites, with the exception of the stomach that ruptured at the highest value (107 mm Hg), which ruptured at a site approximately 5 cm away from the closure site. All of the closures were accomplished in 30 minutes or less. The Padlock-G clip provides a secure gastric closure for natural-orifice surgery.