Background: The largest barrier limiting the integration of natural orifice translumenal endoscopic surgery (NOTES) into routine practice is obtaining safe endoscopic closure of the transvisceral access point. The endolumenal ability to close gastric defects may spare patients morbidity associated with traditional surgery; however, no device for gastric closure has proven efficacy. The aim of this study was to determine the feasibility of closing a gastric NOTES incision with the NDO Plicator, a unique endoscopic device designed to create full-thickness gastric plications with non-absorbable pledgeted sutures.
Methods: Six 40 kg female swine were anesthetized and underwent endoscopic creation of a standardized 12 mm circular transgastric NOTES defect. Defects were closed with the NDO Plicator and evaluated with upper-gastrointestinal contrast fluoroscopy (CF) to confirm adequate closure. CF was repeated on post-operative days #2 and #7. Animals were sacrificed 14 days following surgery, and underwent laparotomy to assess closure-site complications. Closure sites were evaluated for integrity. Ex vivo burst testing was performed with compressed oxygen.
Results: Leak-free closure took a mean of 47 minutes, and required a median of three Plicator applications per animal. CF failed to demonstrate post-operative leakage in any animal at any time point. All animals thrived and gained weight without identifiable clinical complications. No inadvertent injuries to surrounding organs or abscesses were noted. There were flimsy omental adhesions to the closure site in all animals. Ex vivo burst pressure testing revealed the closure site was stronger than native tissue in 50% (n = 3) of animals. For the remainder of the animals, the surgical site failed at an average pressure of 82 mm Hg.
Conclusions: The NDO Plicator provides a completely endoscopic method of safe, full-thickness, leak-proof closure of standardized gastric defects in the chronic porcine model. Tissue strength at the closure site mimics tissue strength remote to the gastric defect. These results support the development of human trials testing the Plicator’s ability to close uncontrolled gastric defects such as gastric fistulas, gastroenteric anastomotic leaks, and NOTES access sites.