Natural orifice transluminal endoscopic surgery gastroenterostomy with a biflanged lumen-apposing stent: first clinical experience (with videos)

Background We established feasibility and safety for natural orifice transluminal endoscopic surgery (NOTES) GI anastomosis with a lumen-apposing stent in live pigs. This approach was performed in 3 patients. Objective Creation of a NOTES gastroduodenal anastomosis in patients. Design Case series. Setting Two tertiary-care referral centers at large academic hospitals in France and in the United States. Patients Patients with refractory benign duodenal stenosis and malignant duodenal obstruction. Intervention NOTES GI anastomosis with a lumen-apposing stent. Main Outcome Measurements Disappearence of gastric outlet obstruction. Results All 3 procedures were technically successful and uneventful, except 1 minor adverse event. There were no instances of stent occlusion or migration during follow-up. All patients resumed a normal diet. Limitations Small case series. Conclusion NOTES gastroenteric anastomosis is feasible and safe in humans. A prospective pilot study is warranted.