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.