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

BackgroundWe 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.ObjectiveCreation of a NOTES gastroduodenal anastomosis in patients.DesignCase series.SettingTwo tertiary-care referral centers at large academic hospitals in France and in the United States.PatientsPatients with refractory benign duodenal stenosis and malignant duodenal obstruction.InterventionNOTES GI anastomosis with a lumen-apposing stent.Main Outcome MeasurementsDisappearence of gastric outlet obstruction.ResultsAll 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.LimitationsSmall case series.ConclusionNOTES gastroenteric anastomosis is feasible and safe in humans. A prospective pilot study is warranted.