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.