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.