Transoral mucosal excision sutured gastroplasty: a pilot study for GERD and obesity with two-year follow-up.

Introduction: An outpatient transoral endoscopic procedure for gastroesophageal reflux disease (GERD) and obesity would be appealing if safe, effective, and durable. We present the first in human experience with a new system.

Methods: Eight patients with GERD (3) and obesity (5) were selected according to a preapproved study protocol. All GERD patients had preprocedure manometry and pH monitoring to document GERD as well as quality of life and symptom questionnaires. Obese patients (body mass index >35) underwent a psychological evaluation and tests for comorbidities. Under general anesthesia, a procedure was performed at the gastroesophageal junction including mucosal excision, suturing of the excision beds for apposition, and suture knotting.

Results: One patient with micrognathia could not undergo the required preprocedural passage of a 60 F dilator and was excluded. The first 2 GERD patients had incomplete procedures due to instrument malfunction. The subsequent 5 subjects had a successfully completed procedure. Four patients were treated for obesity and had an average excess weight loss of 30.3% at 2-year follow-up. Of these patients, one had an 8-mm outlet at the end of the procedure recognized on video review--a correctable error--and another vomited multiple times postoperatively and loosened the gastroplasty sutures. The treated GERD patient had resolution of reflux-related symptoms and is off all antisecretory medications at 2-year follow-up. Her DeMeester score was 8.9 at 24 months.

Conclusion: The initial human clinical experience showed promising results for effective and safe GERD and obesity therapy.