First human results of a novel endoscopic gastric plication device in the treatment of obesity

G F Paulus, MD, T Verlaan, MD, E M Mathus-Vliegen, MD, PhD, E A Veldhuyzen, J M Conchillo, MD, PhD, P Fockens, N D Bouvy, MD, PhD. Maastricht University Medical Center, Academic Medical Center Amsterdam.

Background

Endoscopic volume reduction of the stomach may provide a minimal-invasive alternative for surgical procedures in the treatment of obesity and provide an option for patients currently not eligible for bariatric surgery.

Methods

Safety and primary effectiveness of the Articulating Circular Endoscopic™ (ACE™) stapler for gastric volume reduction in the treatment of obesity were evaluated. This prospective observational phase 1 study was conducted in two academic hospitals in the Netherlands. Patients with a BMI of 40-45 kg/m2 or 30-39.9 kg/m2 with obesity related comorbidity, aged 18-50 were invited to participate.

Primary outcome measure to assess safety was the prevalence of (serious) adverse events. Reduction of excess body weight was assessed for effectiveness of the procedure and was a secondary outcome measure at 3, 6, 9 and 12 months.

Results

Seventeen patients (6 male, median age 37 years, IQR 32-48) with a median BMI of 40.2 kg/m2 (IQR 37.6-42.8) were included and underwent an ACE stapling procedure. Comorbidities included hypercholesterolemia (n=4), hypertension (n=4), type II Diabetes (n=2) and obstructive sleep apnea syndrome (n=2). In all patients nine or ten plications could be made and median procedure time was 123 (IQR 95-129) minutes. No serious adverse events occurred. Adverse events were gastric pain (n=7, range 1-3 days), sore throat (n=4, 2-3 days), diarrhea (n=4, 2-15 days), nausea (n=3, 2-4 days), constipation (n=4, 3-14 days), and vomiting (n=3, 1-4 days). All adverse events were mild and resolved with conservative treatment within 15 days after surgery. The median percentage excess weight loss in the first year was 34.9% (IQR 17.8-46.6)

Conclusions

This first human application of the ACE stapler demonstrates that the procedure is technically feasible and safe. One hundred and sixty plications were created in 17 patients without significant problems. Preliminary weight-loss results are promising, but long-term follow-up as well as randomized controlled studies should evaluate whether this procedure is an effective and durable minimally invasive endoscopic treatment for obesity.