Totally Endoscopic Gastric Plication Using A Novel Endoscopic Stapler

Santiago Horgan, Alejandro Grigaites, Pablo Omelanczuk, Veronica Gorodner, Rudolf Buxhoeveden, Rodrigo Ongay

UCSD, Hospital Aleman de Buenos Aires, Hospital Italiano de Mendoza. Programa Unidades Bariatricas

Objective: to date, bariatric surgery has proven to be the most effective treatment for obesity. Even though Roux -en- Y gastric bypass is considered the gold standard, investigation is focused on the development of less invasive techniques for the treatment of this disease. We describe our experience in Argentina performing a totally endoscopic gastric plication (TEGP) with the ACE (articulating circular endoscopic) stapler, without laparoscopic approach. Our objective is to present initial results during this trial, using the ACE stapler.

Description of the technology and methods: prospective multicenter trial.

Selection criteria: patients with BMI 30-40 with comorbidities or ≥ 40 kg/m², with no previous history of bariatric surgery. The procedure was performed under general anesthesia, using the ACE stapler. By creating TEGPs, the volume and expansion of the fundus and greater curvature of the stomach were decreased to create an earlier sensation of fullness. The procedure was completed fully endoscopically, without laparoscopic assistance. The procedure began with the introduction of an overtube (OT) to protect the esophagus. The ACE stapler was then introduced under endoscopic view, and the instrument’s head was positioned towards the gastric mucosa. Vacuum was utilized to create full thickness serosa to serosa tissue apposition. The stapler then compressed tissue and deployed staples, creating a TEGP. From 7 to 10 TEGPs were placed in each patient. The primary objective was to demonstrate safety of the device, by evaluating the incidence of adverse events, while the secondary objective was to determine effectiveness by assessing weight loss and improvements in, or resolution of, comorbidities.

Preliminary results: between April and September 2012, 22 patients were selected; 1 was excluded because of an esophageal abnormality that prevented introduction of the OT. Therefore, 21 patients underwent TEGP. Of them, 17 patients have had ≥ 1 month follow up to date. Mean age was 39, and initial BMI 36.9 kg/m². Mean operative time was 72 min, and patients were discharged home on postoperative day 1-2. Adverse events have all been transient and mild to moderate in severity, and of the type commonly seen for an endoscopic procedure under general anesthesia. No Serious Adverse Events occurred during the study. Weight loss was as follows:
Follow up # patients Mean % EWL Mean % Total Weight loss (kg)
7 days 2113.84.9
1 month 17 21.07.5
2 months 15 24.69.2
3 months 10 28.411.2

Conclusion: this initial experience demonstrates that TEGP for the treatment of obesity is feasible and safe. Short term results are encouraging. Long term follow up will prove its effectiveness.

Session: Podium Presentation

Program Number: ET004

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