Endoscopic gastric reduction with an endoluminal suturing device: a multicenter prospective trial with 1-year follow-up

Endoscopy. 2018 Dec;50(12):1156-1162. doi: 10.1055/a-0630-1224. Epub 2018 Jun 15.

Abstract

Background: Obesity is the pandemic disease of this century. Surgery is the only effective treatment but cannot be offered to every patient. Endoscopic sutured gastroplasty is a minimally invasive technique that may potentially fill the gap between surgery and behavioral therapy. In this study, we prospectively investigated the efficacy and safety of a novel suturing device.

Methods: After a pre-bariatric multidisciplinary work-up, class 1 and 2 obese patients were included. Using a simple triangulation platform, transmural sutures with serosa-to-serosa apposition were performed in the gastric cavity. Patients were followed according to the same routines as those performed for bariatric procedures.

Results: Between November 2015 and December 2016, 51 patients were included across three European Centers. Mean body mass index at baseline was 35.1 kg/m2 (SD 3.0). Excess weight loss and total body weight loss at 1 year were 29 % (SD 28) and 7.4 % (SD 7), respectively, for the whole cohort (45 patients). At follow-up gastroscopy, 88 % of sutures were still in place (30 patients). No severe adverse events were observed.

Conclusions: Endoscopic sutured gastroplasty using this novel device is safe and achieved weight loss results in line with criteria expected for these endoluminal techniques. Further prospective studies vs. placebo or nutritional support are needed.

Trial registration: ClinicalTrials.gov NCT02582229.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Video-Audio Media

MeSH terms

  • Adult
  • Body Mass Index
  • Female
  • Follow-Up Studies
  • Gastroplasty / adverse effects
  • Gastroplasty / instrumentation*
  • Gastroscopy
  • Humans
  • Male
  • Middle Aged
  • Obesity / surgery*
  • Prospective Studies
  • Suture Techniques / adverse effects
  • Suture Techniques / instrumentation*
  • Weight Loss

Associated data

  • ClinicalTrials.gov/NCT02582229