Position statement

ASGE position statement on endoscopic bariatric therapies in clinical practice

Endoscopic sleeve gastroplasty (ESG) is an endolumenal, organ-sparing therapy for obesity, with wide global adoption. We aimed to explore the efficacy and safety of ESG with lifestyle modifications compared with lifestyle modifications alone.

We conducted a randomised clinical trial at nine US centres, enrolling individuals aged 21–65 years with class 1 or class 2 obesity and who agreed to comply with lifelong dietary restrictions. Participants were randomly assigned (1:1·5; with stratified permuted blocks) to ESG with lifestyle modifications (ESG group) or lifestyle modifications alone (control group), with potential retightening or crossover to ESG, respectively, at 52 weeks. Lifestyle modifications included a low-calorie diet and physical activity. Participants in the primary ESG group were followed up for 104 weeks. The primary endpoint at 52 weeks was the percentage of excess weight loss (EWL), with excess weight being that over the ideal weight for a BMI of 25 kg/m². Secondary endpoints included change in metabolic comorbidities between the groups. We used multiple imputed intention-to-treat analyses with mixed-effects models. Our analyses were done on a per-protocol basis and a modified intention-to-treat basis. The safety population was defined as all participants who underwent ESG (both primary and crossover ESG) up to 52 weeks.

Between Dec 20, 2017, and June 14, 2019, 209 participants were randomly assigned to ESG (n=85) or to control (n=124). At 52 weeks, the primary endpoint of mean percentage of EWL was 49·2% (SD 32·0) for the ESG group and 3·2% (18·6) for the control group (p<0·0001). Mean percentage of total bodyweight loss was 13·6% (8·0) for the ESG group and 0·8% (5·0) for the control group (p<0·0001), and 59 (77%) of 77 participants in the ESG group reached 25% or more of EWL at 52 weeks compared with 13 (12%) of 110 in the control group (p<0·0001). At 52 weeks, 41 (80%) of 51 participants in the ESG group had an improvement in one or more metabolic comorbidities, whereas six (12%) worsened, compared with the control group in which 28 (45%) of 62 participants had similar improvement, whereas 31 (50%) worsened. At 104 weeks, 41 (68%) of 60 participants in the ESG group maintained 25% or more of EWL. ESG-related serious adverse events occurred in three (2%) of 131 participants, without mortality or need for intensive care or surgery.

ESG is a safe intervention that resulted in significant weight loss, maintained at 104 weeks, with important improvements in metabolic comorbidities. ESG should be considered as a synergistic weight loss intervention for patients with class 1 or class 2 obesity. This trial is registered with ClinicalTrials.gov, NCT03406975.

Apollo Endosurgery, Mayo Clinic.

The growing burden of obesity as a chronic disease necessitates a multifaceted approach to management. There has been an increase in the number of available endoscopic therapies for weight management with endoscopic sleeve gastroplasty (ESG) proving to be one of the best options. The long-term efficacy of ESG for management of obesity is not known. This study sought to assess the long-term safety and efficacy of ESG for treatment of obesity.

This was a prospective cohort study. Participants underwent ESG in a single academic center, and were prospectively enrolled. All procedures were performed by the same therapeutic endoscopist. Patients with a body mass index of >30 kg/m2 (or >27 with comorbidities), who underwent ESG from August 2013 to August 2019 for treatment of obesity were enrolled. Patients were followed for up to 5 years after their procedure. The primary outcome was weight loss at 5 years after the procedure (% total body weight loss, TBWL)

216 patients (68% female) with a mean age of 46±13 years, and mean BMI of 39±6 kg/m² underwent ESG. Out of 216 patients, 203, 96, and 68 patients were eligible for a 1-, 3-, and 5-year follow up, with complete follow-up rates of 70%, 71%, and 82%, respectively. At 5 years, mean TBWL was 15.9% (95% CI, 11.7-20.5, p < .001) and 90 and 61% of patients maintained 5 and 10% TBWL, respectively. There was an overall rate of 1.3% moderate adverse events (AEs), without any severe or fatal AEs.

Our results suggest that ESG is safe and effective for treatment of obesity, with durable long-term results for at least up to 5 years after the procedure. This procedure should be considered as a reliable option for treatment of obesity.