Esophagus to Small Intestine
Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): A prospective, multicenter, randomized trial
Background: Endoscopic sleeve gastroplasty (ESG) is an endoluminal, organ-sparing therapy for obesity, with wide global adoption. The authors aimed to explore the efficacy and safety of ESG with lifestyle modifications compared with lifestyle modifications alone.
Methods: They conducted a randomized clinical trial at 9 US centers, 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 end point 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. Secondary end points included change in metabolic comorbidities between the groups. Multiple imputed intention-to-treat (ITT) analyses with mixed-effects models were used. The analyses were done on a per-protocol (PP) basis and a modified ITT basis. The safety population was defined as all participants who underwent ESG (both primary and crossover ESG) up to 52 weeks.
Findings: Between December 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 end point of mean percentage of EWL was 49.2 ± 32.0% for the ESG group and 3.2 ± 18.6% for the control group (p < 0.0001). Mean percentage of total body weight loss was 13.6 ± 8.0% for the ESG group and 0.8 ± 5.0% for the control group (p < 0.0001), and 59 of 77 participants (77%) in the ESG group reached ≥ 25% of EWL at 52 weeks compared with 13 of 110 (12%) in the control group (p < 0.0001). At 52 weeks, 41 of 51 participants (80%) in the ESG group had an improvement in ≥ 1 metabolic comorbidities, whereas 6 (12%) worsened, compared with the control group in which 28 of 62 participants (45%) had similar improvement, whereas 31 (50%) worsened. At 104 weeks, 41 of 60 participants (68%) in the ESG group maintained ≥ 25% of EWL. ESG-related serious adverse events occurred in 3 of 131 participants (2%), without mortality or need for intensive care or surgery.
Interpretation: Endoscopic sleeve gastroplasty (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.