S718 Clinical Outcome at 18 Month Follow-Up of 3 Endoscopic Gastroplasty Techniques: A Single Center, Randomized Controlled Trial

Introduction: Endoscopic gastroplasty (EG) is an endoscopic therapy to treat obese patients focusing on gastric body remodeling. We considered 3 different techniques: endoscopic sleeve gastroplasty (ESG), endoluminal vertical gastroplasty (EVG), and distal primary obesity surgery endoluminal (POSE2). Methods: This was a single center, randomized controlled trial (ClinicalTrials.gov NCT04854317) of obese patients who underwent EG (through ESG or EVG or POSE2) or a low-calorie Mediterranean diet (1,600 and 1,400 Kcal/day). Outcomes included technical success rate, serious adverse event rate, and efficacy of the 3 EG procedures at inducing weight loss, improving obesity related comorbidities and quality of life (QoL), compared to diet. Results: From July 2020 to May 2022, 240 obese (body mass index 37.5 ± 3.5 kg/m) patients (mean age 46 ± 10 years; women 87.8%; obesity class II 58.3%; hepatic steatosis as the main comorbidity in 70%) underwent EG (60 patients for each procedure, 180 patients in total) or a low-calorie diet (60 patients). In the EG group the technical success rate was 100%. The serious adverse event rate was 1.1%. The follow-up visit was attended by 100/180 (55.6%), 48/180 (26.7%) and 19/180 (10.6%) patients at 6, 12 and 18 months, respectively. They experienced 16.1%, 13.7% and 14.1% total body weight loss (TBWL) and 39.7%, 35.3% and 34.7% excess weight loss (EWL) at 6, 12 and 18 months, respectively, with no significant difference among the 3 techniques in both parameters (P > 0.62 in %TBWL and P > 0.94 in EWL% ANOVA tests) at 18 months follow-up. Concerning the low-calorie diet group, 31/60 (52%), 13/60 (22%) and 4/60 (6%) patients attended their 6-, 12-, and 18-month follow-up; they experienced 1.1% TBWL (P < 0.001 versus EG group) and 2.3% EWL (P < 0.001 versus EG group) at 18 months. Ninety seven of 100 (97.0%), 37/48 (77.1%) and 16/19 (84.2%) patients achieved at least 5% TBWL, while 86/100 (86.0%), 32/48 (66.6%) and 15/19 (78.9%) achieved at least 25% EWL in the EG group at 6, 12 and 18 months follow-up, compared to 4/31 (12.9%), 1/13 (7.6%) and 0/4 (0%), and 3/31 (9.7%), 1/13 (7.6%) and 0/4 (0%) in the diet group, at 6, 12 and 18 months. Most comorbidities and the QoL, measured by EQ-5D, improved after the EG procedure at 18 months, while no improvement was observed in the diet group. Conclusion: EG through ESG, EVG and D-POSE are technically feasible and safe, and appear to be effective for the treatment of obese patients, compared to diet, at a medium term follow-up.