ABSTRACT
BACKGROUND: 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: 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. FUNDING: Apollo Endosurgery, Mayo Clinic.
Subject(s)
Gastroplasty , Gastroplasty/adverse effects , Gastroplasty/methods , Humans , Obesity/etiology , Obesity/surgery , Prospective Studies , Treatment Outcome , Weight LossABSTRACT
The proceedings contains 638 papers. The topics discussed include: 3526666 TUBULAR POUCHPLASTY TRANSORAL OUTLET REDUCTION (TTORE) IS SUPERIOR TO AND MORE DURABLE THAN TRADITIONAL TORE IN A LARGE COHORT STUDY;3522113 ENDOSCOPIC VERSUS SURGICAL GASTROJEJUNAL REVISION FOR WEIGHT REGAIN IN ROUX-EN-Y GASTRIC BYPASS PATIENTS: 5-YEAR SAFETY AND EFFICACY COMPARISON;3526904 PRIMARY OBESITY SURGERY ENDOLUMINAL 2 (POSE 2.0): AN INTERNATIONAL MULTICENTER PROSPECTIVE TRIAL WITH PLICATION DURABILITY ASSESSMENT;3523069 CHANGES IN INCRETINS, BILE ACIDS AND THE MICROBIOME AFTER DUODENAL MUCOSAL RESURFACING IN PATIENTS WITH TYPE 2 DIABETES;3523981 THE “ERAS” PROTOCOL REDUCES POST ENDOSCOPIC BARIATRIC PROCEDURE HEALTHCARE UTILIZATION;3520884 QUANTIFYING HEALTHCARE UTILIZATION AND DELAY IN TREATMENT OF GASTRIC STENOSIS FOLLOWING SLEEVE GASTRECTOMY;3523424 ENODOSCOPIC SLEEVE GASTROPLASTY (ESG) SUCCESSES AND FAILURES: PREDICTORS FOR ESG REVISION;3525620 ENDOSCOPIC SLEEVE GASTROPLASTY AS NEW HOPE FOR MILD OBESITY;3526737 HOW WELL MY PATIENT WILL DO? PERSONALITY TRAITS PREDICT WEIGHT LOSS AFTER ENDOSCOPIC SLEEVE GASTROPLASTY;3492486 SEMAGLUTIDE IN ASSOCIATION TO ENDOSCOPIC SLEEVE GASTROPLASTY: TAKING ENDOSCOPIC BATRIATRIC PROCEDURES OUTCOMES TO THE NEXT LEVEL;3520710 GLYCEMIC AND HEPATIC OUTCOMES AFTER ENDOSCOPIC DUODENAL MUCOSAL RESURFACING: A SYSTEMATIC REVIEW AND META-ANALYSIS;3525747 SHORT TERM OUTCOMES OF ENDOSCOPIC SLEEVE GASTROPLASTY (ESG) IN TYPE III OBESE PATIENTS: A CLINICAL, RETROSPECTIVE, SINGLE CENTER STUDY;3526510 ENDOSCOPIC SEPTOTOMY/STAPLE LINE RELEASE TO TREAT AN UNUSUAL CAUSE OF DYSPHAGIA AFTER SLEEVE GASTRECTOMY;3526579 MODIFIED ENDOSCOPIC SUBMUCOSAL DISSECTION – TRANSORAL OUTLET REDUCTION (ESD-TORE) FOR WEIGHT REGAIN;3522594 SAFETY AND FEASIBILITY OF SAME DAY DISCHARGE AFTER PER ORAL ENDOSCOPIC PYLOROMYOTOMY IN REFRACTORY GASTROPARESIS: A PILOT STUDY;3524289 IMPACT OF COVID-19 ON THE MANAGEMENT AND OUTCOMES OF SEVERE ACUTE CHOLANGITIS: FINDINGS FROM A NATIONWIDE CLINICAL DATA RESEARCH NETWORK