Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial.

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.

Learning Process Effectiveness During the COVID-19 Pandemic: Teleproctoring Advanced Endoscopic Skills by Training Endoscopists in Endoscopic Sleeve Gastroplasty Procedure.

BACKGROUND AND AIMS: The COVID-19 pandemic has led health institutions to cancel many of the activities including training in different fields. Most practices and training programs have been encouraged to use teleproctoring as an alternative method to enhance physician's ability and assure training. We aimed to evaluate remote training program for endoscopy sleeve gastroplasty (ESG). METHODS: Ten consecutive patients underwent an endoscopic sleeve gastroplasty procedure guided by a proctor expert using an online platform. A stepwise approach was created to assure skill acquisition. RESULTS: All cases were safely performed with no serious adverse events under teleproctoring. The average surgical and suturing times significantly decreased during the training model. From the first 5 cases to the last 5 ones, the endoscopic procedure time decreased from 120 to 93.4 min while suturing time from 92.8 to 68.4 min. The effect size was large in both cases, and the changes were meaningful according to the fitted learning curves. CONCLUSIONS: The proposed teleproctoring program was effective to deliver advanced endoscopic skills such as endosuturing for ESG, despite the restrictions imposed by the COVID-19 pandemic.

Id: 3526666 Tubular Pouchplasty Transoral Outlet Reduction (Ttore) Is Superior to and More Durable Than Traditional Tore in a Large Cohort Study

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

IFSO Endoscopy Committee Position Statement on the Practice of Bariatric Endoscopy During the COVID-19 Pandemic.

COVID-19 (Coronavirus disease 2019) caused by SARS-CoV-2 has become a global pandemic. Obesity is a risk factor for severe disease, and the practice of endoscopy poses special challenges and risks of SARS-CoV-2 transmission to patients and providers given the evolving role of the gastrointestinal tract in viral transmission and aerosol generation during endoscopic procedures. It is therefore necessary to distinguish between urgent interventions that cannot be postponed despite the risks during the pandemic and, in contrast, purely elective interventions that could be deferred in order to minimize transmission risks during a time of infection surge and limited access. Semi-urgent bariatric procedures have an intermediate position. Since the chronological course of the pandemic is still unpredictable, these interventions were defined according to whether or not they should be performed within a nominal 8-week period. In this position statement, the IFSO Endoscopy Committee offers guidance on navigating bariatric endoscopic procedures in patients with obesity during the COVID-19 pandemic, in the hope of mitigating the risk of SARS-CoV-2 transmission to vulnerable patients and healthcare workers. These recommendations may evolve as the pandemic progresses.