Project description:Obesity and its complications, such as type 2 diabetes, hypertension, hyperlipidemia, nonalcoholic fatty liver, are serious global public health problems. Endoscopic sleeve gastroplasty (ESG) can reduce the length and width of the stomach by simulating the anatomical structure of surgical sleeve gastrectomy to reduce the capacity of the stomach, and is safe and effective to reduce weight. ESG has the advantages of non- invasiveness, no gastrectomy, repeatability, simple operation, no incision scar, few complications, short hospital stay and quick postoperative recovery. As an intermediate means of medical treatment and surgery, ESG provides a new method for weight loss for obese patients who cannot tolerate or are unwilling to undergo surgery. Herein we trace the origin of ESG, analyze the unique advantages of ESG suture, explore the technical improvement in the development of ESG, and briefly describe the weight reduction effect of ESG and compare the curative effect of ESG with laparoscopic sleeve gastrectomy. ESG has undergone rapid development and maturity but also faces such challenges as the lack of established standard procedures, unclear weight reduction mechanism, and clarification of the indications for operation. Still, ESG is expected to become the mainstream technique for weight reduction.
Project description:ImportanceObesity is a disease with a large socioeconomic burden. Endoscopic sleeve gastroplasty (ESG) is a minimally invasive endoscopic bariatric procedure with wide global adoption. More recently, new weight-loss medications, such as glucagon-like peptide-1 receptor agonists (eg, semaglutide), have attracted increased attention due to their efficacy. However, their cost-effectiveness over an extended period compared with ESG is a critical gap that needs to be better explored for informed health care decision-making.ObjectiveTo assess the cost-effectiveness of semaglutide compared with ESG over 5 years for individuals with class II obesity.Design, setting, and participantsThis economic evaluation study, conducted from September 1, 2022, to May 31, 2023, used a Markov cohort model to compare ESG and semaglutide, with a no-treatment baseline strategy. The study comprised adult patients in the US health care system with class II obesity (body mass index [BMI] of 35-39.9). The base case was a 45-year-old patient with class II obesity (BMI of 37). Patients undergoing ESG were subjected to risks of perioperative mortality and adverse events with resultant costs and decrement in quality of life.InterventionsStrategies included treatment with semaglutide and ESG.Main outcomes and measuresCosts (2022 US dollars), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) with a willingness-to-pay threshold of $100 000/QALY. A 5-year time horizon with a cycle length of 1 month with a 3% discount rate was used. Probabilities, costs, and quality-of-life estimates of the model were derived from published literature. One-way, 2-way, and probabilistic sensitivity analyses were also performed.ResultsThe model found that ESG was more cost-effective than semaglutide over a 5-year time horizon, with an ICER of -$595 532/QALY. Endoscopic sleeve gastroplasty added 0.06 QALYs and reduced total cost by $33 583 relative to semaglutide. The results remained robust on 1-way and probabilistic sensitivity analyses. Endoscopic sleeve gastroplasty sustained greater weight loss over 5 years vs semaglutide (BMI of 31.7 vs 33.0). To achieve nondominance, the annual price of semaglutide, currently $13 618, would need to be $3591.Conclusions and relevanceThis study suggests that ESG is cost saving compared with semaglutide in the treatment of class II obesity. On price threshold analyses, a 3-fold decrease in the price of semaglutide is needed to achieve nondominance.
Project description:Background and study aims This was a single-blind, single-center, prospective randomized controlled trial aimed at comparing the efficacy of three different suture patterns for endoscopic sleeve gastroplasty using Endomina (E-ESG). Patients and methods The suture patterns aimed to modify gastric accommodation by increasing the fundus distention ability (Group A), to reduce gastric volume (Group B) or to interrupt gastric emptying (Group C). Patients were randomized 1:1:1 and underwent clinical follow-up, gastric emptying scintigraphy, and satiety tests at baseline and 6 and 12 months post-procedure. The primary outcome was total body weight loss (TBWL) and excess weight loss (EWL) at 12 months post-procedure. Secondary outcomes included the impact of the suture patterns on gastric emptying and satiety. Results Overall, 48 patients (40 [83.3 %] female, aged 41.9 ± 9.5 years, body mass indexI 33.8 ± 2.7 kg/m 2 ) were randomized (16 in each group). In the entire cohort, mean (95 % confidence interval [CI]) TBWL and EWL at the end of the follow-up were 10.11 % (7.1-13.12) and 42.56 (28.23-56.9), respectively. There was no difference among the three study groups in terms of TBWL (95 %CI) (9.13 % [2.16-16.11] vs. 11.29 % [5.79-16.80] vs. 9.96 % [4.58-15.35]; P = 0.589) and EWL (95 %CI) (34.54 % [6.09-62.99] vs. 44.75 % [23.63-65.88] vs. 46.94 % [16.72-77.15]; P = 0.888) at 12 months post-procedure. The three groups did not differ in terms of mean gastric emptying time or in terms of satiety tests at the end of the follow-up. No serious adverse events occurred. Conclusions Three different suture patterns during E-ESG demonstrated comparable efficacy in terms of weight loss, with an overall EWL of > 25 % and TBWL of > 10 % at 12 months.
Project description:Weight non-response after sleeve gastrectomy is an emerging issue. This systematic review compared revisional procedures for weight-related outcomes. We searched several databases for relevant articles and included adult patients with revisional bariatric procedures after primary sleeve gastrectomy. Twelve trials with 1046 patients were included, covering five revisional procedures. There were no randomised controlled trials, and 10 studies had a critical risk of bias. Significant variations in inclusion criteria, therapy benchmarks, follow-up schemes, and outcome measurements were observed, preventing meaningful comparison of results. Evidence-based treatment strategies for weight non-response after sleeve gastrectomy cannot be deduced from the current literature. Prospective studies with well-defined indications, standardised techniques, and strict adherence to outcome measurements are needed.
Project description:BackgroundBariatric endoscopic techniques are minimally invasive and induce gastric volume reduction to treat obesity. Aim : To evaluate endoscopic sleeve gastroplasty (Apollo method) using a suturing method directed at the greater curvature, as well as the perioperative care, two year safety and weight loss.MethodProspective single-center study over 154 patients (108 females) using the endoscopic sleeve gastroplasty procedure under general anesthesia with overnight inpatient observation. Of the154 initial patients, 143 were available for 1-month of follow-up, 133 for 6-month, 64 for 12-month and 28 completed the 24 month assessment. Follow-up was carried out by a multidisciplinary team (nutritionist and psychologist). Outcomes evaluated were: change in BMI; change in body weight (TBWL); % of loss of initial body weight (%TBWL); % of excess body weight loss (%EWL) (segregated in > or <25% and adverse effects. Voluntary oral contrasted radiological examinations were scheduled to assess the gastroplasty at different times post-procedure.ResultsMean age was 44.9 (23-69) years. At 24 months after the procedure baseline mean BMI change from 38.3 to 30.8 kg/m2. TBWL, %TBWL and %EWL were of 21.3 kg, 19.5% and 60.4% respectively. 85.7% of patients achieve the goal of >25% %EWL. There were no mayor adverse events intraprocedure or during the 24 months of follow-up .ConclusionEndoscopic sleeve gastroplasty with regular monitoring by a multidisciplinary team can be considered an effective, safe and well tolerated procedure for obesity treatment, at least for two years of follow-up.
Project description:Background and study aimsBariatric endoscopy has emerged as an aid in the nonsurgical treatment of obesity. The objective of this study is to critically provide the results and follow-up of endoscopic sleeve gastroplasty 1 year after the procedure.Patients and methodsProspective single-center follow-up study of 25 patients (5 men, 20 women) who underwent flexible endoscopic suturing for endoluminal gastric volume reduction. A multidisciplinary team provided post-procedure care. Patient outcomes were recorded at 1 year after the procedure. Linear regression analysis was done to evaluate the variables associated with best results at 1 year of follow-up.ResultsMean body mass index (BMI) was 38.5 ± 4.6 kg/m(2) (range 30 - 47) and mean age 44.5 ± 8.2 years (range 29 - 60). At 1 year, 22 patients continued with the follow-up (2 dropped out at 6 months and 1 at 3 months). There were no major intra-procedural, early, or delayed adverse events. Mean BMI loss was 7.3 ± 4.2 kg/m(2), and mean percentage of total body weight loss was 18.7 ± 10.7 at 1 year. In the linear regression analysis, adjusted by initial BMI, variables associated with %TBWL involved the frequency of nutritional (β = 0.563, P = 0.014) and psychological contacts (β = 0.727, P = 0.025). The number of nutritional and psychological contacts were predictive of good weight loss results.ConclusionsEndoscopic sleeve gastroplasty is a feasible, reproducible, and effective procedure to treat obesity. Nutritional and psychological interaction are predictive of success.
Project description:Background and study aims Endoscopic sleeve gastroplasty (ESG) is performed in clinical practice by gastroenterologists and bariatric surgeons. Given the increasing regulatory approval and global adoption, we aimed to evaluate real-world outcomes in multidisciplinary practices involving bariatric surgeons and gastroenterologists across the United States. Patients and methods We included adult patients with obesity who underwent ESG from January 2013 to August 2022 in seven academic and private centers in the United States. Patient and procedure characteristics, serious adverse events (SAEs), and weight loss outcomes up to 24 months were analyzed. SPSS (version 29.0) was used for all statistical analyses. Results A total of 1506 patients from seven sites included 235 (15.6%) treated by surgeons and 1271 (84.4%) treated by gastroenterologists. There were no baseline differences between groups. Gastroenterologists used argon plasma coagulation for marking significantly more often than surgeons ( P <0.001). Surgeons placed sutures in the fundus in all instances whereas gastroenterologist placed them in the fundus in less than 1% of the cases ( P <0.001>). Procedure times were significantly different between groups, with surgeons requiring approximately 20 minutes more during the procedure than gastroenterologists ( P <0.001). Percent total body weight loss (%TBWL) and percent responders achieving >10 and >15% TBWL were similar between the two groups at 12, 18, and 24 months. Rates of SAEs were low and similar at 1.7% for surgeons and 2.7% for gastroenterologists ( P >0.05). Conclusions Data from a large US cohort show significant and sustained weight loss with ESG and an excellent safety profile in both bariatric surgery and gastroenterology practices, supporting the scalability of the procedure across practices in a multidisciplinary setting.