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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. 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. 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. 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. Apollo Endosurgery, Mayo Clinic.

IntroductionDurability is a key requirement for the broad acceptance of bariatric surgery. We report on durability at and beyond 10 years with a systematic review and meta-analysis of all reports providing data at 10 or more years and a single-centre study of laparoscopic adjustable gastric banding (LAGB) with 20 years of follow-up.MethodsSystematic review with meta-analysis was performed on all eligble reports containing 10 or more years of follow-up data on weight loss after bariatric surgery. In addition, a prospective cohort study of LAGB patients measuring weight loss and reoperation at up to 20 years is presented.ResultsSystematic review identified 57 datasets of which 33 were eligible for meta-analysis. Weighted means of the percentage of excess weight loss (%EWL) were calculated for all papers included in the systematic review. Eighteen reports of gastric bypass showed a weighted mean of 56.7%EWL, 17 reports of LAGB showed 45.9%EWL, 9 reports of biliopancreatic bypass +/− duodenal switch showed 74.1%EWL and 2 reports of sleeve gastrectomy showed 58.3%EWL. Meta-analyses of eligible studies demonstrated comparable results. Reoperations were common in all groups. At a single centre, 8378 LAGB patients were followed for up to 20 years with an overall follow-up rate of 54%. No surgical deaths occurred. Weight loss at 20 years (N = 35) was 30.1 kg, 48.9%EWL and 22.2% total weight loss (%TWL). Reoperation rate was initially high but reduced markedly with improved band and surgical and aftercare techniques.ConclusionAll current procedures are associated with substantial and durable weight loss. More long-term data are needed for one-anastomosis gastric bypass and sleeve gastrectomy. Reoperation is likely to remain common across all procedures.

Background Endoscopic sleeve gastroplasty (ESG) is a technique for managing mild to moderately obese patients. We aimed to evaluate the long-term outcomes, reproducibility, and predictors of weight response in a large multicenter cohort. Methods Patients who underwent ESG between January 2013 and December 2015 in three centers were retrospectively analyzed. All procedures were performed using the Apollo OverStitch device (Apollo Endosurgery, Austin, TX). We performed per protocol (PP) and intention-to-treat (ITT) analyses, where patients lost to follow-up were considered failures. Multivariable linear and logistic regression analyses were performed. Results We included 248 patients (mean age 44.5 ± 10 years, 73% female). Baseline BMI was 37.8 ± 5.6 kg/m 2 . At 6 and 24 months, 33 and 35 patients were lost to follow-up, respectively. At 6 and 24 months, %TBWL was 15.2 [95%CI 14.2–16.3] and 18.6 [15.7–21.5], respectively. Weight loss was similar between centers at both follow-up intervals. At 24 months, % of patients achieving ≥10% TBWL was 84.2 and 53% with PP and ITT analyses, respectively. On multivariable linear regression analysis, only %TBWL at 6 months strongly predicted %TBWL at 24 months (adjusted for age, gender, and baseline BMI, β  = 1.21, p  < 0.001). The odds of achieving ≥10%TBWL at 24 months if a patient achieved <10%TBWL at 6 months is 0.18 [0.034–0.84]. Five (2%) serious adverse events occurred. Conclusions ESG effectively induces weight loss up to 24 months in moderately obese patients. Failure to achieve adequate weight loss can be predicted early, and patients should be offered adjunctive therapies to augment it.

Background Obesity is a significant global health issue. Metabolic and bariatric surgery (MBS) is the gold standard in the treatment of obesity due to its proven effectiveness and safety in the short and long term. However, MBS is not suitable for all patients. Some individuals are at high surgical risk or refuse surgical treatment, while others do not meet the criteria for MBS despite having obesity-related comorbidities. This gap has driven the development of endoscopic solutions like endoscopic sleeve gastroplasty (ESG), which offers a less invasive alternative that preserves organ function and reduces risks. A recent IFSO International Delphi consensus study highlighted that multidisciplinary experts agree on the utility of ESG for managing obesity in patients with class I and II obesity and for those with class III obesity who do not wish to pursue or qualify for MBS. This IFSO Bariatric Endoscopy Committee position statement aims to augment these consensus statements by providing a comprehensive systematic review of the evidence and delivering an evidence-based position on the value of ESG within the spectrum of obesity management. Methods A comprehensive systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) and Cochrane guidelines. Results Systematic Review: The systematic review included 44 articles encompassing 15,714 patients receiving ESG. The studies varied from large case series to cohort studies and a randomized controlled trial (RCT). The mean baseline BMI was 37.56 kg/m2. The review focused on weight loss outcomes and safety data. Meta-analysis: Time point Mean %EWL Mean %TBWL 6 months 48.04 15.66 12 months 53.09 17.56 18 months 57.98 16.25 24 months 46.57 15.2 36 months 53.18 14.07 60 months 45.3 15.9 These results demonstrate significant weight loss following ESG. Safety: The pooled serious adverse event (SAE) rate was 1.25%. This low rate of SAEs indicates that ESG is a relatively safe procedure. Quality of Evidence: The quality of evidence from the included observational studies was assessed as very low, primarily due to the inherent limitations associated with observational study designs, such as potential biases and lack of randomization. In contrast, the quality of evidence from the single randomized controlled trial was rated as MODERATE, reflecting a more robust study design that provides a higher level of evidence despite some limitations. Conclusions The IFSO Bariatric Endoscopy Committee, after conducting a comprehensive systematic review and meta-analysis, endorses endoscopic sleeve gastroplasty (ESG) as an effective and valuable treatment for obesity. ESG is particularly beneficial for patients with class I and II obesity, as well as for those with class III obesity who are not suitable candidates for metabolic bariatric surgery. ESG provides significant weight loss outcomes and demonstrates a favorable safety profile with a low rate of serious adverse events. Despite the limitations of the included observational studies, the randomized controlled trial included in the analysis reinforces the efficacy and safety of ESG and provides an evidence-based foundation for the position statement. Thus, the IFSO position statement supports and provides an evidence base for the role of ESG within the broader spectrum of obesity management.

Laparoscopic vertical clip gastroplasty (LVCG) with BariClip is a recent procedure that appears to be safe Gentileschi et al. (Obes Surg 33(1):303-12, 2023 ). The initial complications reported include erosion, slippage, and gastroesophageal reflux. This study aimed to report on the experience of a single surgical group, analyzing three clinical cases, conducting a literature review, and proposing a standardization of the technique. A retrospective study was conducted with data from June 2021 to October 2024. We collected the data from the procedures related to the bariatric clip made by only one surgical group; we collected 69 cases with 1 complication of this surgical group. Additionally, we described 2 clinical cases of complications related to bariatric clips from other surgical institutions and reviewed the literature related to the BariClip experience. The results are related to the evaluation of the technique and compare the different modifications implemented over the last 3 years of follow-up. Furthermore, we aim to share our experience in attending to one of the most concerning complications associated with this procedure. The LVCG is a safe procedure with a low incidence of complications and positive results in %EWL. We propose several modifications to the original technique to further reduce complications, and we share the experience of both treating and resolving some of the complications we encountered.

Background Endoscopic sleeve gastroplasty (ESG) is a novel endobariatric procedure. Initial studies demonstrated an association of ESG with weight loss and improvement of obesity-related comorbidities. Our aim was to compare ESG to laparoscopic sleeve gastrectomy (LSG) and laparoscopic adjustable gastric banding (LAGB). Methods We included 278 obese (BMI > 30) patients who underwent ESG ( n  = 91), LSG ( n  = 120), or LAGB ( n  = 67) at our tertiary care academic center. Primary outcome was percent total body weight loss (%TBWL) at 3, 6, 9, and 12 months. Secondary outcome measures included adverse events (AE), length of stay (LOS), and readmission rate. Results At 12-month follow-up, LSG achieved the greatest %TBWL compared to LAGB and ESG (29.28 vs 13.30 vs 17.57%, respectively; p  < 0.001). However, ESG had a significantly lower rate of morbidity when compared to LSG or LAGB ( p  = 0.01). The LOS was significantly less for ESG compared to LSG or LAGB (0.34 ± 0.73 vs 3.09 ± 1.47 vs 1.66 ± 3.07 days, respectively; p  < 0.01). Readmission rates were not significantly different between the groups ( p  = 0.72). Conclusion Although LSG is the most effective option for weight loss, ESG is a safe and feasible endobariatric option associated with low morbidity and short LOS in select patients.

Background and AimsNovel endoscopic procedures (endoscopic sleeve gastroplasty (ESG), AspireAssist (AA), and primary obesity surgery endolumenal (POSE)) have been developed for treatment of obesity. We aimed to conduct a systematic review and meta-analysis to evaluate and compare the efficacy of these three endoscopic procedures.MethodsMain outcomes of interest were percent excess weight loss (%EWL) and percent total body weight loss (%TBWL). Weighted pooled means (WPMs) were calculated and analyzed using random effects model. Mean differences (MDs) were calculated to compare these procedures.ResultsTwelve studies with 1149 patients were included. WPMs for %EWL at 6 and 12 months with ESG were 49.67 (45.67, 53.66) and 52.75 (43.52, 61.98), respectively, while %TBWLs at 6 and 12 months with ESG were 16.01 (15.10, 16.92) and 17.41 (17.08, 17.74), respectively. WPMs for %EWL at 6 and 12 months with POSE were 43.79 (40.17, 47.42) and 44.91 (40.90, 48.92), respectively. WPM for %EWL at 12 months with AA was 50.85 (46.03, 55.68). While comparing ESG and POSE, at 6 months and 12 months, MD for %EWL was 6.17 (1.07, 11.26; P = 0.01) and 7.84 (− 2.05, 17.71; P = 0.06) in favor of ESG. No difference in %EWL was observed while comparing ESG with AA (P = 0.29). Likewise, MD for %EWL to compare AA and POSE was not significant (P = 0.68).ConclusionsDuring a follow-up of 6–12 months, both AA and ESG had excellent efficacy in achieving significant and sustained weight loss; however, ESG was found to be superior in terms of weight loss when compared with POSE.

Background A short-term randomized controlled trial shows that the one anastomosis gastric bypass (OAGB) is a safe and effective alternative to the Roux-en-Y gastric bypass (RYGB). Objective The aim of this study is to evaluate the OAGB at our University Hospital between 2006 and 2013. Patients One thousand patients have undergone an OAGB. Data were collected on all consecutive patients. The mean follow-up period was 31 months (SD, 26.3; range, 12–82.9), and complete follow-up was available in 126 of 175 patients (72 %) at 5 years after surgery. Results Mortality rate was 0.2 %. Overall morbidity was 5.5 %; 34 required reoperations: i.e., 6 leaks, 5 obstructions, 5 incisional hernias, 7 biliary refluxes, 2 perforated ulcers, 2 bleeds, 2 abscesses, and 1 anastomotic stricture. Four patients were reoperated for weight regain. Overall rate of marginal ulcers was 2 % ( n  = 20), all in heavy smokers. Conversion from an OAGB to a RYGB was required in nine cases (0.9 %): seven for intractable biliary reflux, two for a marginal ulcer. At 5 years, percent excess body mass index loss was 71.6 ± 27 %. One hundred patients with type-2 diabetes, with a mean preoperative HbA1C of 7.7 ± 1.9 %, were followed for >2 years; the total resolution rate was 85.7 %. Conclusion This study confirms that the OAGB is an effective procedure for morbid obesity with comparable outcomes to RYGB; in addition, it seems to be safer with lower morbidity. Its technical simplicity represents a real advantage and makes it an option that should be considered by all bariatric surgeons.

BackgroundPrimary obesity surgery endoluminal (POSE) utilizes an incision-less operating platform system to create full-thickness plications in the gastric fundus and body (original POSE). Many studies have demonstrated the safety and efficacy of original POSE for the treatment of obesity.ObjectiveWe aimed to conduct a systematic review and meta-analysis of available literature in an attempt to evaluate the outcomes of original POSE per the ASGE task force thresholds.MethodsBibliographic databases were systematically searched for studies assessing the outcomes of POSE for the treatment of obesity. All randomized controlled trials (RCTs) and observational studies that assessed outcomes of POSE were included. Studies were included if they reported percent total weight loss (%TWL) or percent excess weight loss (%EWL) and the incidence of serious adverse events (SAE).ResultsA total of seven studies with 613 patients were included. Two included studies were RCTs, while the remaining were observational studies. Pooled mean %EWL at 3–6 months and 12–15 months were 42.62 (95% CI 37.56–47.68) and 48.86 (95% CI 42.31–55.41), respectively. Pooled mean %TWL at 3–6 months and 12–15 months was 13.45 (95% CI 8.93–17.97) and 12.68 (95% CI 8.13–17.23), respectively. Subgroup analysis of two RCTs showed that weight loss at 1 year was significantly higher in POSE patients (%EWL difference in means 19.45 (95% CI 4.65–34.24, p value = 0.01). The overall incidence of serious adverse events was only 2.84% and included GI bleeding, extra-gastric bleeding, hepatic abscess, severe pain, severe nausea, and severe vomiting. The mean number of total anchors placed in the fundus and body was 13.18 (95% CI 11.77–14.58), and the mean procedure time was 44.55 min (95% CI 36.44–52.65).ConclusionPOSE, a minimally invasive endoscopic bariatric therapy, is a safe and effective modality for the treatment of obesity. The outcomes of POSE meet and surpass the ASGE joint task force thresholds. Future studies should evaluate newer versions of this procedure that emphasize gastric body plication sparing the fundus.

Non-alcoholic fatty liver disease (NAFLD) is the most common cause of liver disease worldwide. Endoscopic sleeve gastroplasty (ESG) has proven to be feasible, safe, and effective in the management of obesity. We performed the first systematic review and meta-analysis evaluating NAFLD and other metabolic parameters 12 months post-ESG. Four observational studies with a total of 175 patients were included. The results showed a significant (p < 0.05) reduction of 4.85 in hepatic steatosis index (95% CI − 6.02, − 3.67), 0.5 in NAFLD fibrosis score (95% CI − 0.80, − 0.19), 6.32 U/l in ALT (95% CI − 9.52, − 3.11), 17.28% in TWL (95% CI − 18.24, − 16.31), 6.31 kg/m2 in BMI (95% CI − 8.11, − 4.52), 47.97% in EWL (95% CI − 49.10, − 46.84), and 0.51% in HbA1c (95% CI − 0.90, − 0.12). ESG improves liver parameters, provides weight loss, and reduces HbA1c levels in patients suffering from NAFLD.