Machine learning models to predict success of endoscopic sleeve gastroplasty using total and excess weight loss percent achievement: a multicentre study.

BACKGROUND: The large amount of heterogeneous data collected in surgical/endoscopic practice calls for data-driven approaches as machine learning (ML) models. The aim of this study was to develop ML models to predict endoscopic sleeve gastroplasty (ESG) efficacy at 12 months defined by total weight loss (TWL) % and excess weight loss (EWL) % achievement. Multicentre data were used to enhance generalizability: evaluate consistency among different center of ESG practice and assess reproducibility of the models and possible clinical application. Models were designed to be dynamic and integrate follow-up clinical data into more accurate predictions, possibly assisting management and decision-making. METHODS: ML models were developed using data of 404 ESG procedures performed at 12 centers across Europe. Collected data included clinical and demographic variables at the time of ESG and at follow-up. Multicentre/external and single center/internal and temporal validation were performed. Training and evaluation of the models were performed on Python's scikit-learn library. Performance of models was quantified as receiver operator curve (ROC-AUC), sensitivity, specificity, and calibration plots. RESULTS: Multicenter external validation: ML models using preoperative data show poor performance. Best performances were reached by linear regression (LR) and support vector machine models for TWL% and EWL%, respectively, (ROC-AUC: TWL% 0.87, EWL% 0.86) with the addition of 6-month follow-up data. Single-center internal validation: Preoperative data only ML models show suboptimal performance. Early, i.e., 3-month follow-up data addition lead to ROC-AUC of 0.79 (random forest classifiers model) and 0.81 (LR models) for TWL% and EWL% achievement prediction, respectively. Single-center temporal validation shows similar results. CONCLUSIONS: Although preoperative data only may not be sufficient for accurate postoperative predictions, the ability of ML models to adapt and evolve with the patients changes could assist in providing an effective and personalized postoperative care. ML models predictive capacity improvement with follow-up data is encouraging and may become a valuable support in patient management and decision-making.

Prospective evaluation of transoral outlet reduction (TORe) after Roux-en-Y gastric bypass (RYGB) failure.

BACKGROUND AND AIMS: Weight regain after RYGB is multifactorial including dilatation of the gastro-jejunal anastomosis. Transoral outlet reduction (TORe) procedure is a minimally invasive alternative to surgical anastomotic revision. METHODS: We conducted a prospective, multicenter, simple blind, randomized study in patients with weight regain following RYGB, comparing the efficacy of conventional nutritional and behavioral management associated with a TORe procedure (TORe group) with conventional management alone and a Sham procedure (Sham group). The main objective of this study was to evaluate the percentage of excess weight loss (%EWL) at 12 months after endoscopy. RESULTS: From January 2015 to January 2019, 73 subjects were randomized in four French Bariatric centers. The final analysis involved 50 subjects, 25 in each group, 44 women, 6 men, with an average BMI of 40.6 kg/m2. At 12 months, the average %EWL was significantly higher in the TORe group than in the Sham group (13.5 ± 14.1 vs. - 0.77 ± 17.1; p = 0.002). Cohen's d was 0.91, indicating a large effect size of the procedure on the %EWL. There was no significant difference between groups concerning the improvement of obesity-related comorbidities (diabetes and dyslipidemia) and quality of life at 12 months. We report frequent adverse events in the TORe group (20% had adverse events related to the procedure). Three adverse events were serious, including two perforations of the gastro-jejunal anastomosis after TORe group that led to the premature termination of the study. CONCLUSIONS: After RYGBP failure linked to the dilatation of the gastro-jejunal anastomosis, TORe procedure with nutritional management results in significantly higher %EWL at 12 months compared to patients with nutritional management alone. As surgery, this minimally invasive endoscopic procedure can be associated with severe adverse events.

Gastro-esophageal diagnostic workup before bariatric surgery or endoscopic treatment for obesity: position statement of the International Society of Diseases of the Esophagus.

Obesity is a chronic and multifactorial condition characterized by abnormal weight gain due to excessive adipose tissue accumulation that represents a growing worldwide challenge for public health. In addition, obese patients have an increased risk of hiatal hernia, esophageal, and gastric dysfunction, as well as gastroesophageal reflux disease, which has a prevalence over 40% in those seeking endoscopic or surgical intervention. Surgery has been demonstrated to be the most effective treatment for severe obesity in terms of long-term weight loss, comorbidities, and quality of life improvements and overall mortality decrease. The recent emergence of bariatric endoscopic techniques promises less invasive, more cost-effective, and reproducible approaches to the treatment of obesity. With the endorsement of the International Society for Diseases of the Esophagus, we started a Delphi process to develop consensus statements on the most appropriate diagnostic workup to preoperatively assess gastroesophageal function before bariatric surgical or endoscopic interventions. The Consensus Working Group comprised 11 international experts from five countries. The group consisted of gastroenterologists and surgeons with a large expertise with regard to gastroesophageal reflux disease, bariatric surgery and endoscopy, and physiology. Ten statements were selected, on the basis of the agreement level and clinical relevance, which represent an evidence and experience-based consensus of the International Society for Diseases of the Esophagus.

Updates in metabolic bariatric endoscopy.

Obesity and its associated comorbid conditions have been increasing globally. Endoscopic bariatric and metabolic therapies (EBMTs) were initially designed to replicate bariatric surgery physiology for those who are not or choose not to be surgical candidates. Now, newer procedures target the complicated pathophysiology underlying obesity and its comorbidities. EBMT has been categorized based on its therapeutic target (stomach or small intestine), but innovations have expanded to include extraintestinal organs including the pancreas. Gastric EBMTs, namely space-occupying balloons, gastroplasty with suturing or plication, and aspiration therapy, are primarily used for weight loss. Small bowel EBMTs are designed to cause malabsorption, epithelial endocrine remodeling, and other changes to intestinal physiology to ultimately improve the metabolic comorbidities of obesity rather than induce weight loss alone. These include duodenal mucosal resurfacing, endoluminal bypass sleeves, and incisionless anastomosis systems. Extraluminal or pancreatic EBMT is aimed to restore the production of normal pancreatic proteins that are involved in the progression of type 2 diabetes. This review discusses the current and new technologies of metabolic bariatric endoscopy, their pros and cons, and areas for future research.

Prospective Multicenter Study of the Primary Obesity Surgery Endoluminal (POSE 2.0) Procedure for Treatment of Obesity.

BACKGROUND & AIMS: The Primary Obesity Surgery Endoluminal (POSE) 2.0 procedure involves a novel pattern of full-thickness gastric body plications to shorten and narrow the stomach using durable suture anchor pairs. Our prospective, multicenter trial examined the safety, efficacy, durability, and physiologic effects of POSE 2.0 in adults with obesity. METHODS: Adults with obesity underwent POSE 2.0 at 3 centers. Primary outcomes were percent total body weight loss (%TBWL) and proportion of patients achieving >5% TBWL at 12 months. Secondary outcomes included change in obesity comorbidities, satiety, quality of life at 6 months, and durability of plications at 12 and 24 months. Subjects were followed for adverse events throughout the study duration. RESULTS: 44 patients (61% female; mean age, 45 ± 9.7 years; mean body mass index, 37 ± 2.1 kg/m2) were enrolled. This procedure used an average of 19 suture anchor pairs, with a mean duration of 37 ± 11 minutes, and was technically successful in all subjects. Mean %TBWL at 12 months was 15.7% ± 6.8%. At 12 months, %TBWL >5%, >10%, and >15% was achieved in 98%, 86%, and 58% of patients, respectively. Improvements in lipid profile, liver biochemistries, and hepatic steatosis were seen at 6 months. Improvements in hepatic steatosis persisted for 24 months in a subgroup of patients (P < .01). POSE 2.0 reduced maximum tolerated meal volume (P = .03) and was associated with increased fullness (P < .01) and improved eating behavior (P < .01) at 6 months. Impact of weight on quality-of-life questionnaire improved at 6 months (2.23 vs 1.23; P < .01). Repeat assessment at 24 months (n = 26) showed fully intact plications. No serious adverse events occurred. CONCLUSION: POSE 2.0 is an effective and durable endoscopic bariatric therapy which may influence physiologic pathways impacting satiety. Larger comparative studies are needed to further elucidate these initial findings. CLINICALTRIALS: gov Identifier: NCT03721731.

A pilot study of implementation of endoscopic sleeve gastroplasty (ESG) in Norway.

BACKGROUND AND AIM: Bariatric surgery is the most effective treatment for obesity but is invasive and associated with serious complications. Endoscopic sleeve gastroplasty (ESG) is a less invasive weight loss procedure to reduce the stomach volume by full-thickness sutures. ESG has been adopted in many countries, but implementation at Scandinavian centres has not yet been documented. We performed a clinical pilot trial at a Norwegian centre with the primary objective to assess the feasibility of the ESG procedure. PATIENTS AND METHODS: We included the first 10 patients treated with ESG at a Norwegian centre in a single-arm pilot study. The eligibility criteria were either a body mass index (BMI) of 40-49.9 kg/m2, BMI 35-39.9 kg/m2 and at least one obesity-related comorbidity, or BMI 30-34.9 kg/m2 and type 2 diabetes. Patient follow-up resembled the scheme used for bariatric surgery at the center, including dietary plans and outpatient visits. RESULTS: All procedures were technically successful except for one patient who had adhesions between the stomach and anterior abdominal wall, related to a prior hernia repair, resulting in less-than-intended stomach volume reduction. Mean total body weight loss (TBWL) after 26 and 52 weeks was 12.2% (95% CI 8.1-16.2) and 9.1% (95% CI 3.3 - 15.0). One patient experienced a minor suture-induced diaphragmatic injury, which was successfully managed conservatively. CONCLUSIONS: This first Scandinavian clinical trial of ESG, documenting the implementation of the procedure at a Norwegian center, demonstrated acceptable feasibility and safety, with large variations in individual weight loss during the 52-week follow-up period.

Endoscopic Sleeve Gastroplasty Assisted by Postgraduate Medical Trainees: An Early Safety Analysis.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an emerging bariatric intervention with comparable safety and efficacy to surgical sleeve gastrectomy (SG). As ESG is utilized more commonly, postgraduate medical training in bariatric endoscopy has expanded to train physicians in this technically complex procedure. Prior studies have analyzed procedural outcomes of bariatric surgery assisted by medical trainees, but no such analysis has been performed with ESG. AIMS: This study aims to evaluate the short-term safety of ESG in cases assisted by postgraduate medical trainees. METHODS: We retrospectively analyzed over 2000 patients in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database from 2016 to 2020. Cases of ESG performed with the assistance of postgraduate medical trainees (residents and/or fellows) were propensity matched (1:1) to cases of ESG performed without trainee involvement. We compared the occurrences of adverse events (AE), readmissions, re-interventions, and re-operations between these matched cohorts of ESG. Secondary outcomes included procedure time, length of stay (LOS), and total body weight loss (TBWL). RESULTS: A total of 1204 cases of ESG assisted by postgraduate medical trainees were compared to 1204 matched cases without trainee involvement. Procedures performed by attending physicians alone had fewer AE (0.7% vs 2.0%, p = 0.014) and rates of re-operations (0.8% vs 2.4%, p = 0.004) compared to procedures assisted by trainees. There were no significant differences in readmissions (4.0% vs 4.4%, p = 0.684) or reinterventions (3.8% vs. 4.6%, p = 0.416) at 30 days. Cases involving trainees had longer duration (71 vs 51 min, p < 0.001) and LOS (1.11 vs. 0.5 days, p < 0.001). TBWL at 30 days was greater in procedures performed with trainees (4.1% vs 3.4%, p = 0.033). CONCLUSION: ESG is a technically complex procedure that can be safely performed with trainee assistance. Academic medical centers may continue supporting the expansion of training in bariatric endoscopy as an advanced endoscopic skill.

Endoscopic therapies for patients with obesity: a systematic review and meta-analysis.

BACKGROUND: Obesity is a major threat to public health and traditional bariatric surgery continues to have low utilization. Endoscopic treatments for obesity have emerged that offer less risk, but questions remain regarding efficacy, durability, and safety. We compared the efficacy of endoscopic bariatric procedures as compared to other existing treatments. METHODS: A literature search of Embase, Cochrane Central, and Pubmed was conducted from January 1, 2014 to December 7, 2021, including endoscopic bariatric therapies that were FDA or CE approved at the time of search to non-endoscopic treatments. Thirty-seven studies involving 15,639 patients were included. Primary outcomes included % total body weight loss (%TBWL), % excess body weight loss (%EBWL), and adverse events. Secondary outcomes included quality of life data and differences in hemoglobin A1C levels. Strength of clinical trial and observational data were graded according to the Cochrane methods. RESULTS: Intragastric balloons achieved greater %TBWL with a range of 7.6-14.1% compared to 3.3-6.7% with lifestyle modification at 6 months, and 7.5-14.0% compared to 3.1-7.9%, respectively, at 12 months. When endoscopic sleeve gastroplasty (ESG) was compared to laparoscopic sleeve gastrectomy (LSG), ESG had less %TBWL at 4.7-14.4% compared to 18.8-26.5% after LSG at 6 months, and 4.5-18.6% as compared to 28.4-29.3%, respectively, at 12 months. For the AspireAssist, there was greater %TBWL with aspiration therapy compared to lifestyle modification at 12 months, 12.1-18.3% TBWL versus 3.5-5.9% TBWL, respectively. All endoscopic interventions had higher adverse events rates compared to lifestyle modification. CONCLUSION: This review is the first to evaluate various endoscopic bariatric therapies using only RCTs and observational studies for evaluation of weight loss compared with conservative management, lifestyle modification, and bariatric surgery. Endoscopic therapies result in greater weight loss compared to lifestyle modification, but not as much as bariatric surgery. Endoscopic therapies may be beneficial as an alternative to bariatric surgery.

Transoral gastric outlet reduction for post-prandial hypoglycemia after Roux-en-Y gastric bypass.

BACKGROUND: Post-prandial hypoglycemia is an uncommon but disabling late complication of Roux-en-Y gastric bypass (RYGB). Most patients can be treated with dietary interventions and medications; however, some patients develop refractory hypoglycemia that may lead to multiple daily episodes and seizures. While RYGB reversal surgery is an effective treatment, complication rates are high, and patients inevitably experience weight regain. Transoral gastric outlet reduction (TORe) is a minimally invasive treatment that is effective for early and late dumping syndrome. However, prior studies have not distinguished the effectiveness of TORe specifically for patients with post-prandial hypoglycemia. This study aims to describe a single institution's experience of TORe for treating post-prandial hypoglycemia. METHODS: This is a case series of patients with prior RYGB complicated by post-prandial hypoglycemia who underwent TORe from February 2020 to September 2021. Pre-procedural characteristics and post-procedural outcomes were obtained. Outcomes assessed included post-prandial hypoglycemia episodes, dumping syndrome symptoms, and weight change. RESULTS: A total of 11 patients underwent TORe from 2020 to 2021 for post-prandial hypoglycemia. Three (27%) patients had a history of seizures due to hypoglycemia. All had been advised on dietary changes, and ten patients (91%) were on medications for dumping. All patients reported a reduction in post-prandial hypoglycemic events as well as the majority of dumping syndrome symptoms during an average follow-up time of 409 ± 125 days. Ten patients (91%) had experienced weight regain from their post-RYGB nadir weight. For these patients, the average total body weight loss 12 months post-TORe was 12.4 ± 12%. There were no complications requiring hospitalization. One patient experienced post-TORe nausea and vomiting requiring dilation of the gastrojejunal anastomosis with resolution in symptoms. CONCLUSION: TORe is a safe and effective treatment for post-prandial hypoglycemia and weight regain after RYGB in patients with symptoms refractory to medications and dietary changes.

Transoral Outlet Reduction (TORe) for the Treatment of Weight Regain and Dumping Syndrome after Roux-en-Y Gastric Bypass.

Obesity is a chronic relapsing disease of global pandemic proportions. In this context, an increasing number of patients are undergoing bariatric surgery, which is considered the most effective weight loss treatment for long-term improvement in obesity-related comorbidities. One of the most popular bariatric surgeries is the Roux-en-Y gastric bypass (RYGB). Despite its proven short- and long-term efficacy, progressive weight regain and dumping symptoms remain a challenge. Revisional bariatric surgery is indicated when dietary and lifestyle modification, pharmaceutical agents and/or psychological therapy fail to arrest weight regain or control dumping. However, these re-interventions present greater technical difficulty and are accompanied by an increased risk of peri- and postoperative complications with substantial morbidity and mortality. The endoscopic approach to gastrojejunal anastomotic revision, transoral outlet reduction (TORe), is used as a minimally invasive treatment that aims to reduce the diameter of the gastrojejunal anastomosis, delaying gastric emptying and increasing satiety. With substantial published data supporting its use, TORe is an effective and safe bariatric endoscopic technique for addressing weight regain and dumping syndrome after RYGB.

Effect of Endoscopic Bariatric and Metabolic Therapies on Nonalcoholic Fatty Liver Disease: A Systematic Review and Meta-analysis.

BACKGROUND & AIMS: Weight loss via lifestyle intervention remains the mainstay of treatment for nonalcoholic fatty liver disease (NAFLD). Endoscopic bariatric and metabolic therapies (EBMTs) have recently been developed as an alternative treatment option for obesity. This study aimed to assess the effect of FDA-approved EBMTs on NAFLD. METHODS: We searched MEDLINE, EMBASE, Web of Science and Cochrane Central through December 2020 for studies that assessed changes in liver outcomes following EBMT. Primary Outcomes: Liver fibrosis. SECONDARY OUTCOMES: Liver biochemistry, steatosis, NAFLD histological changes and insulin sensitivity. The Grading of Recommendations, Assessment, Development, and Evidence (GRADE) approach was conducted to assess quality of evidence. RESULTS: Of 4994 potential studies, 18 studies with 863 patients were included. Average weight loss was 14.5% of initial weight at a 6-month follow-up. Primary outcomes: Following EBMT, liver fibrosis significantly reduced by standardized mean difference (SMD) of 0.7 (95% CI, 0.1, 1.3; P = .02). SECONDARY OUTCOMES: There were significant improvements in other NAFLD surrogates including alanine aminotransferase (-9.0 U/L; 95% CI, -11.6, -6.4; P < .0001), hepatic steatosis (SMD: -1.0; 95% CI, -1.2, -0.8; P < .0001) and histologic NAFLD activity score (-2.50; 95% CI, -3.5, -1.5; P < .0001). Other metabolic parameters including insulin resistance and waist circumference also significantly improved. The overall quality of the evidence for primary outcomes was low to very low. CONCLUSIONS: EBMTs appear effective at treating NAFLD with significant improvement in liver fibrosis. Given the worsening NAFLD pandemic and limitations of currently available therapies, EBMTs should be further investigated as a potential treatment option for this patient population.

Intragastric injection of botulinum toxin A for weight loss: A systematic review and meta-analysis of randomized controlled trials.

BACKGROUND AND AIM: Intragastric botulinum toxin A (BTA) injection is a potential treatment for weight reduction in obese patients. Current studies yielded conflicting results. We performed a systematic review and meta-analysis of randomized controlled trials (RCTs) to assess the efficacy of intragastric BTA injection for weight management. METHODS: We searched several databases to identify RCTs evaluating intragastric BTA injections for obesity. We applied random-effects models for all meta-analyses due to heterogeneity in the included studies. The mean difference (MD) and 95% confidence interval (CI) were calculated for continuous outcomes. RESULTS: A total of 6 RCTs including 192 subjects met the inclusion criteria and were included for the meta-analysis. Although the pooled data from six studies showed no difference in the absolute weight loss between intragastric BTA injection and control, subgroup analysis showed a significantly decreased absolute weight after a BTA injection dose ≥ 200 U (MD, -2.04 kg; 95% CI, -3.96 to -0.12) and after multiple injection regions in the stomach combined with diet control (MD, -4.44 kg; 95% CI, -6.54 to -2.33 kg) compared with the control. Regarding absolute weight loss, the impact of endoscopic ultrasound-guided injection and follow-up duration showed no difference. Intragastric BTA injection had a significant change in body mass index (MD, -1.25 kg/m2 ; 95% CI, -2.18 to -0.32 kg/m2 ) and prolonged gastric half-emptying time (MD, 11.37 min; 95% CI, -3.69 to 19.06 min). CONCLUSION: Intragastric BTA injection is effective for obesity treatment, and adequate doses (≥ 200 U), multiple gastric injection regions, and combined diet control are crucial. However, given the small sample size and limited power, caution should be exercised.

Primary Bariatric Procedures.

Obesity is pandemic. It is estimated that by 2030, half of the U.S. population will have obesity. Current treatment options for obesity includes lifestyle modification, pharmacotherapy, endoscopic bariatric and metabolic therapy (EBMT) and bariatric surgery. Over the past decades, an increasing number of EBMTs have been developed and become available. As a gastroenterologist, it is therefore important to become familiar with the available EBMTs as well as their safety and efficacy profiles in order to educate and expeditiously refer patients for the appropriate therapy when eligible. This chapter will review currently available and upcoming EBMTs. Details on how the procedures are performed, their mechanisms of action as well as data from pivotal studies will be summarized.

Endoscopic sleeve gastroplasty (ESG) for morbid obesity: how effective is it?

INTRODUCTION: ESG is an effective treatment for classes I and II obesity. However, the benefit of ESG in patients with morbid obesity (BMI ≥ 40 kg/m2) who decline surgery is not known. The study aims to compare the effectiveness and safety of ESG in all three obesity classes at 1 year. METHODS: We reviewed 484 patient records and identified 435 patients (class I: 105, class II: 169, class III: 161) who underwent ESG at our unit between May 2013 and March 2020. We compared their total body weight loss (%TBWL) and safety over 1 year. We used a linear mixed model (LMM) to analyse repeated measures of weight loss outcomes at 3, 6, 9, and 12 months for comparison between the three BMI groups. RESULTS: Among the 435 patients, 396 patients (class I: 99, class II: 151, class III: 146) completed 6 months, and 211 patients reached 1 year (class I: 50, class II: 77, class III: 84). There was no difference in age between the groups. In LMM analysis, adjusting for age and sex, we found ESG had a significantly higher TBWL, %TBWL, and BMI decline in class III compared to classes I and -II obesity at all time points (p < 0.001). The adjusted mean %TBWL at 1 year with classes I, -II, and -III obesity was 16.5%, 18.2%, and 20.5%, respectively. The overall complication rate and the hospital stay was identical in the three groups. CONCLUSION: ESG induced significant weight loss in all classes of obesity. In class III obesity, the weight loss achieved was significantly higher at 1 year. In patients declining or unsuitable for surgery, ESG could be considered as an alternative treatment option.

Hierarchical task analysis of endoscopic sleeve gastroplasty.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is a minimally invasive endoscopic weight loss procedure used to treat obesity. The long-term goal of this project is to develop a Virtual Bariatric Endoscopy (ViBE) simulator for training and assessment of the ESG procedure. The objectives of this current work are to: (a) perform a task analysis of ESG and (b) create metrics to be validated in the created simulator. METHODS: We performed a hierarchical task analysis (HTA) by identifying the significant tasks of the ESG procedure. We created the HTA to show the breakdown and connection of the tasks of the procedure. Utilizing the HTA and input from ESG experts, performance metrics were derived for objective measurement of the ESG procedure. Three blinded video raters analyzed seven recorded ESG procedures according to the proposed performance metrics. RESULTS: Based on the seven videos, there was a positive correlation between total task times and total performance scores (R = 0.886, P = 0.008). Endoscopists expert were found to be more skilled in reducing the area of the stomach compared to endoscopists novice (34.6% reduction versus 9.4% reduction, P = 0.01). The mean novice performance score was significantly lower than the mean expert performance score (34.7 vs. 23.8, P = 0.047). The inter-rater reliability test showed a perfect agreement among three raters for all tasks except for the suturing task. The suturing task had a significant agreement (Inter-rater Correlation = 0.84, Cronbach's alpha = 0.88). Suturing was determined to be a critical task that is positively correlated with the total score (R = 0.962, P = 0.0005). CONCLUSION: The task analysis and metrics development are critical for the development of the ViBE simulator. This preliminary assessment demonstrates that the performance metrics provide an accurate assessment of the endoscopist's performance. Further validation testing and refinement of the performance metrics are anticipated.

Intragastric Balloon Placement Induces Significant Metabolic and Histologic Improvement in Patients With Nonalcoholic Steatohepatitis.

BACKGROUND & AIMS: Obese patients with nonalcoholic steatohepatitis (NASH) are at risk for cirrhosis if significant weight loss is not achieved. The single fluid-filled intragastric balloon (IGB) induces meaningful weight loss and might be used in NASH treatment. We performed an open-label prospective study to evaluate the effects of IGB placement on metabolic and histologic features of NASH. METHODS: Twenty-one patients with early hepatic fibrosis (81% female; mean age, 54 years; average body mass index, 44 kg/m2) underwent magnetic resonance elastography (MRE) and endoscopic ultrasound with core liver biopsy collection at time IGB placement and removal at a single center from October 2016 through March 2018. The primary outcome measure was the changes in liver histology parameters after IGB, including change in nonalcoholic fatty liver disease activity score (NAS) and fibrosis score. We also evaluated changes in weight, body mass index, waist to hip ratio, aminotransaminases, fasting levels of lipids, fasting glucose, glycosylated hemoglobin, and MRE-detected liver stiffness. RESULTS: Six months after IGB, patients' mean total body weight loss was 11.7% ± 7.7%, with significant reductions in HbA1c (1.3% ± 0.5%) (P = .02). Waist circumference decreased by 14.4 ± 2.2 cm (P = .001). NAS improved in 18 of 20 patients (90%), with a median decrease of 3 points (range, 1-4 points); 16 of 20 patients (80%) had improvements of 2 points or more. Fibrosis improved by 1.17 stages in 15% of patients, and MRE-detected fibrosis improved by 1.5 stages in 10 of 20 patients (50%). Half of patients reached endpoints approved by the Food and Drug Administration of for NASH resolution and fibrosis improvement. Percent total body weight loss did not correlate with reductions in NAS or fibrosis. Other than post-procedural pain (in 5% of patients), no serious adverse events were reported. CONCLUSION: In a prospective study, IGB facilitated significant metabolic and histologic improvements in NASH. IGB appears to be safe and effective for NASH management when combined with a prescribed diet and exercise program. ClinicalTrials.gov no: NCT02880189.

Endoscopic trans-oral outlet reduction after bariatric surgery is safe and effective for dumping syndrome.

BACKGROUND: Dumping syndrome (DS) is a common complication of bariatric surgery. Treatments include dietary and behavioral changes, as well as pharmacotherapy and revision surgery. All can be costly or hard to adhere to. In recent years, evidence accumulates in favor of endoscopic trans-oral outlet reduction (TORe) as an effective treatment for DS, targeting the pathophysiology of rapid gastric clearance. The objective of this study is to assess the safety and efficacy of TORe for DS in a single referral center. METHODS: Patients after bariatric surgery suffering DS were followed, and data were retrospectively analyzed. Diagnosis and post-procedural assessment of DS were made clinically using Sigstad score. During the procedure, the anastomotic rim was cauterized. Afterwards, 2 non-interrupted "8-figure" sutures were placed, resulting in imbrication of additional gastric tissue on top of the anastomosis and narrowing to <1 cm at the end of the procedure. Patients were instructed to keep a liquid diet for 14 days and follow-up continued for 6 months. RESULTS: Between 8/2018 and 9/2019 TORe was carried out in 13 patients (M:F = 3:10) with mean age of 45.1 (range 25-56) and BMI of 33.5 (range 28.1-40.3). Average time since recent surgery was 5.5 years (range 1-9). Mean pre-procedure anastomosis diameter was 25.2 mm (range 15-30) and was reduced to a mean of 5.6 mm (range 5-10). Three patients (23%) were admitted overnight due to inability to drink which resolved spontaneously. No major complications were reported. At 6 months, the Sigstad score was significantly reduced (19.4 ± 3.6 vs 5.2 ± 5.5, P < 0.001), and 11/13 (85%) of patients had a complete resolution of their dumping symptoms. In addition, BMI decreased by a mean of 2.3 kg/m2 (-1 to 7.5, p = 0.002). CONCLUSION: TORe is a safe and effective treatment for patients suffering dumping syndrome and should be considered early in the treatment of DS.

Re-suturing after primary endoscopic sleeve gastroplasty (ESG) for obesity.

INTRODUCTION: Although primary endoscopic sleeve gastroplasty (P-ESG) is effective, some patients may require revision procedures to augment weight loss. We hypothesized that a non-surgical approach using redo ESG (R-ESG) might be a viable option in such patients. We aimed to assess the safety and efficacy of R-ESG following P-ESG to treat obesity. METHODS: We reviewed the outcome of patients who underwent R-ESG at our unit. We classified them as weight loss failure (WF)-< 10% total body weight (TBWL) at 6-months; weight regain (WR)-lost ≥ 10% TBWL and regained 50% of the maximum weight loss at or after 1-year; weight plateau (WP)-lost ≥ 10% TBWL but could not lose further over 3-months. We analyzed the feasibility, safety, and evaluated the efficacy of R-ESG in each group. RESULTS: Of the 482 patients who underwent P-ESG, 35 (7%) required R- ESG (WF-12, WR-12, WP-11). The mean age, weight, BMI (38.2 kg/m2), and the number of sutures used during P-ESG were similar between the groups. The nadir %TBWL was lowest in WF group compared to WR and WP (6.5% vs. 20% vs. 22.4%, p = 0.001). The mean BMI at R-ESG was 33.6 kg/m2. The time to R-ESG was longer in the WR group compared to WF and WP (22.3 vs. 13.4 vs. 13.7 months, p = 0.03). We placed a median of 3 (range 2-6) sutures. R-ESG was technically successful, and no serious complications occurred. All except two patients were discharged on the same day. The overall %TBWL achieved by R-ESG was significantly higher in WP (26%) as compared to WF (11.2%) and WR (12%), respectively (p = 0.001). CONCLUSION: The need for R-ESG after P-ESG is low. R-ESG is safe and induced weight loss in all patients. The maximum benefit was observed in WP.

The current state of bariatric endoscopy.

A variety of endoscopic bariatric and metabolic treatments (EBMTs) have been developed in recent years to combat the growing prevalence of obesity in the United States (US) and worldwide. This manuscript reviews the current state of bariatric endoscopy, detailing all US Food and Drug Administration (FDA) approved EBMTs including space-occupying intragastric balloons (IGBs), aspiration therapy, and endoscopic tissue apposition devices. Additionally, this review describes non-FDA approved treatments including additional IGBs, endoluminal bypass liners, duodenal mucosal resurfacing, and endoscopically placed anastomosis devices.

Endoscopic bariatric and metabolic therapies for non-alcoholic fatty liver disease: Evidence and perspectives.

Non-alcoholic fatty liver disease (NAFLD) has become the most common liver disease in industrialized countries because of the worldwide epidemic of obesity. Beyond metabolic complications, a subset of patients with NAFLD develop non-alcoholic steatohepatitis (NASH) with fibrosis, which is emerging as a leading cause of liver transplantation due to progression to cirrhosis and cancer. For these reasons, NAFLD is considered a public health burden. In recent years endoscopic bariatric and metabolic therapies (EBMT) have emerged as safe and effective for the treatment of obesity and type 2 diabetes mellitus. EBMT include gastric and duodenal devices and techniques such as intragastric balloons, endoscopic sleeve gastroplasty, endoscopic small bowel by-pass and duodenal mucosal resurfacing. Observational studies and pilot trials have revealed beneficial effects of EBMT on NAFLD as assessed by non-invasive parameters or histology. In this review we summarise current evidence for the efficacy and safety of EBMT in obese patients with NAFLD and examine future clinical applications.