Endoscopic and Pharmacologic Treatment of Obesity in Patients With Hereditary Polyposis Syndromes.

Patients with hereditary polyposis syndromes (HPS) are among the highest risk of multiple types of cancer. This risk is further magnified by comorbid obesity; however, HPS present unique risks for bariatric surgery. The advent of endoscopic bariatric and metabolic therapies along with advancements in the realm of antiobesity medications provides potential weight loss alternatives in this vulnerable population. We present 2 cases of patients with obesity and HPS successfully treated with intragastric balloons in combination with antiobesity medications.

Endoscopic sleeve gastroplasty for metabolic dysfunction-associated steatotic liver disease.

INTRODUCTION: Metabolic dysfunction-associated steatotic liver disease (MASLD, formerly nonalcoholic fatty liver disease - NAFLD) is a chronic liver condition linked to obesity and metabolic syndrome. It affects one-third of people globally and, in some cases, can lead to metabolic dysfunction-associated steatohepatitis (MASH, formerly nonalcoholic steatohepatitis, NASH) and fibrosis. Weight loss is crucial for the treatment of MASLD, but diet and lifestyle modifications often fail. AREAS COVERED: In recent years, endoscopic sleeve gastroplasty (ESG) has gained popularity as an effective and minimally invasive option for obesity treatment, with widespread use worldwide. We present a current overview of the most significant studies conducted on ESG for the management of obesity and MASLD. Our report includes data from published studies that have evaluated the impact of ESG on noninvasive hepatic parameters used to estimate steatosis and fibrosis. However, at present, there are no data available on liver histology. EXPERT OPINION: ESG has shown promising results in treating MASLD evaluated by noninvasive tests, but current data is limited to small, nonrandomized studies. More research is needed, particularly on the effects of ESG on histologically proven MASH. If future research confirms its efficacy, ESG may be incorporated into treatment guidelines in the future.

Endoscopic Management of Bariatric Surgery Complications: Fistulas, Leaks, and Ulcers.

Bariatric surgery is a safe and effective treatment option for patients with obesity and obesity-related comorbidities, with Roux-en-Y gastric bypass and sleeve gastrectomy being the two most common procedures. Despite the success of these interventions, adverse events are not uncommon. Endoscopic management has become first-line therapy when complications occur, and the armamentarium of devices and techniques continues to grow. This article focuses on the management of fistulas, leaks, and ulcers and also focuses on the etiology and endoscopic management strategy of each complication.

Endoscopic Sleeve Gastroplasty: Practical Considerations, Current Techniques, and Troubleshooting.

Endoscopic sleeve gastroplasty (ESG) has emerged as a safe and effective treatment for obesity over the past decade. This procedure, however, is technically challenging and requires frequent troubleshooting, even among experts. In this article the authors discuss current techniques, common pitfalls and adverse outcomes associated with ESG, how to avoid them, and how to address them if they occur.

How to Build an Endobariatric Practice: Set Up, Branding, and Marketing.

In the last decade there has been significant development of novel devices and techniques in the field of endoscopic bariatric and metabolic therapies (EBMTs). Bariatric endoscopy fulfills an unmet need within the current paradigm of obesity management. The expansion of this field is an important step in offering complete care to patients with obesity and metabolic disease. Nevertheless, information, mentorship and guidance through starting a practice in EBMTs are limited. We discuss important considerations when beginning a practice in obesity care with a focus on endobariatrics in a variety of practice settings.

Precision Medicine in Bariatric Procedures.

Obesity is a multi-factorial disease that is influenced by genetic, epigenetic, and environmental factors. Precision medicine is a practice wherein prevention and treatment strategies take individual variability into account. It involves using a variety of factors including deep phenotyping using clinical, physiologic, and behavioral characteristics, 'omics assays (eg, genomics, epigenomics, transcriptomics, and microbiomics among others), and environmental factors to devise practices that are individualized to subsets of patients. Personalizing the therapeutic modality to the individual can lead to enhanced effectiveness and tolerability. The authors review advances in precision medicine made in the field of bariatrics and discuss future avenues and challenges.

Successful Weight Loss in Adolescents with Overweight or Obesity Using a Swallowable Intragastric Balloon and Nutritional Oversight.

PURPOSE: Medical devices benefit patients living with overweight or obesity, but studies in the adolescent population are lacking. The goal of this study was to collect information on the performance and safety of a swallowable intragastric balloon program (SGBP) in adolescent patients. MATERIALS AND METHODS: Data were collected retrospectively on patients aged 15 to 17 years with body mass index (BMI) ≥ 27 kg/m2 who received the swallowable intragastric balloon (SGB) and associated lifestyle and nutritional change program. Patients had not responded to previous dietary and behavioral modification weight loss treatments and elected to undergo SGBP. The SGB was swallowed and filled with 550 mL of distilled water in an outpatient setting, and a multidisciplinary team delivered a lifestyle/nutritional change program. Mean % total body weight loss (%TBWL) was calculated for each patient compared with baseline. RESULTS: A total of 91 patients, 69 (75.8%) female and 22 (24.2%) male, underwent SGBP and completed follow-up through SGB passage at 4 months. Baseline mean ± SD age, weight, and BMI were 16.4 ± 0.77, 99.70 ± 21.33 kg, and 35.60 ± 5.59 kg/m2, respectively. After 4 months, mean weight and BMI were 86.37 ± 18.83 kg and 30.86 ± 5.16 kg/m2 respectively; %TBWL was 13.05 ± 7.64 (1-sided t-test, p < 0.0001). Most (80, 87.9%) reported no adverse events; 11/91 (12.1%) experienced an adverse event. Of these, 9/91 (9.9%) experienced nausea and/or vomiting; 1/91 (1.1%) reported abdominal pain only; 1/91 (1.1%) reported flatulence only. There were no serious adverse events or premature device removals. CONCLUSION: The SGBP provides safe and effective short-term weight loss in adolescents living with overweight and obesity.

Endobariatric systems: Strategic integration of endoscopic therapies in the management of obesity.

The escalating obesity pandemic and its comorbidities necessitate adaptable and versatile treatment strategies. Endobariatric and metabolic therapies (EBMTs) can be strategically employed in a multipronged approach to obesity management, analogous to the way chess systems are employed to seize opportunities and thwart threats. In this review, we explore the spectrum of established and developing EBMTs, examining their efficacy in weight loss and metabolic improvement and their importance for a tailored, patient-centric approach. The complexity of obesity management mirrors the intricate nature of a chess game, with an array of tactics and strategies available to address the opponent's moves. Similarly, the bariatric endoscopist employs a range of EBMTs to alter the gastrointestinal tract landscape, targeting critical anatomical regions to modify physiological reactions to food consumption and nutrient assimilation. Gastric-focused EBMTs aim to reduce stomach capacity and induce satiety. Intestinal-focused EBMTs target hormonal regulation and nutrient absorption to improve metabolic profiles. EBMTs offer unique advantages of reversibility, adjustability and minimal invasiveness, allowing them to be used as primary treatments, adjuncts to pharmacotherapy or tools to address post-bariatric surgery weight recidivism. However, sub-optimal adoption of EBMTs due to lack of awareness, perceived costs and limited training opportunities hinders their integration into standard obesity management practices. By strategically integrating EBMTs into the broader landscape of obesity care, leveraging their unique advantages to enhance outcomes, clinicians can offer a more dynamic and personalized treatment paradigm. This approach, akin to employing chess systems to adapt to evolving challenges, allows for a comprehensive, patient-centric management of obesity as a chronic, complex and relapsing disease.

Evaluating the Safety of the Intragastric Balloon: Spanish Multicenter Experience in 20,680 Cases and with 12 Different Balloon Models.

INTRODUCTION: Intragastric balloon (IGB) is a minimally invasive and reversible option for obesity treatment. There is a worldwide growing number of different IGB models. The efficacy and safety profile for each model must be demonstrated. We aim to evaluate IGB safety profile according to the experience of the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS: A survey of 37 IGBs safety-related questions was sent to all GETTEMO members, to retrospectively collect a multicenter Spanish registry. Incidence, causes, and resolution of both major and minor complications and adverse events (AEs), including legal consequences, differentiated for each balloon model were evaluated. Secondary outcome was weight loss data to confirm efficacy. RESULTS: Twenty-one Spanish hospitals experienced in IGBs responded. The overall data encompassed 20,680 IGBs, including 12 different models. Mean %TBWL of 17.66 ± 2.5% was observed. Early removal rate due to intolerance was 3.62%. Mean major complications rate was 0.70% (> 1% in Spatz2, HB, and Spatz3 models), mainly complicated gastric ulcer. Minor AEs rate was 6.37%, mainly esophagitis. Nine cases (0.04%) required surgery. A single case of mortality (0.0048%) occurred. Seven lawsuits (0.0034%) were received, all with favorable resolution. CONCLUSIONS: In the Spanish experience accumulating 20,680 IGBs and including 12 different balloon models, a low incidence rate of major complications and minor AEs are observed (0.70% and 6.37%, respectively), mostly resolved with medical/endoscopic management. IGB shows good tolerance and efficacy profile. These safety data are within the accepted quality standards.

Early safety of endoscopic sleeve gastroplasty in super obesity (body mass index > 50).

BACKGROUND: The prevalence of super obesity (body mass index [BMI] > 50) continues to rise. However, the adoption of bariatric surgery in this population remains very low. There are limited studies evaluating the utility of endoscopic sleeve gastroplasty (ESG) in super obesity. OBJECTIVES: The purpose of this study is to evaluate the short-term safety profile of ESG in patients with super obesity using data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database. SETTING: United States. METHODS: We retrospectively analyzed patients who underwent ESG and sleeve gastrectomy (SG) from 2016 to 2021. Patients with BMI >50 who underwent ESG were compared to ESG patients with BMI <50 and also SG patients with BMI >50. Primary outcomes included the incidence of severe adverse events (AEs), hospital readmission, reintervention, and reoperation within 30 days of the primary procedure. Secondary outcomes included procedure time, hospital length of stay, and total body weight loss at 30 days. RESULTS: There were no significant differences in AE, reoperations, hospital readmissions, or reinterventions for patients with super obesity undergoing ESG, compared to patients with BMI below 50. Mean total body weight loss was greater in patients with super obesity. There were no significant differences in AEs for patients with super obesity who underwent ESG versus SG, although ESG patients had more hospital readmissions, reinterventions, and reoperations. CONCLUSIONS: ESG may be performed safely, with comparable safety to SG, in patients with BMI as high as 70. However, further studies are needed to validate the feasibility and long-term efficacy prior to clinical implementation.

Outcomes of concomitant antiobesity medication use with endoscopic sleeve gastroplasty in clinical US settings.

Background: To evaluate the weight loss outcomes of the large US cohort of patients undergoing endoscopic sleeve gastroplasty (ESG) with or without concomitant anti-obesity (AOM) use. Methods: We performed a retrospective analysis of adult patients who underwent ESG from seven different sites, from January 1, 2020 to November 30, 2022. Percent total body weight loss (%TBWL) and %excess weight loss (%EWL) were calculated based on baseline weight at the procedure. Medication use was considered if the subject received a prescribed AOM during the study period. SPSS (version 29.0) was used for statistical analyses. Results: A total of 1506 patients were included (1359 (90.2 %) no AOM use and 147 (9.8 %) AOM use). Patients who were on an active AOM at the time of the procedure had a significantly lower TBWL% as compared to patients not on AOMs at 6 months. At the 24-month visit, patients who were prescribed AOMs after the 12-month visit had a significantly higher TBWL% and EWL% as compared to patients who were on active AOM at the time of the procedure. There was no significant difference between classes of medications at any time point, however, patients on a GLP-1RA had a trend towards improved weight loss at 18 and 24 months. Conclusion: In this large, real-world cohort of patients from the United States, data signal that with the use of pharmacotherapy at the appropriate time, patients can achieve optimal results.

How to establish an endoscopic bariatric practice.

Obesity is a chronic, progressive, and relapsing disease of excess adiposity that contributes to more than two hundred medical conditions and is projected to affect more than half the adult population of the United States by the year 2030. Given the limited penetrance of traditional bariatric surgery, as well as the cost and adherence barriers to anti-obesity medications, there is growing interest in the rapidly evolving field of endoscopic bariatric therapies (EBTs). EBTs are minimally invasive, same-day, per-oral endoscopic procedures and include endoscopic sleeve gastroplasty, intragastric balloons, and endoscopic bariatric revisional procedures. This field represents an exciting and innovative subspecialty within gastroenterology. However, building a successful endoscopic bariatric practice requires intentional, coordinated, and sustained efforts to overcome the numerous obstacles to entry. Common barriers include acquisition of the technical and cognitive skillset, practice limitations including the availability of nutrition counseling, facility capabilities, direct-to-consumer marketing, and financial pressures such as facility and anesthesia fees. As the highest-volume center for metabolic and bariatric endoscopy in the United States, we provide insights into successfully establishing an endoscopic bariatric program.

Update on Endoscopic Treatments for Obesity.

PURPOSE OF REVIEW: Increased morbidity seen with rising obesity rates continues to place an unheralded burden on our health system. Lack of higher bariatric surgery utilization and limitations with lifestyle modification and pharmacotherapy highlights the need for additional therapies for obesity. Endoscopic bariatric and metabolic therapies (EBMT) are effective, safe treatments for obesity. Current FDA-approved EBMT are confined to gastric modalities while small bowel directed therapies are still considered investigational. This review highlights current modalities of EBMT. RECENT FINDINGS: Many randomized controlled trials have been performed, including both open label and sham-controlled, which have demonstrated safety and efficacy of EBMT over lifestyle therapy alone. In addition, emerging evidence from clinical experience further supports EBMT for treatment of obesity. Current evidence supports the safety and efficacy of EBMT for obesity treatment in conjunction with lifestyle therapy. They can also be used concurrently with weight loss medications to increase total weight loss.

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.

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.

IFSO Consensus on Definitions and Clinical Practice Guidelines for Obesity Management-an International Delphi Study.

INTRODUCTION: This survey of international experts in obesity management was conducted to achieve consensus on standardized definitions and to identify areas of consensus and non-consensus in metabolic bariatric surgery (MBS) to assist in an algorithm of clinical practice guidelines for the management of obesity. METHODS: A three-round Delphi survey with 136 statements was conducted by 43 experts in obesity management comprising 26 bariatric surgeons, 4 endoscopists, 8 endocrinologists, 2 nutritionists, 2 counsellors, an internist, and a pediatrician spanning six continents over a 2-day meeting in Hamburg, Germany. To reduce bias, voting was unanimous, and the statements were neither favorable nor unfavorable to the issue voted or evenly balanced between favorable and unfavorable. Consensus was defined as ≥ 70% inter-voter agreement. RESULTS: Consensus was reached on all 15 essential definitional and reporting statements, including initial suboptimal clinical response, baseline weight, recurrent weight gain, conversion, and revision surgery. Consensus was reached on 95/121 statements on the type of surgical procedures favoring Roux-en-Y gastric bypass, sleeve gastrectomy, and endoscopic sleeve gastroplasty. Moderate consensus was reached for sleeve gastrectomy single-anastomosis duodenoileostomy and none on the role of intra-gastric balloons. Consensus was reached for MBS in patients > 65 and < 18 years old, with a BMI > 50 kg/m2, and with various obesity-related complications such as type 2 diabetes, liver, and kidney disease. CONCLUSIONS: In this survey of 43 multi-disciplinary experts, consensus was reached on standardized definitions and reporting standards applicable to the whole medical community. An algorithm for treating patients with obesity was explored utilizing a thoughtful multimodal approach.

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.

Meta-analysis: Impact of intragastric balloon therapy on NAFLD-related parameters in patients with obesity.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) is a leading cause of chronic liver disease affecting approximately 25% of adults in the western world. Intragastric balloon (IGB) is an endoscopic bariatric therapy -a therapeutic endoscopic tool that has shown promise in inducing weight loss. Its role in the treatment of NAFLD is yet to be established. AIM: To evaluate the effect of IGB as a treatment option in NAFLD. METHODS: We searched MEDLINE (PubMed) and EMBASE from inception to September 2022. We included studies evaluating the impact of IGB on obesity with the assessment of one or more liver-related outcomes and studies primarily evaluating the impact of IGB on NAFLD. We included comparative and non-comparative studies; primary outcomes were liver-related NAFLD surrogates. RESULTS: We included 19 studies with 911 patients. IGB demonstrated an effect on NAFLD parameters including NAFLD activity score (NAS): mean difference (MD): -3.0 [95% CI: -2.41 to -3.59], ALT: MD: -10.40 U/L [95% CI: -7.31 to -13.49], liver volume: MD -397.9 [95% CI: -212.78 to 1008.58] and liver steatosis: MD: -37.76 dB/m [95% CI: -21.59 to -53.92]. There were significant reductions in non-liver-related outcomes of body weight, BMI, glycated haemoglobin and HOMA-IR. CONCLUSION: Intragastric balloons may play an important role in addressing the treatment gap in NAFLD management.