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Summary People with excess weight and obesity compose 64.5% of the Ecuadorian population. The Allurion Intragastric Balloon (IGB) is a noninvasive weight loss alternative for patients ineligible for other bariatric procedures. The impact of the procedure on weight loss and body composition, along with insertion complications and secondary effects were investigated. This is a single‐centre retrospective study of patients who underwent Allurion IGB insertion from July 2020 to March 2021. This study followed 167 patients for 12 months after EIGB insertion. Our sample had a mean initial weight of 83.6 ± 13.8 kg and initial body mass index of 31.3 ± 3.6 kg/m2. Percentage total weight loss was 4.65% ± 0.56%, 8.5% ± 4%, 12.29% ± 4.65%, 15.68% ± 5.22%, 17.14% ± 6.05%, and 14.68% ± 18.02% for months 1, 2, 3, 4, 6 and 12, respectively. In the fourth month, 92 patients (56.4%) had lost ≥50% excess body weight; at month 6, 104 patients (67.5%) achieved this goal. Regarding body composition, body fat percentage started at 38.99% ± 7.92%, and at month 6 was 35.67% ± 6.84%, this was the only significance in the statistical analysis.This study aligns with the literature's safety and efficacy results for the Allurion IGB while illustrating the need for further research regarding weight behaviour after its expulsion. [ABSTRACT FROM AUTHOR]

Key Clinical Message: Gastric outlet obstruction can be a dangerous complication of intragastric balloons, as it can result in severe metabolic alkalosis. As weight loss procedures and medical tourism become more popular, physicians should have a high index of suspicion for complications of invasive procedures, particularly in returning travelers. Intragastric balloons for weight loss have decreased in frequency in the United States. However, they are still frequent in low‐ and middle‐income countries. Severe complications occur in less than 3% of patients who undergo this procedure. Herein, we present a case of gastric outlet obstruction, severe metabolic alkalosis, and refeeding syndrome in a patient returning from the Dominican Republic. She presented with 2 weeks of emesis and obstipation, followed by a pre‐syncope and altered mental status. An intragastric mass was observed on computerized tomography, which was characterized as an intragastric balloon and retrieved endoscopically. All metabolic derangements were corrected, and the patient improved without sequelae. As weight loss procedures and medical tourism become more popular, physicians should have a high index of suspicion for complications of invasive procedures, particularly in returning travelers. [ABSTRACT FROM AUTHOR]

Summary: 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. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effect of gastric distension, induced using a gastric 'barostat', on the secretion of glucose‐dependent insulinotropic polypeptide (GIP) and glucagon‐like peptide‐1 (GLP‐1) in the presence and absence of small intestinal nutrients in healthy individuals. Materials and Methods: Eight healthy participants (two females, six males, mean age 69.3 ± 1.2 years, body mass index 23.5 ± 0.8 kg/m2) were each studied on four occasions when they received an intraduodenal infusion of either (i) 0.9% saline or (ii) glucose delivered at a rate of 3 kcal/min both with, and without, an intragastric balloon with the pressure set to 8 mmHg above the intragastric minimum distending pressure. Results: Following intraduodenal saline or glucose infusion, there was no difference in plasma GLP‐1 with or without gastric distension (P = 1.00 for both saline and glucose infusions). There was also no difference in plasma GIP with or without gastric distension (P = 1.00 for saline infusion and P =.99 for glucose infusion). Conclusions: Gastric distension, either alone or during small intestinal glucose exposure, does not stimulate incretin hormone secretion significantly in healthy humans. [ABSTRACT FROM AUTHOR]

Background and aims: Effective therapy for clinically significant fibrosis in nonalcoholic fatty liver disease (NAFLD) is an unmet need. Data on the effectiveness of endoscopic placement of intragastric balloon (IGB) in patients with NAFLD are limited. In this study, we evaluated the impact of IGB placement in NAFLD patients with advanced fibrosis. Methods: We retrospectively assessed the effects of the Orbera™ fluid‐filled IGB in a cohort of obese patients with liver stiffness ≥9.7 kPa (corresponding to F3‐F4). Patients with endoscopic signs of portal hypertension were excluded. Changes in metabolic and liver parameters from baseline to follow‐up (6 mo) were assessed. Results: A total of 26 obese patients, aged 53 [44 ‐ 62] years, with BMI 35.1 ± 4.7 kg/m2 were included. All patients achieved a significant body weight loss (106 ± 19.7 vs. 92 ± 18.3 kg, P <.001) and waist circumference reduction (116 ± 13.3 vs. 104 ± 13.4 kg, P <.001) at 6‐month follow‐up after IGB placement. Weight loss induced by IGB lowered blood glucose (140 [112; 169] vs. 118 [94; 144] mg/dl, P <.01), glycated hemoglobin (7.5 ± 1.3 vs. 6.6 ± 1.2%, P <.001), FIB‐4 (3.2 ± 0.7 vs. 2.7 ± 0.8, P <.001), liver stiffness (13.3 ± 3.2 vs. 11.3 ± 2.8 kPa, P <.001) and controlled attenuation parameter (355 [298‐400] vs. 296 [255‐352] dB/m, P <.01). Gastroesophageal reflux symptoms were common, but no severe adverse event was observed. Conclusion: Obese patients with advanced liver fibrosis, treated with 6‐month IGB, can achieve regression of fibrosis as assessed by reduction of liver stiffness and FIB‐4. Randomized controlled trials are needed to confirm these findings. [ABSTRACT FROM AUTHOR]

Introduction: Endoscopic intragastric balloon (IGB) placement has been performed in Japan since 2004. The nationwide surveys were repeatedly carried out to confirm the effectiveness and safety of IGB in Japan. We herein present the accumulated results. Methods: Twenty‐six Japanese endoscopists personally imported products of the BioEnterics Intragastric Balloon (BIB)/Orbera system after completing the training courses in Japan. Mail surveys were posted to them every 2 years from 2010. This study included the accumulated data of the six surveys, and excluded data from non‐Japanese patients and the Orbera365 data. Results: Between 2004 and 2019, 399 obese Japanese patients underwent IGB treatment using the BIB/Orbera system. The incidence rates of early removal of IGB within 1 week and complications due to IGB were 4.8% and 6.1%, respectively. The average percent excess weight loss (%EWL) and percent total weight loss (%TWL) at IGB removal were 46.6% and 11.5%, and successful weight loss, defined as %EWL ≥ 25% or %TWL ≥ 10%, was achieved in 65.6% or 54.5% of the patients, respectively. Multivariate analyses revealed that older age and larger saline filling volume were independent predictors of successful weight loss. At 1 year after IGB removal, successful weight loss defined by the %EWL and %TWL was maintained in 44.7% and 34.1% of the patients, respectively. Conclusion: IGB therapy using the BIB/Orbera system has been safely and effectively performed in Japan. The successful weight loss may be associated with older age and larger saline filling volume. [ABSTRACT FROM AUTHOR]

Objective: The mechanism of action of intragastric balloons in the treatment of obesity is not fully understood. One of the hypotheses is that balloons might have an effect on the fundus, the area of ghrelin production. Methods: Participants were randomized to a 13‐week period of sham or balloon treatment followed by a 13‐week period of balloon therapy in everyone. Blood samples for ghrelin levels were taken in the fasting state and after a breakfast at the start, after 13 and 26 weeks. Biopsies for ghrelin cell immunohistochemistry were taken from the fundus at endoscopy. Results: Seven participants entered the balloon–balloon (BB) group and 11 the sham–balloon (SB) group. Despite a considerable weight loss, a median −17.9 kg (interquartile ranges −23.8 to −0.5) in the BB group and −18.3 kg (−22.7 to −14.7) in the SB group, fasting ghrelin and meal‐induced ghrelin response did not change. In the SB group, the number of ghrelin cells increased significantly (p 0.001) from 110.6 (83.6–118.9) to 160.2 (128.5–223.0) while on sham treatment and returned to initial levels, 116.3 (91.7–146.9) (p 0.001), when they received their first balloon. No significant changes in ghrelin cell numbers were observed in the BB group. Conclusion: In participants without a balloon, weight loss induced an increase in ghrelin cell numbers in the fundus, which was annulled by the subsequent placement of a balloon. The effect of a balloon might be explained by effects on ghrelin cell numbers or ghrelin cell activity. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Summary: Objective: Obesity is a major public health issue with significant impact on quality of life, morbidity and mortality rates. It is estimated that if the current trends continue, 18% of men and 21% of women worldwide will be obese by 2025. All the current therapies are not optimal due to limited efficacy or safety; thus, there is a need for additional devices for the treatment of obesity. This study aimed to examine the safety, tolerability, and efficacy of a biodegradable encapsulated Epitomee device for weight loss. The technology is based on absorbent pharmaceuticals polymers and bonding materials that self‐expand in the stomach to create a pH‐sensitive super absorbent gel structure for weight loss. Methods: A prospective, 12‐week twice daily use of the encapsulated device in patients with body mass index of 27–40 kg m−2. Efficacy endpoints were the percent total body weight loss (%TBWL), proportion of participants with 5% TBWL and changes in cardio‐metabolic markers. Safety analysis included evaluation of adverse events, laboratory and endoscopic findings. Results: Overall, 52 patients completed the study. TBWL per intension‐to‐treat analysis was 3.68 ± 3.07% (3.23 ± 2.69 kg) and 4.52 ± 2.97% (3.95 ± 2.57 kg) per protocol. No device serious adverse effects reported. The most common adverse events were headache (18.1%), viral infection (11.5%), abdominal discomfort (10.1%), bloating (7.9%), nausea and constipation (5% each) and flatulence (4.3%). Endoscopy in 26 patients revealed mild, asymptomatic gastric/duodenal erythema without erosions in five patients. Conclusions: Twelve weeks of Epitomee capsules treatment combined with lifestyle counselling resulted in 3.68–4.52% of TBWL. With continued research, the Epitomee capsules have considerable potential to become a non‐invasive, safe and effective treatment option for weight loss. [ABSTRACT FROM AUTHOR]

Abstract: Obesity is a public health epidemic associated with a number of comorbidities, most notably type 2 diabetes and hypertension, as well as elevated all‐cause mortality. The treatment for obesity and its associated comorbidities has most recently expanded into the field of bariatric endoscopy. This field bridges a gap between lifestyle counseling with or without pharmaceutical treatment and the most effective treatment of obesity, bariatric surgery. Because of its minimally invasive nature, bariatric endoscopic therapy has the potential to appeal to the large sector of the obese population that resists surgery, as well as those early in the onset of obesity. To date, five endoscopic devices have been approved by the U.S. Food and Drug Administration for the treatment of obesity, and many more are in development, undergoing clinical trials, or being used around the world. Here, we present the current state of the field, highlight recent developments, and describe the clinical outcomes of these minimally invasive procedures in terms of weight loss, improvement in metabolic profile, and reduction in comorbidities. [ABSTRACT FROM AUTHOR]

Background Lifestyle interventions are often ineffective in the treatment of pediatric obesity. Weight loss devices have been introduced for the temporary nonsurgical treatment of morbid obesity. Objective The aim of the study is to evaluate the efficacy of Obalon Intragastric Balloon on weight loss and on metabolic and cardiovascular parameters in a pediatric population with severe obesity. Methods We enrolled 10 children with severe obesity. In all patients anthropometric parameters, biochemical tests, ultrasound liver examination and blood pressure monitoring were evaluated at the time of insertion and after removal of device. Results The Obalon had a positive effect on decrease of weight, body mass index and percentage of excess body weight within 3 months from placement. Moreover, this safe minimally invasive device improves the cardio-metabolic profiles of obese children. Conclusions The Obalon could be a useful tool in the difficult management of pediatric patients with morbid obesity, inducing in short-term a meaningful weight loss. [ABSTRACT FROM AUTHOR]

Background The intragastric balloon, filled with air or liquid is used before elective bariatric surgery because its efficacy is limited. This might be the consequence of altered gastric functions. Therefore, we aimed to investigate, in an animal model, the changes in gastric motility and emptying induced by long-term insertion of a balloon used for weight reduction. Methods Ten Göttingen mini-pigs were allocated into two groups with and without an intragastric balloon for 5 months. Balloons were inserted under endoscopy during general anesthesia and were filled with 350 mL of air. Gastric emptying was evaluated by scintigraphy. Gastric volume was measured by single photon emission computed tomography and proximal gastric compliance obtained using an electronic barostat. Changes in vagal tone were assessed by heart rate variability (HRV). Key Results After balloon insertion, gastric volume was significantly increased (2047 ± 114.8 cm3 after vs 1674 ± 142.5 cm3 before insertion, P < 0.05). Gastric compliance was also larger in balloon group (219 ± 23.4 mL mmHg−1 in balloon vs 168 ± 7.7 mL mmHg−1 in control group). Gastric emptying was reduced after insertion of the balloon ( T1/2 = 204 ± 28.8 min vs 159 ± 25.4 before vs after insertion). High frequency components of the spectral analysis of HRV, representing vagal tone, were increased in balloon group. Conclusions & Inferences The proximal stomach was enlarged after the insertion of a balloon in the stomach as a consequence of an increased gastric compliance. This change in compliance was probably causative for a reduction in gastric emptying rate of solids. These alterations were associated with increased vagal tone. [ABSTRACT FROM AUTHOR]

Here we present the case of Candida albicans colonization on an intragastric balloon placed for weight loss. A 52-year-old obese woman achieved a BMI reduction of 10.9 kg/m2 within 7 months as a result of a Bio Enterics Intragastric Balloon and a well-balanced, low-calorie diet. During endoscopy for balloon removal, the balloon, which was well impacted in the gastric fundus, was found to be lime green in color with clusters of cone-shaped cultures on its surface. Microbiology assessment revealed the presence of Candida albicans, although the patient was totally asymptomatic. [ABSTRACT FROM AUTHOR]

Pharmacobezoar formation is a very rare complication that occurs in cases of altered gastrointestinal motility or to a background of disturbed anatomy of the gastrointestinal tract. The case of an obese and depressed patient treated by an intragastric balloon for weight loss, who was revealed to have a pharmacobezoar during endoscopy for early balloon removal, is presented. The possible causes of pharmacobezoar formation in such a patient treated with an intragastric balloon are discussed. [ABSTRACT FROM AUTHOR]