Endoscopic Approaches to Obesity Management.

The field of endoscopic bariatric and metabolic therapy has rapidly evolved from offering endoscopic treatment of weight regain following bariatric surgery to providing primary weight loss options as alternatives to pharmacologic and surgical interventions. Gastric devices and remodeling procedures were initially designed to work through a mechanism of volume restriction, leading to earlier satiety and reduced caloric intake. As the field continues to grow, small bowel interventions are evolving that may have some effect on weight loss but focus on the treatment of obesity-related comorbidities. Future implementation of combination therapy that utilizes both gastric and small bowel interventions offers an exciting option to further augment weight loss and alleviate metabolic disease. This review considers gastric devices and techniques including space-occupying intragastric balloons, aspiration therapy, endoscopic tissue suturing, and plication interventions, followed by a review of small bowel interventions including endoluminal bypass liners, duodenal mucosal resurfacing, and endoscopically delivered devices to create incisionless anastomoses.

Weight-Loss Endoscopy Trial: A Multicenter, Randomized, Controlled Trial Comparing Weight Loss in Endoscopically Implanted Duodenal-Jejunal Bypass Liners versus Intragastric Balloons versus a Sham Procedure.

INTRODUCTION: Obesity is associated with reduced life expectancy and various comorbidities. Surgical interventions are effective but accompanied by the risk of serious complications. Less invasive endoscopic procedures mainly comprise the intragastric balloon (IB) and the duodenal-jejunal bypass liner (DJBL). A randomized, sham-controlled study comparing both procedures has not been undertaken so far. METHODS: We performed a randomized, patient- and assessor-blinded, controlled trial comparing weight loss in IB versus DJBL versus a sham procedure (2:2:1 ratio). Patients with a BMI >35 kg/m2 or >30 with obesity-related comorbidities were included. The IB was removed after 6 months and the DJBL after 12 months. The main objective was successful weight loss (>10% from baseline) 12 months after explantation of the devices. Secondary outcomes were changes in comorbidities, quality of life, and complications. RESULTS: Thirty-three patients were randomized. Recruitment has to be stopped suddenly in after the DJBL device lost its CE mark in Europe. In all, 11 patients received DJBL, 15 IB, and 7 were allocated to the sham group. Blinding was feasible in all patients. Weight decreased from baseline until explantation (DJBL: 129.4 ± 28.3 kg to 107.4 ± 16.7 kg; IB: 118.3 ± 22.8 kg to 107.4 ± 25.7 kg; sham: 134.6 ± 18.0 kg to 131.2 ± 14.3 kg), but patients regained weight almost to the baseline level 12 months after explantation. Only 1 patient in IB group reached the primary endpoint. Severe device-related complications were very rare. CONCLUSION: Endoscopic bariatric procedures failed to achieve effective weight loss 12 months after explantation of the devices. The results of this trial need to be interpreted with caution due to its early termination.

Weighing your options-intragastric balloon versus semaglutide.

INTRODUCTION: Over half of Americans and up to 78% of US Veteran population meet criteria for obesity. Perioperatively placed intragastric balloon (IGB) can accelerate weight loss goals for safe surgical candidacy, however weight regain is common after removal. Glucagon-like peptide-1-receptor agonists (GLP1RA) may provide a more sustainable weight loss solution after surgery. We hypothesize that weight regain will be less at 1 year after initiation of GLP1RA than IGB placement in Veterans. METHODS: Retrospective review of prospective databases of perioperatively placed intragastric balloon cohort from 1/2019-1/2023 compared to patients who received initiatory GLP1RA from 6/2021-8/2022 at a VA Medical Center(VAMC). All patients were enrolled in the VAMC MOVE! multidisciplinary weight management program for a minimum of 12 weeks. Outcomes measured were patients' weights at 0, 3, 6, and 12 months and weight change for these intervals. Exclusion criteria included history of bariatric surgery and incomplete weight loss data. RESULTS: Two-hundred-twenty-three patients met inclusion criteria; 110 (49%) patients excluded. Mean age was 54 ± 11 years, the majority (78, 69%) were male, and the mean initial BMI was 37 ± 5.9 kg/m2. Seventeen (15%) patients underwent IGB placement and 96 (85%) patients received semaglutide. Weight (kg) change was measured at intervals: 0-3 months:- 11.8(- 17,- 9.5) IGB vs. - 5.1(- 7.4,- 2.3) semaglutide, p < 0.0001; 0-6 months:- 12.7(- 18.4,- 9.9) vs. - 9.4(- 12.6,- 6.1), p = 0.03; 3-6 months:- 0.5(- 2.3,2.3) vs. - 4.3(- 6.8,- 1.6), p < 0.0001; 6-12 months:3(0,7.3) vs. - 1.9(- 4.7,1), p = 0.0006. CONCLUSION: Weight loss occurs more rapidly in the first 6 months after intragastric balloon placement compared to semaglutide (- 12.7 vs. - 9.4 kg, p = 0.03). Despite ongoing attendance in a comprehensive weight loss program, weight regain is common after IGB removal by an average of 3 kg (23.6%) at 1 year. In contrast, patients on GLP1RA (semaglutide) continue to lose weight during this period. Further studies are needed to determine if optimal long-term outcomes may result from combination therapy with intragastric balloon and semaglutide.

Effect of gastric distension with concurrent small intestinal saline or glucose infusion on incretin hormone secretion in healthy individuals: A randomized, controlled, crossover study.

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.

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.

Intragastric Balloon in Obese Compensated Nonalcoholic Steatohepatitis Cirrhosis Patients Is Safe and Achieves Significant Weight Reduction at 6-Months.

BACKGROUND AND STUDY AIMS: Weight reduction is the mainstay treatment for Nonalcoholic steatohepatitis (NASH). intragastric balloon (IGB) placement has proven benefit in terms of weight reduction. The aim of the present study is to assess the safety and efficacy of IGB placement in compensated NASH cirrhosis. PATIENTS AND METHODS: Nonalcoholic steatohepatitis cirrhosis patients with CTP ≤ 7, BMI of > 30, and who were unable to achieve weight reduction with lifestyle modification in past 3 months were prospectively enrolled. Spatz3™ adjustable gastric balloon was placed endoscopically. Primary objective was to determine efficacy in weight loss at 6 months, with secondary objectives of reduction in hepatic venous pressure gradient (HVPG), liver fat (controlled attenuation parameter, CAP), liver stiffness measurement (LSM) and clinical events as well as the tolerability and adverse events due to IGB placement. RESULTS: Altogether 56 cirrhosis patients, with a baseline BMI of 35.24 ± 3.92 and a CTP score of 6.27 ± 1.28 underwent IGB placement. The absolute weight reduction achieved was 15.88 kg (- 16.46%) and reduction in BMI was - 10.1% at 6 months. The percentage total body weight loss of ≥ 10% was achieved in 31 (55.35%) patients. The reduction in HVPG at 6-months was 11.12% (n = 16, 14.18 ± 2.12 to 12.60 ± 1.67 mmHg). The mean reduction in LSM was 28.6% and in CAP was 10.09%. Three (5.36%) patients required removal of IGB before 6-months due to persisting vomiting. No patient developed new-onset decompensation or any serious adverse event. CONCLUSION: IGB placement is a safe, well tolerated and effective option for reduction in weight and portal pressure in compensated obese cirrhosis patients. TRIAL REGISTRY: Clinicaltrails.gov identifier no: NCT03753438.

Results of intragastric balloon treatment and evaluation of patient satisfaction.

Introduction: Endoscopic bariatric therapies are an alternative treatment method for patients who do not respond to diet, exercise and drug therapy or who are not yet candidates for surgery or who are suitable and hesitant to undergo surgery. In this study, we aimed to evaluate our intragastric balloon (IGB) treatment results and the satisfaction of the patients in the light of the literature. Materials and Methods: The study was conducted by retrospectively evaluating the patients who underwent IGB application in the gastroenterology and general surgery endoscopy units of our hospital. Results: Sixty-eight patients who had IGB for 6 months were evaluated. The mean weight given was 10 (0-25) kg and the mean body mass index (BMI) decrease was 3.6 (0-9) kg/m2. A statistically significant decrease was obtained between the initial weight and BMI of our patients and the weight and BMI at the end of the 6th month (P ≤ 0.0001). Thirty-five (51.5%) patients reported that they were satisfied with the procedure, while 33 (48.5) reported that they were not satisfied. conclusion: IGBs for the treatment of obesity are an attractive form of treatment because they provide minimally invasive, temporary and significant weight loss. Patients need to be repeatedly told that diet and lifestyle changes should be followed in the treatment of IGB. Thus, we believe that possible disappointments can be prevented.

A novel intragastric balloon for treatment of obesity and type 2 diabetes. A two-center pilot trial.

BACKGROUND AND AIMS: Obesity with type-2 diabetes is a global challenge. Lifestyle interventions have limited effect for most patients. Bariatric surgery is highly effective, but resource-demanding, invasive and associated with serious complications. Recently, a new intragastric balloon was introduced, not requiring endoscopy for placement or removal (Elipse™, Allurion Inc., Natick, MA). The balloon is swallowed in a capsule and filled with water once in the stomach. The balloon self-deflates after 4 months and is naturally excreted. The present trial investigated balloon feasibility, safety and efficacy in patients with obesity and type-2 diabetes. PATIENTS AND METHODS: We treated 19 patients, with type-2 diabetes and body mass index (BMI) of 30.0-39.9 kg/m2 at two Norwegian centers with the Elipse balloon. Patient follow-up during balloon treatment mimicked real-world clinical practice, including dietary plan and outpatient visits. The primary efficacy endpoints were total body weight loss (TBWL) and HbA1c at weeks 16 and 52. RESULTS: All patients underwent balloon insertion uneventfully as out-patients. Mean TBWL and HbA1c reduction after 16 and 52 weeks of balloon insertion was 3.9% (95%CI 2.1-5.7) and 0.8% (95%CI 1.9-3.5); and 7 (95%CI 4-10), and 1 (95%CI -6 to 9) mmol/mol, respectively. Adverse events occurred in two patients (10.5%): one developed gastric outlet obstruction, managed by endoscopic balloon removal; the other excessive vomiting and dehydration, managed conservatively. CONCLUSIONS: This first Scandinavian real-world clinical trial with a new minimally invasive intragastric balloon system demonstrated good feasibility, but did not confirm expected efficacy for weight loss and diabetes control.

Fluid-filled intragastric balloons are an effective and safe weight loss option across BMI and age ranges.

INTRODUCTION: Obesity is an expanding public health problem, resulting in more than half a billion adults worldwide. Intragastric balloon (IGB) placement is a weight loss alternative for obese patients with an inadequate weight loss response to diet and exercise. The aim of this study is to examine the efficacy and safety of the single-chamber fluid-filled IGB for weight loss and compare its results across different age groups. METHODS: We performed a database review of 239 consecutive patients from two outpatient GI clinics who underwent placement of an IGB. Our final analysis composed of 239 IGB placements in 232 patients (mean age, 44.5 ± 10.3 years; 67% female; baseline BMI 42.0 ± 9.0). Efficacy outcomes included the percentage of the total (%TWL) and excess weight loss (%EWL). Safety outcomes were measured as the number of patients who required early IGB removal (before 6 months). RESULTS: %TWL at 3 months was 10.1% and 14.4% at 6 months. Overall, 92%, 74%, and 47% of patients lost 5%, 10%, and 15% of total weight at 6 months, respectively. %EWL was 22.1% and 30.7% at 3 and 6 months post-IGB placement, respectively. The balloon was safely removed at six months after placement in most patients, whereas in 13.0% of cases early removal was performed at an average of 12.0 weeks after placement (range, 2 days-23 weeks). CONCLUSION: The use of a single-chamber fluid-filled IGB is successful in inducing a significant amount of weight loss in almost three-fourths of patients six months after its placement. This beneficial effect is seen across different BMI ranges and age groups at a similar level. IGBs should be considered an effective and safe alternative for obese patients who fail lifestyle interventions and conservative measures, fulfilling the unmet needs of many who are unwilling or unable to undergo bariatric surgery.

Impact of preoperative weight loss achieved by gastric balloon on peri- and postoperative outcomes of bariatric surgery in super-obese patients: a retrospective matched-pair analysis.

BACKGROUND: An intragastric balloon is used to cause weight loss in super-obese patients (BMI > 60 kg/m2) prior to bariatric surgery. Whether weight loss from intragastric balloon influences that from bariatric surgery is poorly studied. METHODS: In this retrospective, single-center study, the effects of intragastric balloon in 26 patients (BMI 69.26 ± 6.81) on weight loss after bariatric surgery (primary endpoint), postoperative complications within 30 days, hospital readmission, operation time, and MTL30 (secondary endpoints) were evaluated. Fifty-two matched-pair patients without intragastric balloon prior to bariatric surgery were used as controls. RESULTS: Intragastric balloon resulted in a weight loss of 17.3 ± 14.1 kg (BMI 5.75 ± 4.66 kg/m2) with a nadir after 5 months. Surgical and postoperative outcomes including complications were comparable between both groups. Total weight loss was similar in both groups (29.0% vs. 32.2%, p = 0.362). Direct postoperative weight loss was more pronounced in the control group compared to the gastric balloon group (29.16 ± 7.53% vs 23.78 ± 9.89% after 1 year, p < 0.05 and 32.13 ± 10.5% vs 22.21 ± 10.9% after 2 years, p < 0.05), who experienced an earlier nadir and started to regain weight during the follow-up. CONCLUSION: A multi-stage therapeutic approach with gastric balloon prior to bariatric surgery in super-obese patients may be effective to facilitate safe surgery. However, with the gastric balloon, pre-treated patients experienced an attenuated postoperative weight loss with an earlier nadir and earlier body weight regain. This should be considered when choosing the appropriate therapeutic regime and managing patients' expectations.

Effects of intragastric balloon in patients with nonalcoholic fatty liver disease and advanced fibrosis.

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.

The Effect of Endoscopic Bariatric and Metabolic Therapies on Gastroesophageal Reflux Disease.

Obesity is a chronic disease that is becoming increasingly more prevalent and is associated with many health problems, such as metabolic syndrome. The treatment options for obese patients include lifestyle modification, medications, endoscopic bariatric and metabolic therapies (EBMTs), and surgery. In particular, EBMTs have an excellent therapeutic effect and are less invasive than bariatric surgery. Although it is clear that EBMTs are relatively safe procedures, they can result in several adverse events. Among them, the relationship between EBMTs and gastroesophageal reflux disease (GERD) is unclear. Several studies have demonstrated that an intragastric balloon (IGB) may worsen GERD. There are a few studies on the effects of endoscopic sleeve gastroplasty (ESG) on GERD, but the linking evidence is insufficient. However, the conclusion is not simple. Because obesity is an important cause of GERD, and GERD naturally improves with weight loss after EBMTs, it is not easy to evaluate accurately the effect of EBMTs on GERD. This review aimed to discuss the effect of EBMTs on GERD and suggest future research directions.

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.

Preoperative intragastric balloon in morbid obesity is unable to decrease early postoperative morbidity of bariatric surgery (sleeve gastrectomy and gastric bypass): a clinical assay.

INTRODUCTION: There are few studies that investigate the usefulness of the preoperative intragastric balloon (IGB). This study will evaluate if pre-surgical weight loss with IGB reduces morbidity and mortality after surgery. METHOD: Prospective randomised study of patients with morbid obesity treated with gastric bypass or vertical gastrectomy, with two arms: the balloon arm (B-arm), where an IGB was inserted within the 6 months before surgery, and the control arm (C-arm). RESULTS: The study included 66 patients: 65.6% women, 69.6% with bypass. Age: 43 years (SD 10.2) B-arm and 42.6 years (SD 9.2) in the C-arm. We found 34.4% therapeutic failures in IGB. The mean body weight loss, %EWL and BMI reduction before surgery was 16.2 kg (SD 9.84) B-arm versus 4.7 (SD 8.70) in the C-arm, 23.6% versus 4.7% (p < 0.001) and 6.04 versus 1 (p < 0.001), respectively. The hospital stay was 7 days (p25-75: 5-8) B-arm and 7 days (p25-75: 5-9) in the C-arm (p = 0.937). Post-surgical morbidity with IGB was 25% versus 29.5% in the C-arm, p = 0.689. The number needed to treat (NNT) to prevent of post-surgical morbidity was 23 patients. The B-arm presented 54.5% moderate-severe post-surgical adverse events (12.5%) versus 82.6% in the C-arm (23.5%), p = 0.111. The cost of placing a balloon was more than 4000 Euros each. CONCLUSIONS: The preoperative balloon does not achieve a reduction in the post-surgical morbidity, nor does it reduce the hospital stay or rate of re-operations. The balloon achieves a higher weight loss result when compared to a diet programme, its added cost must also be given due consideration. TRAIL REGISTRY: This study has been registered on ClinicalTrials.gov with the Identifier: NCT01998243 (November 28, 2013).

Metabolic Endoscopy: Development and Perspectives.

BACKGROUND: Obesity and its metabolic sequelae are among the most serious challenges faced by health systems today and they are expected to pose a serious threat in the future as well. Therapy ranges from lifestyle modification to drug treatment to surgery. Metabolic endoscopy (ME) might close the gap between invasive "metabolic" surgery and conservative, less effective treatment. In recent years, several endoscopic approaches have emerged, promising a safe and effective approach to cope with obesity. Data on metabolic endpoints is scarce. This article will therefore highlight procedures with data on type 2 diabetes mellitus (T2DM) as the most prominent component of the metabolic syndrome. SUMMARY: Most procedures showed beneficial effects in terms of weight reduction. For gastric procedures, there were no systematic studies primarily addressing parameters of glucose metabolism or diabetes outcomes. Metabolic benefit, if there is any, is most likely a by-product of weight loss. By contrast, duodenal-jejunal bypass sleeve (DJBS) is conceptually an antidiabetic procedure. Although adverse events are frequent, recent data points to a positive benefit-risk ratio. Key Messages: ME has the potential to constitute a growing field in the treatment of obesity and associated T2DM. While data published on glycaemic parameters in restrictive approaches is not sufficient, there is strong evidence that malabsorptive DJBS has an antidiabetic "plus" effect. Further studies are necessary to define the role of ME within a lifelong concept of treating obesity and T2DM.

Bridging interventions before bariatric surgery in patients with BMI ≥ 50 kg/m2: a systematic review and meta-analysis.

BACKGROUND: Bariatric surgery on patients with body mass index (BMI) ≥ 50 kg/m2, historically known as superobesity, is technically challenging and carries a higher risk of complications. Bridging interventions have been introduced for weight loss before bariatric surgery in this population. This systematic review and meta-analysis aims to assess the efficacy and safety of bridging interventions before bariatric surgery in patients with BMI ≥ 50 kg/m2. METHODS: MEDLINE, EMBASE, Web of Science, and Scopus were searched from database inception to September 2018. Studies were eligible for inclusion if they conducted any bridging intervention for weight loss in patients with BMI greater than 50 kg/m2 prior to bariatric surgery. Primary outcome was the change in BMI before and after bridging intervention. Secondary outcomes included comorbidity status after bridging interventions and resulting complications. Pooled mean differences (MD) were calculated using random effects meta-analysis. RESULTS: 13 studies including 550 patients met inclusion criteria (mean baseline BMI of 61.26 kg/m2). Bridging interventions included first-step laparoscopic sleeve gastrectomy (LSG), intragastric balloon (IGB), and liquid low-calorie diet program (LLCD). There was a reduction of BMI by 12.8 kg/m2 after a bridging intervention (MD 12.8, 95% CI 9.49-16.1, P < 0.0001). Specifically, LSG demonstrated a BMI reduction of 15.2 kg/m2 (95% CI 12.9-17.5, P < 0.0001) and preoperative LLCD by 9.8 kg/m2 (95% CI 9.82-15.4, P = 0.0006). IGB did not demonstrate significant weight loss prior to bariatric surgery. There was remission or improvement of type 2 diabetes, hypertension, and sleep apnea in 62.8%, 74.6%, and 74.6% of patients, respectively. CONCLUSIONS: First-step LSG and LLCD are both safe and appropriate bridging interventions which can allow for effective weight loss prior to bariatric surgery in patients with BMI greater than 50 kg/m2.

Impact of Weight Loss With Intragastric Balloon on Bone Density and Microstructure in Obese Adults.

The historical concept that obesity protects against bone fractures has been questioned. Weight loss appears to reduce bone mineral density (BMD); however, the results in young adults are inconsistent, and data on the effects of weight loss on bone microstructure are limited. This study aimed to evaluate the impact of weight loss using an intragastric balloon (IGB) on bone density and microstructure. Forty obese patients with metabolic syndrome (mean age 35.1 ± 7.3 yr) used an IGB continuously for 6 mo. Laboratory tests, areal BMD, and body composition measurements via dual-energy X-ray absorptiometry, and volumetric BMD and bone microstructure measurements via high-resolution peripheral quantitative computed tomography were conducted before IGB placement and after IGB removal. The mean weight loss was 11.5%. After 6 mo, there were significant increases in vitamin D and carboxyterminal telopeptide of type 1 collagen levels. After IGB use, areal BMD increased in the spine but decreased in the total femur and the 33% radius. Cortical BMD increased in the distal radius but tended to decrease in the distal tibia. The observed trabecular bone loss in the distal tibia contributed to the decline in the total volumetric BMD at this site. There was a negative correlation between the changes in leptin levels and the measures of trabecular quality in the tibia on high-resolutionperipheral quantitative computed tomography. Weight loss may negatively impact bone microstructure in young patients, especially for weight-bearing bones, in which obesity has a more prominent effect.

Design of the Weight-loss Endoscopy Trial (WET): a multi-center, randomized, controlled trial comparing weight loss in endoscopically implanted duodenal-jejunal bypass liners vs. intragastric balloons vs. a sham procedure.

BACKGROUND: Obesity is a global problem leading to reduced life expectancy, cardiovascular diseases, diabetes and many types of cancer. Even people willing to accept treatment only achieve a mean weight loss of about 5 kg using commercial weight loss programs. Surgical interventions, e.g. sleeve gastrectomy or gastric bypass are effective but accompanied by risk of serious complications and side effects. Less invasive endoscopic procedures mainly comprise the intragastric balloon (IB) and the duodenal-jejunal bypass liner (DJBL). To date, a randomized comparison between these devices has not been undertaken or shown to be superior to a sham procedure. METHODS: We designed a multi-center, randomized, patient and assessor-blinded, controlled trial comparing weight loss in endoscopically implanted IB vs. DJBL vs. a sham procedure. A total of 150 patients with a BMI > 35 kg/m2 or > 30 with obesity-related comorbidities and indication for proton pump inhibitors are randomized to receive either IB, DJBL or a sham gastroscopy (2:2:1 ratio). All participants undergo regular dietary consultation. The IB will be removed after 6 months, whereas the DJBL will be explanted after 12 months. All patients will receive gastroscopies at implantation and explantation of the devices or sedation without gastroscopy to maintain blinding. Main exclusion criteria are malignant diseases, peptic ulcer or previous bariatric intervention. Weight loss 12 months after explantation of the devices, changes in comorbidities, quality of life, complication rates and safety will be evaluated. DISCUSSION: This trial could help to identify the most effective and safest endoscopic device, thus determining the new standard procedure for endoscopic bariatric treatment. TRIAL REGISTRATION: 16th January 2017. DRKS00011036. Funded by the German Research Foundation (DFG).

Impact of 6 months of treatment with intragastric balloon on body fat and quality of life in obese individuals with metabolic syndrome.

BACKGROUND: Obesity is a worldwide public health issue with a negative impact on quality of life. Different weight loss interventions have demonstrated improvements in quality of life. The aim of this study was to investigate the effect of 6 months of treatment with an intragastric balloon (IGB) on health-related quality of life (HRQOL) and its relation to changes in body fat in obese individuals with metabolic syndrome (MS). METHODS: Fifty obese patients with MS aged 18-50 were selected for treatment with IGB for 6 months. Body fat was assessed with anthropometric measures and dual-energy X-ray absorptiometry (DXA) at baseline and after removal of the IGB. HRQOL was evaluated with the short form of the World Health Organization Quality of Life (WHOQOL-BREF) at baseline and soon after removal of the IGB. RESULTS: Thirty-nine patients completed the study. After 6 months, there was a significant improvement in quality of life (p = 0.0009) and health (p < 0.0001) perceptions, and in the Physical (p = 0.001), Psychological (p = 0.031), and Environmental domains (p = 0.0071). Anthropometric measures and total fat determined by DXA were directly and significantly related to an improvement in general aspects of quality of life. The decrease in the percentage of total fat was the parameter that better correlated with improvements in quality of life perception after regression (p = 0.032). CONCLUSIONS: In obese individuals with MS, weight loss parameters were associated with short-term improvements in HRQOL after 6 months of treatment with IGB. However, only total fat was independently related to HRQOL perception. TRIAL REGISTRATION: ClinicalTrials.gov NCT01598233 .

Filling the Void: A Review of Intragastric Balloons for Obesity.

Endoscopic bariatric therapies are predicted to become much more widely used in North America for obese patients who are not candidates for bariatric surgery. Of all the endoscopic bariatric therapies, intragastric balloons (IGBs) have the greatest amount of clinical experience and published data supporting their use. Three IGBs are FDA approved and are now commercially available in the USA (Orbera, ReShape Duo, and Obalon) with others likely soon to follow. They are generally indicated for patients whose BMI ranges from 30 to 40 mg/kg2 and who have failed to lose weight with diet and exercise. IGBs have been shown to be safe, effective, and relatively straightforward to place and remove. Accommodative symptoms commonly occur within the initial weeks post-placement; however, major complications are rare. Gastric ulceration can occur in up to 10% of patients, while balloon deflation with migration and bowel obstruction occurs in <1% of patients. The effectiveness of the Orbera and ReShape Duo IGBs ranges from 25 to 50% EWL (excess weight loss) after 6 months of therapy. The use of IGBs is likely to grow dramatically in the USA, and gastroenterologists and endoscopists should be familiar with their indications/contraindications, efficacy, placement/removal, and complications.