Endoscopic bariatric therapies for obesity: a review.

▪ Obesity is reaching pandemic proportions globally, with overweight or obesity affecting at least two-thirds of Australian adults. ▪ Bariatric surgery is an effective weight loss strategy but is constrained by high resource requirements and low patient acceptance. ▪ Multiple endoscopic bariatric therapies have matured, with well established and favourable safety and efficacy profiles in multiple randomised controlled trials (RCTs), and are best used within a multidisciplinary setting as an adjuvant to lifestyle intervention. ▪ Three types of intragastric balloon are currently in use in Australia offering average total weight loss ranging from 10% to 18%, with others available internationally. ▪ Endoscopic sleeve gastroplasty produces average total weight loss of 15-20% with low rates of severe complications, with RCT data anticipated in December 2021. ▪Bariatric and metabolic endoscopy is rapidly evolving, with many novel, promising therapies currently under investigation.

The Effect of the Intra-gastric Balloon on Gastric Emptying and the DeMeester Score.

BACKGROUND AND AIMS: The mechanism of weight loss with the intra-gastric balloon (IGB) is thought to be a decrease in gastric emptying (GE); however the evidence is conflicting. Nausea, abdominal pain, and gastroesophageal reflux disease (GERD) can cause intolerance resulting in early removal. This is demoralizing for the patient and costly for the healthcare system. The ability to predict which patients will have superior weight loss and tolerance is invaluable. We sought to investigate if the IGB induced weight loss by reducing GE and the effect of the IGB on the DeMeester score. METHODS: We retrospectively reviewed prospectively collected data for patients undergoing IGB placement at a single hospital. Manometry and pH studies were performed before and with the IGB in place. Weight was measured at baseline, at removal, and 6 months later. Adverse events leading to early removal were recorded. RESULTS: Twenty-four patients were evaluated. There was a statistically significant decrease in GE for solids with the IGB (117.92 ± 150.23 vs 281.48 ± 206.49 min; p = 0.0048), but not for liquids (54.44 ± 17.97 vs 56.08 ± 43.96 min; p = 0.7228). The lower esophageal sphincter (LES) pressure did not change significantly with placement of the IGB (17.76 ± 7.39 vs 14.74 ± 7.24 mmHg; p = 0.09). On multivariate analysis, increase in DeMeester score was associated with total body weight loss (p = 0.0125) and change in GE (p = 0.038) independently. CONCLUSION: The IGB delays GE for solids, but not for liquids, and increases the DeMeester score by a mechanism other than a loss of LES pressure.

Efficacy and Safety of Intragastric Balloon Placements in 1600 Case, an Experience from the Middle East.

BACKGROUND AND PURPOSE: Intragastric balloons are used as a treatment for obesity. Much of the data collected on balloons had been in the context of clinical trials in academic medical centers or as a bridge to bariatric surgery in obesity centers. The aim of this study was to investigate the efficacy and safety of balloon treatment in private practice. STUDY DESIGN: This is an interventional study. SUBJECTS: The study included 1600 patients. PLACE: The study was conducted at the ElKatib Hospital. METHOD: This was a retrospective analysis of 6-month weight loss data and balloon-related complications of patients referred to a private center for obesity treatment. ASSESSMENT: The assessment was carried out by obtaining full patients' history (personal history, present illness, and previous drug history and operations). Laboratory work was done in the form of CBC, blood sugar, and viral markers. Bioenterics Intragastric Balloon (BIB) silicone balloon was used, filled with saline plus methylene blue dye with a volume ranging from 400 to 700 ml. The gained measures were analyzed by using SPSS program, and paired t test and chi-square test were used to compare between groups. RESULTS: A total of 1600 patients were included (368 male (23%) and 1232 female (77%)) with mean age 34.1 ± 10.354, mean body weight 112.45 ± 26.24, and mean body mass index (BMI) 40.32 ± 8.17. There were 46 patients younger than 18 years and 12 patients older than 60 years. There were 109 patients with a BMI ranging from 25 to < 35 and 737 patients with a BMI ≥ 40 kg/m2. A total of 1567 patients who attended weight consultation had a mean weight loss 17.35 ± 11.07 from intragastric balloon implantation. Thirty-three patients from the total sample were not weighted after the removal of the balloon (dropped out). Percentage excess weight loss (% EWL) = 100% × (baseline absolute weight (AW)-last weight)/(baseline AW-initial body weight (IBW)) was found, and weight loss of more than 10% was considered significant. About 49.3% of patients showed significant weight loss > 10%, 24.7% of patients showed weight loss > 20%, while 26% of patients showed no significant weight loss < 10%. CONCLUSION: Intragastric balloons on their own, with an intensive lifestyle program and supportive consultations, resulted in safe and short-term substantial weight loss, and may fill the therapeutic gap between pharmacotherapy and surgery.

Bariatric and metabolic endoscopy in the handling of fatty liver disease. A new emerging approach?

BACKGROUND: non-alcoholic fatty liver disease (NAFLD) is the most frequent cause of chronic hepatopathy in our environment. However, the benefits of the bariatric endoscopy in this disease are barely documented. OBJECTIVES: to evaluate changes in NAFLD, via non-invasive methods in obese patients who underwent bariatric restrictive endoscopy. Weight, metabolic changes and the level of technical safety were also analyzed as secondary objectives. METHODS: thirty patients with NAFLD and obesity (mean BMI 38.22 ± 6.55 kg/m2) underwent bariatric restrictive endoscopy; this included 15 one-year intragastric balloons and 15 sutured gastroplasties (ESG-Apollo®). A non-invasive prospective analysis was performed via analytical (hepatic function, insulin-resistance and hepatic steatosis/fibrosis scores) and ultrasonographic parameters. In addition, anthropometric features and the evolution of the main obesity-related comorbidities were evaluated. The follow-up period was one year in all cases. RESULTS: thirty patients were included; 63% were female with a mean age of 46 ± 13.8 years. There was a decrease in FLI, HSI, NAFLD-Fibrosis Score, hepatic ultrasonographic steatosis, subcutaneous fat (p < 0.001), HOMA-IR, insulin and triglycerides (p < 0.05) after 12 months. An average EWL of 44.02% (16.34% TBWL) was obtained after one year, with EWL > 25% in 27/30 patients (TBWL > 10% in 25/30 patients) (p < 0.001). Obesity-related comorbidities were resolved in 17/30 (57%) of cases, 5/8 (62.5%) HTA, 5/12 (41.7%) DLP, 2/4 (50%) T2DM, 2/3 (66.7%) SOAS and 3/3 (100%) arthropathy. An improvement in HbA1c in the ESG-Apollo group (p = 0.017) was the only difference. One migrated and spontaneously expelled balloon was the only technical incidence. CONCLUSIONS: bariatric endoscopy could be proposed during short-term follow-up as an effective and safe alternative in patients with obesity and NAFLD. It stimulates weight loss and improves analytical and ultrasound parameters from hepatic fat, insulin-resistance and hypertriglyceridemia. It also improves associated major comorbidities.

The Safety and Efficacy of Procedureless Gastric Balloon: a Study Examining the Effect of Elipse Intragastric Balloon Safety, Short and Medium Term Effects on Weight Loss with 1-Year Follow-Up Post-removal.

INTRODUCTION: The Ellipse intragastric balloon (EIGB) is a new swallowable balloon that does not require endoscopy at insertion or removal. The aim of this study is to investigate the safety of EIGB and its efficiency in weight reduction even after 1 year of expulsion. METHOD: Prospective study on our initial experience with a consecutive group of patients who underwent the insertion of EIGB in the period between September 2016 and February 2017. The patients were followed up to assess pain, nausea, and vomiting after procedure. As well as, the time of balloon extraction, route of extraction, and weight loss. RESULTS: Total of 112 patients underwent EIGB placement. A 1-year follow-up was obtained on 85% of patients. Mean weight and BMI before the procedure 92.2 kg and 34.3 kg/m2, respectively. One patient had small bowel obstruction. Six patients did not tolerate EIGB and three patients had early deflation. Total weight loss % (TWL%) 10.7, 10.9, and 7.9% at 3, 6, and at date of last follow-up. When data were stratified according to BMI into two groups: group 1 (BMI 27.5-34.9) and group 2 (BMI 35-49), the TWL% for group 1 at 3 months, 6 months, and last day of follow-up are as follows: 10.2%, 10.6%, and 8.8%, while it was 11.5%, 11.2%, and 6.6% for group 2. CONCLUSION: EIGB are effective, safe, and feasible non-invasive method for weight loss.

Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss.

BACKGROUND: Obesity is a significant health problem and additional therapies are needed to improve obesity treatment. OBJECTIVE: Determine the efficacy and safety of a 6-month swallowable gas-filled intragastric balloon system for weight loss. SETTING: Fifteen academic and private practice centers in the United States. METHODS: This was a double-blind, randomized sham-controlled trial of the swallowable gas-filled intragastric balloon system plus lifestyle therapy compared with lifestyle therapy alone for weight loss at 6 months in participants aged 22 to 60 years with body mass index 30 to 40 kg/m2, across 15 sites in the United States. The following endpoints were included: difference in percent total weight loss in treatment group versus control group was >2.1%, and a responder rate of >35% in the treatment group. RESULTS: Three hundred eighty-seven patients swallowed at least 1 capsule. Of participants, 93.3% completed all 24 weeks of blinded study testing. Nonserious adverse events occurred in 91.1% of patients, but only .4% were severe. One bleeding ulcer and 1 balloon deflation occurred. In analysis of patients who completed treatment, the treatment and control groups achieved 7.1 ± 5.0% and 3.6 ± 5.1% total weight loss, respectively, and a mean difference of 3.5% (P = .0085). Total weight loss in treatment and control groups were 7.1 ± 5.3 and 3.6 ± 5.1 kg (P < .0001), and body mass index change in the treatment and control groups were 2.5 ± 1.8 and 1.3 ± 1.8 kg/m2 (P < .0001), respectively. The responder rate in the treatment group was 66.7% (P < .0001). Weight loss maintenance in the treatment group was 88.5% at 48 weeks. CONCLUSIONS: Treatment with lifestyle therapy and the 6-month swallowable gas-filled intragastric balloon system was safe and resulted in twice as much weight loss compared with a sham control, with high weight loss maintenance at 48 weeks.

Improving Weight Loss by Combination of Two Temporary Antiobesity Treatments.

BACKGROUND: It is generally accepted that the efficacy with an intragastric balloon decreases after the first 4 months of treatment. Aim of this study is to evaluate if the association of a very low-calorie ketogenic diet (VLCKD) can improve the results in terms of weight loss parameters and co-morbidities, as compared to usually prescribed low-calorie diet (LCD). METHODS: For the present study (January 2016-June 2017), 80 patients (20 M/60 F, mean age 37.8 ± 6.1 years; excess weight 56 ± 10 kg; mean BMI 37.2 ± 3.8 kg/m2) underwent Orbera positioning. After 4 months, they were randomized into two groups according to the type of treatment: group A (Bioenterics intragastric balloon - Orbera + VLCKD) (n = 40), and group B (Orbera + LCD) (n = 40). RESULTS: All patients completed the study with good adherence to diet therapy treatment allocation. After the 6-month treatment period, at time of Orbera removal, mean weight loss was 19 kg and 12 kg in groups A and B respectively (p < 0.05). Mean BMI was 28.9 ± 2.8 and 31.6 ± 3.1 kg/m2 (p < 0.05), and %EWL was 33.1 ± 3.3 and 21.1 ± 2.9 (p < 0.05) in groups A and B respectively. During the last 2 months in group A, the mean weight loss was 8 kg, while in Group B, the main weight loss was 3 kg (p < 0.001). The VLCKD treatment induced a more significant reduction of major comorbidities related to metabolic syndrome. CONCLUSIONS: This study clearly indicates the efficacy of the prescription of very low-calorie ketogenic diet improving the efficacy of intragastric balloon positioning.

Intragastric balloon outcomes in super-obesity: a 16-year city center hospital series.

BACKGROUND: Intragastric balloons represent an endoscopic therapy aimed at achieving weight loss by mechanical induction of satiety. Their exact role within the bariatric armamentarium remains uncertain. OBJECTIVE: Our study aimed to evaluate the use of intragastric balloon therapy alone and before definitive bariatric surgery over a 16-year period. SETTING: A large city academic bariatric center for super-obese patients. METHODS: Between January 2000 and February 2016, 207 patients underwent ORBERA intragastric balloon placement at esophagogastroduodenoscopy. Four surgeons performed the procedures, and data were entered prospectively into a dedicated bariatric database. Patients' weight loss data were measured through body mass index (BMI) and excess weight loss and recorded at each clinic review for up to 5 years (60 mo). Treatment arms included intragastric balloon alone with lifestyle therapy or intragastric balloon and definitive bariatric surgery: gastric banding, sleeve gastrectomy, or Roux-en-Y gastric bypass. An additional treatment arm of analysis included the overall results from intragastric balloon followed by stapled procedure. RESULTS: One hundred twenty-nine female and 78 male patients had a mean age of 44.5 (±11.3) years and a mean BMI of 57.3 (±9.7) kg/m2. Fifty-eight percent of patients suffered from type 2 diabetes. Time from initial or first balloon insertion to definitive surgical therapy ranged between 9 and 13 months. Seventy-six patients had intragastric balloon alone, and 131 had intragastric balloon followed by definitive procedure. At 60 months postoperatively the intragastric balloon alone with lifestyle changes demonstrated an excess weight loss of 9.04% and BMI drop of 3.8; intragastric balloon with gastric banding demonstrated an excess weight loss of 32.9% and BMI drop of 8.9. Intragastric balloon and definitive stapled procedure demonstrated a BMI drop of 17.6 and an excess weight loss of 52.8%. Overall, there were 3 deaths (1.4%), 2 within 10 days due to acute gastric perforation secondary to vomiting and 1 cardiac arrest at 4 weeks postoperatively. CONCLUSION: Intragastric balloons can offer effective weight loss in selected super-obese patients within a dedicated bariatric center offering multidisciplinary support. Balloon insertion alone offers only short-term weight loss; however, when combined with definitive bariatric surgical approaches, durable weight loss outcomes can be achieved. A strategy of early and continual vigilance for side effects and a low threshold for removal should be implemented. Surgeon and unit experience with intragastric balloons can contribute to "kick starting" successful weight loss as a bridge to definitive therapy in an established bariatric surgical pathway.

Regulating migration of esophageal stents - management using a Sengstaken-Blakemore tube: A case report and review of literature.

Stent migration, which causes issues in stent therapy for esophageal perforations, can counteract the therapeutic effects and lead to complications. Therefore, techniques to regulate stent migration are important and lead to effective stent therapy. Here, in these cases, we placed a removable fully covered self-expandable metallic stent (FSEMS) in a 52-year-old man with suture failure after surgery to treat Boerhaave syndrome, and in a 53-year-old man with a perforation in the lower esophagus due to acute esophageal necrosis. At the same time, we nasally inserted a Sengstaken-Blakemore tube (SBT), passing it through the stent lumen. By inflating a gastric balloon, the lower end of the stent was supported. When the stent migration was confirmed, the gastric balloon was lifted slightly toward the oral side to correct the stent migration. In this manner, the therapy was completed for these two patients. Using a FSEMS and SBT is a therapeutic method for correcting stent migration and regulating the complete migration of the stent into the stomach without the patient undergoing endoscopic rearrangement of the stent. It was effective for positioning a stent crossing the esophagogastric junction.

Evaluating the safety of intragastric balloon: An analysis of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program.

BACKGROUND: Laparoscopic bariatric surgery (LBS) is effective for severe obesity but is invasive and costly. Intragastric balloons (IGBs) are increasingly popular as an alternative to LBS with modest short-term weight loss. However, IGBs are associated with complications and a comparison of the safety of IGB to LBS is warranted. OBJECTIVES: The objective of this study was to compare the safety profile of IGB with LBS through analysis of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database. SETTING: The MBSAQIP collects data from 791 bariatric surgery centers in the United States and Canada. METHODS: A propensity-matched analysis was performed between IGB and LBS. Multivariable logistic regression analysis was performed to determine if IGBs were independently associated with adverse outcomes. RESULTS: A total of 145,408 patients were included, of which 144,627 (99.5%) underwent LBS and 781 (0.5%) underwent IGB therapy. With one-to-one propensity score matching, 684 pairs of IGB and LBS patients were selected. Multivariable logistic regression found that IGB (odds ratio 1.97, confidence interval 1.10-3.52, P = .023) was independently predictive of 30-day adverse outcomes. This was due to a significantly higher nonoperative reintervention rate in the IGB cohort (4.2% versus 1.0%, P < .001) from early balloon removal (2.8%). CONCLUSIONS: In this propensity-matched analysis, IGBs were associated with a higher adverse event rate than LBS, due to a 4-times higher nonoperative reintervention rate. The utility of IGB as a primary weight loss intervention should be reconsidered due to its poor safety profile compared with LBS.

Fluid-Filled Versus Gas-Filled Intragastric Balloons as Obesity Interventions: a Network Meta-analysis of Randomized Trials.

BACKGROUND: Four commercially available intragastric balloons have been used for the management of obesity and underwent randomized controlled trials (RCTs), and we aimed to compare them using a network meta-analysis approach. METHODS: Several databases were queried from inception to May 26, 2017, and we included RCTs enrolling patients treated with Orbera, Heliosphere, ReShape Duo, and Obalon compared with another balloon, sham, or open-label control group. Two investigators independently abstracted data. A random effects frequentist network meta-analysis and relative ranking of agents using surface under the cumulative ranking probabilities were performed. RESULTS: We included 15 trials at low risk of bias (only two were head-to-head). Compared to control groups, the two fluid-filled devices were associated with significant outcome (% total body weight loss) at 6 months: Orbera, 6.72% (95% CI, 5.55, 7.89) and ReShape Duo 4% (95% CI 2.69, 5.31). Only one of the two gas-filled devices was associated with significant outcome at 6 months: Obalon 3.3% (95% CI 2.30, 4.30), and not the second: Heliosphere 6.71% (95% CI - 0.82, 14.23). Fluid-filled devices had the highest likelihood of superiority in achieving the outcome at 6 months (96.8%) and at 12 months (96.6%). The quality of evidence was high for comparisons against control. CONCLUSIONS: Fluid-filled balloons are more likely to produce weight loss compared to gas-filled balloons or lifestyle intervention. However, they may be associated with a higher rate of intolerance and early removal. This information will aid clinicians in device selection and engaging patients in shared decision-making.

Safety and Efficacy of a New Swallowable Intragastric Balloon Not Needing Endoscopy: Early Italian Experience.

PURPOSE: The aim of this study was to evaluate the safety and efficacy of a new intragastric balloon (Elipse™ Balloon, Allurion Technologies, Natick, MA USA) not needing endoscopy. MATERIALS AND METHODS: The balloon was swallowed under fluoroscopy in 38 consecutive patients (F/M 28/10, mean age 46.4 ± 10.6 years, mean weight 109.7 ± 21.9 kg, and mean body mass index (BMI) 38.6 ± 6.7 kg/m2). After 4 months, the balloon spontaneously emptied and it was excreted through the digestive tract without upper endoscopy. RESULTS: There were no complications during balloon passage. After 16 weeks, the mean weight loss was 12.7 kg, mean percent excess weight loss was 26%, and mean BMI reduction was 4.2 kg/m2. Total body weight loss was 11.6%. There was a significant reduction in major co-morbidities related to metabolic syndrome: blood pressure (p < 0.02), waist circumference (p < 0.002), triglycerides (p < 0.0001), blood glucose (p < 0.001), and HOMA-IR index (p < 0.001). At the end of the treatment, 37 balloons were naturally excreted in the stool, and one balloon was endoscopically removed. CONCLUSIONS: The results of this study on 38 consecutive patients demonstrate that the Elipse™ Balloon is safe, effective, and very well accepted by patients.

Brazilian Intragastric Balloon Consensus Statement (BIBC): practical guidelines based on experience of over 40,000 cases.

BACKGROUND: Intragastric balloons (IGBs) are a minimally invasive option for obesity treatment, acting as a space-occupying device and leading to weight loss through increased satiety. This device has been growing in popularity owing to its safety profile and good weight loss results. However, there are no published guidelines that standardize the technical aspects of the procedure. OBJECTIVES: To create a practical guideline for intragastric balloon usage. SETTING: Private and Academic Settings, Brazil. METHODS: A consensus meeting was held in São Paulo, Brazil, in June 2016, bringing together 39 Brazilian endoscopists with extensive experience in IGBs from all regions of the country. Topics on patient selection, indications, contraindications, multidisciplinary follow-up, technique, and adverse events were discussed in the form of questions. After electronic voting, a consensus was defined when there was ≥70% agreement. Experts were also requested to provide data on their experience with IGBs. RESULTS: The selected experts discussed and reached a consensus on 76 questions, mainly concerning specific indications and contraindications for the procedure; technical details, such as patient preparation, minimum balloon-filling volume, techniques for implant and explant; patient follow-up and recommended medication for the adaptation period; and adverse event management. The overall Brazilian expert data encompassed 41,863 IGBs, with a mean percentage total weight loss of 18.4% ± 2.9%. The adverse event rate after the adaptation period was 2.5%, the most common being hyperinflation (.9%) and spontaneous deflation (.8%) of the device. The early removal rate due to intolerance was 2.2%. CONCLUSIONS: The present consensus represents practical recommendations for performing IGB procedures and reflects Brazil's significant experience with this device. The experience of over 40,000 cases shows that the device leads to satisfactory weight loss with a low rate of adverse events.

Response Rates with the Spatz3 Adjustable Balloon.

BACKGROUND: Intragastric balloons (IGBs) have demonstrated efficacy; however, the percent of "responders" (> 25% estimated weight loss (EWL) or > 10% total body weight loss (TBWL)-as suggested by FDA) have been less reported. The Spatz3 adjustable intragastric balloon (AIGB) extends implantation to 1 year, decreases balloon volume for intolerance, and increases volume for diminishing effect. AIM: The aim of this study is to determine the efficacy/responder rate of the Spatz3 AIGB. METHODS: Implantations of Spatz3 in 165 consecutive patients (pts) in 2 centers were retrospectively reviewed. Mean BMI is 35.7, mean weight (wt) 99.1 kg, and mean balloon volume 495 ml (400-600 ml). Balloon volume adjustments were offered for intolerance and for wt loss plateau. RESULTS: In total, 165 pts were implanted yielding mean wt loss of 16.3 kg, 16.4% TBWL, and 67.4% EWL. Response (> 25% EWL; 10% TBWL) was achieved in 146/165 (88.5%) of patients. Response rates differed for 136 pts with BMI < 40 (91.2%) and 29 pts with BMI > 40 (69%). Down adjustments in 20 patients (mean - 150 ml) allowed 16/20 (80%) to continue IGB therapy. Up adjustments in 64 patients (mean 5.4 months; mean + 260 ml) yielded additional mean wt loss of 5.7 kg. One gastric perforation (0.6%) occurred in a patient who experienced abdominal pain for 2 weeks. Five patients with small ulcers did not require balloon extraction. CONCLUSIONS: (1) Within the limitations of a retrospective review, the Spatz3 balloon appears to be an effective wt loss balloon with better response rates in BMI < 40. (2) Up adjustments yielded a mean 5.7 kg extra wt loss. (3) Down adjustments alleviated early intolerance in 80% of patients. (4) These two adjustment functions may be instrumental in yielding a responder rate of 88.5%.

Is Endoscopy Really Necessary for Placing Intragastric Balloons?

BACKGROUND: Gastric balloons for weight loss have historically been placed after a screening endoscopy. However, the utility and yield of these endoscopies has not been studied. Therefore, we wanted to evaluate the utility of screening endoscopy and to assess patients who had balloons placed without endoscopy. METHODS: Data was collected on two cohorts. Cohort 1 consisted of patients who had a screening endoscopy prior to or upon balloon placement. Cohort 2 consisted of patients who were followed after having a balloon placed under fluoroscopic guidance without endoscopy. Balloon intolerance and findings on removal endoscopy were assessed in both cohorts. RESULTS: In cohort 1 (n = 253), two patients had severe symptoms on history; balloon placement was contraindicated based on screening endoscopy findings. Eleven patients with a history of hiatal hernia and the presence of severe belching demonstrated an insignificant hiatal hernia on endoscopy. In cohort 2 (n = 50), all patients had an unremarkable history. Three previously asymptomatic patients had balloon intolerance and one was found to have a 4-cm hiatal hernia and oesophagitis upon balloon removal. Out of 194 patients, 25 were either intolerant to the balloon or had relevant findings on removal endoscopy. Findings on screening endoscopy did not correlate with balloon intolerance or findings on removal endoscopy. CONCLUSION: These results demonstrate that a careful history can identify patients who may have contraindications for balloon therapy and that balloons can be placed safely after taking a careful history without screening endoscopy. Screening endoscopy may not be useful in predicting balloon intolerance or potential complications.

[Efficacy and future of endoscopic bariatric surgery in the treatment of obesity and metabolic diseases].

The emerging endoscopic technologies are proved to be effective treatments for obesity in selected patients and to offer the potential advantages of reduced invasiveness, reversibility and repeatability. From the view of operation principle, endoscopic technologies can be classified as restrictive procedure, malabsorption procedure and endoscopic revision of gastric bypass. Restrictive procedures include intragastric balloon, aspiration therapy, endoscopic sleeve gastroplasty (ESG) and transoral gastroplasty. Intragastric balloon employs space occupying, volume restriction and satiety mechanisms, which is superior to drugs and lifestyle change, but shorter than sleeve and bypass surgery. Aspiration therapy is similar to standard percutaneous endoscopic gastrostomy, while there are no available data regarding the obesity and metabolic improvement. Compared with traditional bariatric surgery, ESG does not excise gastric tissue with less complications and without weight regain, but it can not be used as an independent operation still now. Transoral gastroplasty is rarely applied clinically whose efficacy and long-term complications need further studies. Malabsorption surgery includes endoscopic duodenojejunal bypass sleeve (EDJBS) and endoscopic gastroduodenojejunal bypass sleeve(EGDJBS). EDJBS may have the similar mechanism like bypass reducing the blood glucose. Even with obvious effect of weight loss, EDJBS has high morbidity of complications and requirements of the skilled operators. EGDJBS, which imitates bypass anatomy changes and belongs to the mixed operation, should be superior to the above procedures in reducing weight theoretically, but due to the lack of clinical data, its short-term and long-term efficacy still need further clinical observation. As compared to the complexity and risks associated with telescopic surgical revision, endoscopic suturing has been confirmed as less invasive and safer for stomal revisions, while its long-term efficacy of reducing weight and improvement of diabetes are not yet clear. Even if long-term efficacy of reducing weight and morbidity of complication in endoscopic bariatric surgery are still indefinite, and clinical trial researches of large sample and long-term follow-up are absent, with the development of endoscopic skill and the gradual clinical application, endoscopic bariatric surgery will provide a new option for the patients of obesity and metabolic diseases.

The Influence of the Orbera Intragastric Balloon Filling Volumes on Weight Loss, Tolerability, and Adverse Events: a Systematic Review and Meta-Analysis.

BACKGROUND: The Orbera intragastric balloon (IGB) has been approved by the US Food and Drug Administration for use in patients with a body mass index (BMI) between 30 and 40 kg/m2 and is in wide use worldwide as a primary and bridge obesity management tool. The balloon filling volume (BFV) ranges between 400 and 700 mL of saline. Our objective was to determine whether there is an association between BFV and clinically relevant endpoints, namely weight loss outcomes, balloon tolerability, and adverse events. METHODS: A systematic review of studies investigating the use of the Orbera IGB system for obesity treatment was performed. Data was examined using random effects modelling and meta-regression analyses. RESULTS: Forty-four studies (n = 5549 patients) reported BFV and % total body weight loss (TBWL) at 6 months. Pooled %TBWL at 6 months was 13.2% [95% CI 12.3-14.0]. A funnel plot demonstrated a low risk of publication bias. Meta-regression showed no statistically significant association between filling volume and %TBWL at 6 months (p = 0.268). Higher BFV was associated with lower rates of esophagitis (slope = -0.008, p < 0.001) and prosthesis migration (slope = -0.015, p < 0.001). There was no association between BFV and early removal (p = 0.1), gastroesophageal reflux symptom (p = 0.64), or ulcer rates (p = 0.09). CONCLUSIONS: No association was observed between Orbera IGB filling volume and weight loss outcomes. Higher volumes appear to be associated with lower migration and esophagitis rates; thus, a balloon filling volume of 600-650 mL is recommended.

Intragastric Balloon Device: Weight Loss and Satisfaction Degree.

BACKGROUND: An intragastric balloon is a non-surgical device enhancing a sensation of early satiety and reducing food intake. The aim of this study is to analyze the results in terms of weight loss and patient satisfaction undergoing intragastric balloon implantation. METHODS: Air-filled and water-filled devices were used. All patients were participated in strict follow-up programs. Weight, body mass index (BMI), total body weight loss (TWL), percentage of excess weight loss (EWL), and satisfaction degree were taken into account. RESULTS: Eighty-one patients completed a 6-month period with a device in place; 72 of them were then contacted for a follow-up at 12.3 ± 2.4 months post-removal. During treatment period, in 76 cases (93.8 %), a statistically significant reduction in weight was observed. A statistically meaningful linear correlation between a 3-month EWL (or TWL) and a 6-month EWL (or TWL) was found. At the end of endoscopic treatment, a significant link between baseline BMI and EWL >20 % was found. Sixty-three percent of the patients were not satisfied with the procedure, did not deem useful to change their diet, and refused to perform it again. CONCLUSIONS: In our study, at device removal and 1 year thereafter, a statistically significant reduction in weight was observed. Most of the patients were found to have a weight loss more than the cut-off of 20 %. The weight reached at the third month appears to be predictive of the effectiveness of endoscopic treatment. Data showed an overall dissatisfaction with procedure.

Dual Intragastric Balloon: Single Ambulatory Center Spanish Experience with 60 Patients in Endoscopic Weight Loss Management.

BACKGROUND: Many obese patients fail conventional medical management and decline bariatric surgery. Less invasive weight loss options such as intragastric balloons may provide an opportunity to reach this large number of untreated patients. The aim of this study was to investigate the safety and effectiveness of the Dual Intragastric Balloon (DIGB) in the treatment of obese patients, as well as the impact of degree of obesity, age, and gender. METHODS: The study was conducted at the Bariatric Endoscopy Unit of the Madrid Sanchinarro University Hospital. Sixty patients (11 men, 49 women) underwent endoscopic placement of a DIGB filled with a total of 900 cc of saline (450 cc in each balloon) for at least 6 months, along with regular counseling from a multidisciplinary team. Study outcomes included: change in body weight (TBWL), % of loss of initial body weight (%TBWL), % of excess body weight loss (%EWL), and adverse events. RESULTS: Initial BMI 38.8 kg/m(2) decreased 6.1 units, with mean TBWL, %TBWL, and %EWL of 16.6 kg, 15.4 %, and 47.1 %, respectively. We found no difference in %TBWL between grade of obesity, age or sex, but morbidly obese patients demonstrated greater TBWL, and women and less obese subjects obtained higher %EWL. The DIGB was generally well tolerated, with one early removal for patient intolerance, one early deflation without migration, and one gastric perforation. Fourteen patients had small, clinically insignificant ulcers or erosions noted at the time of removal. CONCLUSIONS: The present study shows that the DIGB was easy to use, resulted in significant weight loss, safe, and well tolerated.