Roux-en-Y gastric bypass pouch outlet reduction using argon plasma coagulation to treat weight regain: a randomized controlled trial with a sham control group.

Background and study aims A comparative study was conducted to evaluate the efficacy of argon plasma coagulation (APC) therapy in treating post Roux-en-Y gastric bypass (RYGB) weight regain and the incidence of complications related to this procedure, using a sham treatment group as a control. Patients and methods Forty-one patients with a minimum weight regain of 10 kg and a minimum postoperative time of 36 months were randomized into two groups. Results In the APC group (n = 21), the mean initial weight was 100.4 kg and the mean weight regain was 24.94 kg. In the sham group (n = 20), the mean initial weight was 103.65 kg, and the mean weight regain was 25.18 kg. Anastomotic stenosis occurred only after the first APC session. The results for the comparison of APC with the sham group showed a percentage weight regain loss of 63.95 compared to -.65, and weight loss of 15.02 and -0.57), percentage total weight loss of 14.46 and -0.62, excess weight loss of 54.32 % and -2.34 %), and BMI reduction of 5.38 and -0.21, with P  < 0.0001 for all the comparisons. In the APC group, there was a significant reduction in HbA1c (5.66 % to 4.96 %) and triglycerides (153.20 mg/dL to 132.20 mg/dL). Conclusions This study indicates that APC outlet pouch reduction outperforms sham treatment in terms of weight loss for patients presenting weight regain after RYGB.

Randomized Prospective Clinical Study of Spatz3® Adjustable Intragastric Balloon Treatment with a Control Group: a Large-Scale Brazilian Experiment.

BACKGROUND: To analyze the results regarding weight loss and complications related to the Spatz3® adjustable intragastric balloon (IGB) in Brazil. METHODS: This randomized prospective study covered patients who had undergone treatment using a Spatz3® adjustable IGB between October 2016 and June 2018 at a private clinic in Rio de Janeiro, Brazil. The patients had a minimum body mass index (BMI) of 27 kg/m2. The study examined complications of Spatz3® treatment and BMI reduction, percentage of total weight loss (%TWL), and % of excess weight loss (%EWL). RESULTS: One hundred eighty patients underwent a Spatz3® balloon implant in the period. The patients were randomly divided into one group in which the Spatz balloon was kept at the same volume (600 mL) throughout treatment (Control Group), and another adjustment group with 250 mL greater volume. The complication rate was 16.14%. No death or major complication occurred during the study. Mean BMI decreased from 39.51 to 32.84 kg/m2 (p < 0.0001), bodyweight from 111.87 to 90.28 kg (p < 0.0001), and excess weight from 41.55 to 22.99 kg (p < 0.0001). The adjustment resulted in greater mean weight loss of 4.35 kg (- 8 to 17.6 kg), and the average time of the procedure was 7.12 ± 1.63 months. The upward adjustment group did not present greater %TWL, %EWL, or BMI reduction when compared with the control group (p = 0.4413, p = 0,9245, p = 0.2729, respectively). CONCLUSION: This study shows that Spatz3® IGB treatment is an effective procedure for weight reduction, with no mortality but higher morbidity compared with traditional IGBs. This procedure also enabled the balloon to stay in place for longer. The efficacy of upward adjustment still requires further confirmation.

Intragastric Balloon: a Retrospective Evaluation of 5874 Patients on Tolerance, Complications, and Efficacy in Different Degrees of Overweight.

BACKGROUND: Endoscopic methods, especially the intragastric balloon (IGB), have been shown to be effective for the treatment of excess weight. This study aimed to assess the tolerance, complications, and efficacy of excess weight treatment with a non-adjustable IGB during 6 months. METHODS: A total of 5874 patients treated with a liquid-filled IGB (600-700 mL) and followed up by a multidisciplinary team were evaluated. Participants presented an initial body mass index (BMI) ≥ 25 kg/m2 and were stratified according to sex and degree of overweight (overweight and obesity grades I, II, and III). RESULTS: The incidence of complications was 7.32% (n = 430): 6.10% (n = 357) early IGB removal, 0.20% (n = 12) gas production inside the balloon, 0.54% (n = 32) leakage, 0.32% (n = 19) pregnancy, 0.07% (n = 4) gastric perforation, 0.05% (n = 3) upper digestive bleeding, 0.01% (n = 1) Wernicke-Korsakoff syndrome due to excessive vomiting, and 0.02% each (n = 1) pancreatitis and esophagus perforation. The 5444 remaining patients (4081 women, 38 ± 38 years) presented a weight loss of 19.13 ± 8.86 kg and a BMI decreased significantly (p < 0.0001) (36.94 ± 5.67 vs. 30.08 ± 5.06 kg/m2). The % total weight loss (%TWL) was 18.42 ± 7.25%, and the % excess weight loss (%EWL) was 65.66 ± 36.24%. The treatment success rate (%TWL ≥ 10%) was 85%. The %EWL was higher in the pre-obese group (122.19%), followed by obesity grades I (76.67%), II (56.01%), and III (45.45%), with p < 0.0001 for each group. %EWL was higher in women (69.71%) than in men (53.39), with p < 0.0001 for each group. There was also a statistical difference between the TWL and EWL groups, with p < 0.001 for all analyses. CONCLUSION: Endoscopic IGB treatment for excess weight is an excellent therapeutic option for patients with different degrees of overweight.

Endoscopic full-thickness suturing plus argon plasma mucosal coagulation versus argon plasma mucosal coagulation alone for weight regain after gastric bypass: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Endoscopic transoral outlet reduction (TORe) has been used to manage weight regain after Roux-en-Y gastric bypass. We conducted a meta-analysis to summarize the efficacy and safety of the two most commonly used techniques: full-thickness suturing plus argon plasma mucosal coagulation (ft-TORe) and argon plasma mucosal coagulation alone (APMC-TORe). METHODS: A literature search of publication databases was performed from their inception to February 2020 for relevant studies. The outcomes of interest were percentage total body weight loss, gastrojejunal anastomosis (GJA) diameter, and adverse events (AEs). The pooled effect estimates were analyzed using a random-effects model. Meta-regression was conducted to identify associations between GJA diameter and weight loss. RESULTS: Nine ft-TORe (n = 737) and 7 APMC-TORe (n = 888) studies were included. APMC-TORe was performed as a series of sessions (mean number of sessions ranging from 1.2 to 3), whereas ft-TORe was mostly performed as a single session. Percentage total body weight loss was 8.0% (95% confidence interval [CI], 6.3%-9.7%), 9.5% (95% CI, 8.1%-11.0%), and 5.8% (95% CI, 4.3%-7.1%) after ft-TORe and 9.0% (95% CI, 4.1%-13.9%), 10.2% (95% CI, 8.4%-12.1%), and 9.5% (95% CI, 5.7%-13.2%) after APMC-TORe at 3, 6, and 12 months, respectively, with no weight-loss difference at 3 and 6 months (P > .05). Only one severe AE was observed after APMC-TORe and none after ft-TORe. Stricture formation was the most common AE (ft-TORe 3.3% and APMC-TORe 4.8%, P = .38). All were successfully treated by endoscopic dilation or conservative treatment. Smaller aperture of the post-TORe GJA and greater change in the GJA diameter correlated with greater weight loss in APMC-TORe and numerical trends in ft-TORe. CONCLUSIONS: This meta-analysis demonstrates that both ft-TORe and APMC-TORe offer significant and comparable weight-loss outcomes with a high and comparable safety profile. However, APMC-TORe typically required multiple endoscopic sessions. Identifying a goal for the final and change in GJA diameter could be useful treatment targets.

Endoscopic sleeve gastroplasty in the management of overweight and obesity: an international multicenter study.

BACKGROUND AND AIMS: Obesity is a pandemic affecting approximately 700 million adults worldwide, with an additional 2 billion overweight. Endoscopic sleeve gastroplasty (ESG) is a minimally invasive endoscopic bariatric therapy that involves remodeling of the greater curvature in an effort to reduce gastric capacity and delay gastric emptying. A variety of ESG suture patterns has been reported. This study is the first to use a uniform "U" stitch pattern across all centers to simplify technical aspects of the procedure and limit cost. This also uniquely assessed outcomes in all body mass index (BMI) categories and changes in metabolic rate, lean body mass, and adipose tissue composition. METHODS: This is a multicenter analysis of prospectively collected data from 7 centers including patients with overweight and obesity who underwent ESG. Primary outcomes included absolute weight loss, percent total body weight loss (%TWL), change in BMI, and percent excess weight loss (%EWL) at 6 and 12 months in overweight and obese classes I, II, and III. Secondary outcomes included adipose tissue, lean body mass reduction, and metabolic rate analyzed by bioimpedance. Additionally, immediate or delayed adverse events (AEs) were analyzed. Clinical success was defined as achieving ≥25% EWL at 1 year with ≤5% serious AE (SAE) rate following the American Society for Gastrointestinal Endoscopy (ASGE)/American Society for Metabolic and Bariatric Surgery (ASMBS) threshold. RESULTS: A total of 193 patients underwent ESG during the study period. All groups had >10% TWL and >25% EWL at 6 months of follow-up. On average, %TWL was 14.25% ± 5.26% and 15.06% ± 5.22% and the %EWL 56.15% ± 22.93% and 59.41% ± 25.69% at 6 months and 1 year of follow-up, respectively. %TWL was 8.91% ± .3%, 13.92% ± 5.76%, 16.22% ± 7.69%, and 19.01% ± .95% and %EWL 56.21% ± 2.0%, 62.03% ± 27.63%, 54.13% ± 23.46%, and 46.78% ± 2.43% for overweight and obesity classes I, II, and III, respectively, at 1 year. Male sex, age <41 years, and higher BMI were predictors of achieving a TWL ≥10% at 1-year follow-up. There was a significant reduction in adipose tissue from baseline. SAEs occurred in 1.03%, including 2 perigastric collections needing surgery. CONCLUSIONS: ESG appears to be feasible, safe, and effective in the treatment of patients with overweight and obesity according to ASGE/ASMBS thresholds.

Impact of Intragastric Balloon Treatment on Adipokines, Cytokines, and Metabolic Profile in Obese Individuals.

BACKGROUND: Obesity is accompanied by adipose tissue remodeling characterized by increased production of tumor necrosis factor-alpha (TNF-α), interleukin (IL)-6, leptin and resistin and reduced secretion of adiponectin, which favors inflammation, metabolic disorders, and cardiovascular diseases. Although intragastric balloon (IGB) can be considered safe and effective for weight loss, its effect on serum levels of these biomarkers has been evaluated only in a few studies, while no previous study evaluated its effect on circulating levels of resistin, TNF-α, and IL-6. The aim of this study was to evaluate the changes in serum levels of metabolic and inflammatory biomarkers in obese patients submitted to IGB treatment. METHODS: A prospective observational study involving 42 patients with obesity using IGB for 6 months. The patients were evaluated, on the day of insertion and withdrawal or adjustment of IGB, for the following: anthropometric measures and serum levels of adiponectin, leptin, resistin, TNF-α, IL-6, high-sensitivity C-reactive protein (hs-CRP), glucose, insulin, uric acid, triglycerides, and total cholesterol and fractions. RESULTS: The body mass index decreased from 35.15 ± 0.41 to 29.50 ± 0.54 kg/m2. There was a reduction (p < 0.05) in leptin, hs-CRP, glucose, insulin, HOMA-IR, and triglycerides, while the adiponectin/leptin ratio increased (p < 0.05). Moreover, weight loss presented (1) a positive association with the decrease in leptin, hs-CRP, glucose, insulin, HOMA-IR, uric acid, and total cholesterol and (2) a negative association with the reduction in adiponectin/leptin ratio. CONCLUSIONS: The present study suggests that 6 months of IGB treatment in obese individuals reduce serum leptin and hs-CRP and improves insulin resistance and lipid profile which may decrease cardiovascular risk.

Changes in Body Adiposity, Dietary Intake, Physical Activity and Quality of Life of Obese Individuals Submitted to Intragastric Balloon Therapy for 6 Months.

BACKGROUND: Obesity is an important risk factor for several chronic diseases and also is associated with worse quality of life. Intragastric balloon (IGB) is an effective method for weight loss. Although changes in lifestyle are critical to weight loss during and after IGB therapy, only a few studies evaluated dietary intake and none evaluated changes in physical activity with a validated questionnaire during the treatment. The aim of this study was to evaluate changes in total and central body adiposity, dietary intake, physical activity, and quality of life of patients with obesity submitted to IGB treatment for 6 months. METHODS: Prospective observational study involving 42 patients with obesity using IGB for 6 months. The patients were evaluated, on the day of insertion and withdrawal or adjustment of IGB for total and central body adiposity (anthropometry and bioelectrical impedance), dietary intake, physical activity (Baecke questionnaire), and quality of life (SF-36 questionnaire). RESULTS: There was a significant decrease in total and central body adiposity. The mean % total weight loss and % excess weight loss were 15.88 ± 1.42 and 56.04 ± 4.90, respectively and waist circumference decreased 13.33 ± 1.39 cm. There was a reduction in energy intake, an increase in physical activity, and an improvement of quality of life during IGB treatment. CONCLUSION: The present study suggests that IGB treatment during 6 months in individuals with obesity is effective for decreasing total and central body adiposity being associated with reduction in energy intake, increase in physical activity, and improvement in quality of life.

Exclusively endoscopic approach to treating gastric perforation caused by an intragastric balloon: case series and literature review.

Background and study aims Obesity is a serious disease, resulting in significant morbidity and mortality. Intragastric balloons (IGBs) have been in use since the 1980s. After the insertion of an IGB, complications such as migration of the device and even severe gastric perforation can occur, requiring laparoscopic surgery. Here, we report three cases of gastric perforation after IGB insertion. In all three cases, the perforation was successfully repaired through an exclusively endoscopic approach.

Efficacy of Intragastric Balloon Treatment for Adolescent Obesity.

BACKGROUND: Several studies conducted in adults suggest that intragastric balloon (IGB) is an effective and safe method for weight loss. Although the prevalence of obesity in adolescents has increased in recent years, the outcomes of IGB treatment in this age group are not known. The aim of this study was to evaluate the safety and efficacy of IGB treatment for weight loss in adolescents followed up for 6 months. METHODS: This is a retrospective longitudinal study including 27 adolescents (14-19 years; 23 female). All participants were referred to IGB treatment by their attending physician, presented body mass index (BMI) ≥ 29 kg/m2 (>p97 BMI/age index) and failed to lose weight in clinical treatments. A liquid-filled nonadjustable IGB with a volume of 600 to 700 ml was used for 6 months. All patients were included in a multidisciplinary program, and adherence to this program was evaluated as the number of attended appointments. RESULTS: There were no serious complications or deaths. The BMI decreased from 37.04 to 31.18 kg/m2 (p < 0.0001), body weight decreased from 102.21 to 86.23 kg (p < 0.0001), and excess weight diminished from 35.18 to 19.12 kg (p < 0.0001). The % excess weight loss (%EWL) was 56.19 and % total weight loss (%TWL) 16.35. Adherence to the multidisciplinary program correlated directly with %EWL (r = 0.55; p = 0.0033) and %TWL (r = 0.53; p = 0.0052). CONCLUSION: Endoscopic treatment of obesity with an IGB is safe, effective, and may be an emerging therapeutic option for adolescents.