Pancreatitis aguda asociada a balón intragástrico: reporte de caso y revisión de la literatura

La obesidad es una patología de importancia a nivel mundial porque conlleva a una alta carga de mortalidad y morbilidad. El balón intragástrico representa una técnica no quirúrgica empleada cada vez con más frecuencia para lograr pérdida de peso. Si bien, este se considera un método seguro, se han reportado algunas complicaciones desde náuseas y vómitos, hasta eventos adversos graves, tales como perforación. La pancreatitis aguda constituye una complicación muy rara del balón intragástrico y se atribuye su efecto a la compresión directa que ejerce sobre el páncreas. Presentamos el caso de una paciente mujer de 21 años, quien después de 7 meses de colocación de balón intragástrico, cursó con dolor abdominal, náuseas y vómitos, asociados a elevación de enzimas pancreáticas. Se hizo diagnóstico de pancreatitis aguda y se corroboró compresión de la cola del páncreas mediante estudio tomográfico. Se decidió retiro del balón mediante endoscopía, cursando luego con evolución favorable.

Obesity is a pathology of importance worldwide because it leads to a high burden of mortality and morbidity. The intragastric balloon represents a non-surgical technique used more and more frequently to achieve weight loss. Although this is considered a safe method, some complications have been reported, from nausea and vomiting to serious adverse events, such as perforation. Acute pancreatitis is a very rare complication of the intragastric balloon, and its effect is attributed to the direct compression it exerts on the pancreas. We present the case of a 21-year-old female patient who, after 7 months of intragastric balloon placement, developed abdominal pain, nausea, and vomiting, associated with elevated pancreatic enzymes. A diagnosis of acute pancreatitis was made and compression of the tail of the pancreas was confirmed by tomographic study. It was decided to remove the balloon by endoscopy, which then progressed favorably.

Perforated gastric ulcer after unhealthy decisions in a patient with an intragastric balloon, a hangover you will regret.

BACKGROUND: Perforated gastric ulcers are life-threatening surgical emergencies that need early diagnosis and treatment to overcome severe complications. With the rise of obesity in recent years, intragastric balloons have arisen as a "safe" strategy; however, in medicine, no treatment is risk-free. Nausea, pain, vomiting, and more severe complications like perforation, ulceration, and death can occur. CASE PRESENTATION: We present the case of a 28-year-old man with obesity; treatment with an intragastric balloon was initiated with good results at the beginning of his treatment. However, he neglected his treatment over time and made unhealthy choices, leading to a severe complication. However, thanks to prompt surgical treatment, he made a full recovery. COMPLICATIONS: Gastric perforation following an intragastric balloon is a severe and potentially life-threatening complication that an experienced multidisciplinary team must treat promptly and, more importantly, prevent.

Swallowable Intragastric Balloon: First Consecutive Experience in Argentina.

Background: Swallowable balloons are innovative devices for the treatment of obesity. Endoscopy or anesthesia for implantation is not required. They are generally well tolerated and experience reports satisfactory results in relation to weight loss. The objective of this study was to analyze the first experience with the implementation of a swallowable balloon in Argentina. Methods: It is a descriptive retrospective observational study on the treatment of obesity in patients who underwent swallowable balloons in Argentina, admitted to one center, in a period time of 12 months with a follow-up of 6 months. Results: A total of n = 153 patients were recruited between June 2021 and May 2022, 78% were women and 22% men. The average age was 39 years. Average body mass index was 29.5 kg/m2. Balloon implantation was performed with complete swallowing by the patients in 19.4% of the cases, swallowing with operator assistance in 55.5%, and swallowing with stylet assistance in 25%. The adverse effects reported were abdominal pain (80%), nausea (60%), vomiting (38%), headache (36%), gastroesophageal reflux (29%), constipation (11%), and diarrhea (7%). No deaths were reported. A mean 4-month weight loss of 12% was reported. Conclusion: Swallowable balloon for the treatment of obesity is effective, safe, and well tolerated. Adverse effects are not severe.

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.

Effects of intragastric balloon placement in metabolic dysfunction-associated fatty liver disease: A systematic review and meta-analysis.

BACKGROUND: Metabolic dysfunction-associated fatty liver disease corresponds to a clinical entity that affects liver function triggered by the accumulation of fat in the liver and is linked with metabolic dysregulation. AIM: To evaluate the effects of the intragastric balloon (IGB) in patients with metabolic dysfunction-associated fatty liver disease through the assessment of liver enzymes, imaging and several metabolic markers. METHODS: A comprehensive search was done of multiple electronic databases (MEDLINE, EMBASE, LILACS, Cochrane and Google Scholar) and grey literature from their inception until February 2021. Inclusion criteria involved patients with a body mass index > 25 kg/m2 with evidence or previous diagnosis of hepatic steatosis. Outcomes analyzed before and after 6 mo of IGB removal were alanine aminotransferase (IU/L), gamma-glutamyltransferase (IU/L), glycated hemoglobin (%), triglycerides (mg/dL), systolic blood pressure (mmHg), homeostatic model assessment, abdominal circumference (cm), body mass index (kg/m2) and liver volume (cm3). RESULTS: Ten retrospective cohort studies evaluating a total of 508 patients were included. After 6 mo of IGB placement, this significantly reduced alanine aminotransferase [mean difference (MD): 10.2, 95% confidence interval (CI): 8.12-12.3], gamma-glutamyltransferase (MD: 9.41, 95%CI: 6.94-11.88), glycated hemoglobin (MD: 0.17%, 95%CI: 0.03-0.31), triglycerides (MD: 38.58, 95%CI: 26.65-50.51), systolic pressure (MD: 7.27, 95%CI: 4.79-9.76), homeostatic model assessment (MD: 2.23%, 95%CI: 1.41-3.04), abdominal circumference (MD: 12.12, 95%CI: 9.82-14.41) and body mass index (MD: 5.07, 95%CI: 4.21-5.94). CONCLUSION: IGB placement showed significant efficacy in improving alanine aminotransferase and gamma-glutamyltransferase levels in patients with metabolic dysfunction-associated fatty liver disease as well as improving metabolic markers related to disease progression.

Endoscopic Procedures for Weight Loss.

PURPOSE OF REVIEW: To provide updated evidence on the endoscopic procedures for weight loss and to bring personal insights on the future of endobariatrics. RECENT FINDINGS: Intragastric balloons promote significant improvement in histologic and radiologic aspects of non-alcoholic steatohepatitis; the endoscopic sleeve gastroplasty is effective up to 5 years and seems particularly beneficial to patients with BMI≤40kg/m2; distal POSE is a promising technique but still lacks adequate clinical data; aspiration therapy triggers remarkable weight loss, but data on weight trends after removal of the device are still lacking; the satiety-inducing device, the sleeveballoon, the gastric mucosal devitalization, and the endoscopic magnetic partial jejunal diversion are promising procedures still under study and refinements. Several therapeutic options are necessary during obesity's natural history. Therefore, endobariatrics should act in harmony with lifestyle interventions, diet modification, psychological treatment, pharmacotherapy, and bariatric surgery seeking the best outcome in the long term.

Adverse Events and Complications with Intragastric Balloons: a Narrative Review (with Video).

Intragastric balloon (IGB) is a minimally invasive and reversible therapy for weight loss with a good efficacy and safety profile. Introduced in the 1980s, IGBs have significantly evolved in the last couple of decades. They mechanically act by decreasing the volume of the stomach and its reservoir capacity, delaying gastric emptying, and increasing satiety leading to a subsequent weight loss. Despite the low rates of complications and mortality associated with IGBs, adverse events and complications still occur and can range from mild to fatal. This review aims to provide an update on the current scientific evidence in regard to complications and adverse effects of the use of the IGB and its treatment. This is the first comprehensive narrative review in the literature dedicated to this subject.

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.

Benefits of multidisciplinary team management of obese patients with intragastric balloon placement: an analysis of 159 cases at a single center.

BACKGROUND: Intragastric balloon placement is an ideal weight loss method for those unfit or unwilling to undergo surgery. It is not known if multidisciplinary team management helps these patients the way it does with those who enroll in bariatric surgery programs. OBJECTIVES: The primary objective was to assess the efficacy of intragastric balloon on weight loss after a 6-month follow-up and the secondary objective was to assess the impact of multidisciplinary team intervention (psychological consultation, nutritional follow-up, and regular physical activity) on weight loss in the study patients. SETTING: Referral military tertiary care center, Mexico. METHODS: Retrospective study of 159 patients treated with intragastric balloon between June 2011 and December 2016 in a single institution with aims of assessing its efficacy and the impact of regular exercise, supervised diet, and psychological consultation during the intervention. RESULTS: One hundred fifty-nine patients were enrolled. There were no drop-offs nor patients lost to follow-up. The mean initial weight was 92.6 ± 12.6 kg with a decrease to a mean of 80.7 ± 12.4 kg at 6 months with a mean reduction of 11.9 kg (P < .0001). The initial mean body mass index (BMI) of the population was 33.8 ± 2.8 kg/m2, which decreased to a mean of 29.5 ± 3.3 kg/m2 of BMI. The mean BMI units lost was 4.3 kg/m2 (P < .0001). A 50.8 ± 33.8% excess weight loss was observed (P < .0001), and a mean 12.6 ± 7.6% of total weight loss was found (P < .0001). Significant interventions on BMI at 6 months were psychological consultation associated with a mean BMI reduction of 6.0 ± 3.0 kg/m2 versus a mean BMI reduction of 4.1 ± 1.9 kg/m2 of those who did not (P < .0001) and physical activity with a mean BMI reduction of 4.8 ± 2.3 kg/m2 for those who did exercise versus a mean BMI reduction of 4.1 ± 2.0 kg/m2 for those who did not (P = .041). CONCLUSIONS: Intragastric balloon managed patients get additional benefit on weight loss with psychological follow-up and exercise during the intervention. Given the retrospective nature of the study, further studies are needed to definitive conclusions.

New technologies and advances in weight loss therapy. / Nuevas tecnologías y avances en terapias para la pérdida de peso.

Bariatric surgery is the most effective treatment for obesity and its comorbidities but there are barriers that prevent its general acceptance. The growing obesity epidemic has resulted in the need for the creation of new, less invasive treatments, with a wide margin of safety and effectiveness for conditioning weight loss, at least greater than that resulting from treatment based on diet and exercise. Emerging therapies include devices that are endoscopically placed and removed, classified as: space-occupying devices, restrictive or anatomic-remodeling procedures, endoluminal bypass, and duodenal mucosal resurfacing. Percutaneous techniques and less invasive surgeries are also included. In general, results have shown improvement in glucose metabolism in diabetic patients. With respect to weight loss, results do not surpass those of bariatric surgery, but are better than results with conservative treatment (diet and exercise) and have a low rate of adverse events. Clinical use of a new technique should be carried out within a multidisciplinary management program that includes nutritional, psychologic, physical activity, and medical support. It must be understood that novel therapies are not being created to substitute bariatric surgery, but rather to increase treatment options in the general population, with greater reach and impact. The aim of the present study was to provide an up-to-date literature review on emerging technologies for the treatment of obesity.

Efficacy of Intragastric Balloons for Weight Loss in Overweight and Obese Adults: a Systematic Review and Meta-analysis of Randomized Controlled Trials.

Intragastric balloons (IGB) are the most widely used endoscopic bariatric and metabolic therapies. We aimed to evaluate the efficacy of IGB in comparison with sham or lifestyle interventions for weight loss in overweight and obese patients. This systematic review and meta-analysis was performed following the PRISMA guidelines. Electronic searches were performed to identify randomized controlled trials, which compared IGB with sham or lifestyle intervention. Thirteen RCTs with 1523 patients were included. The difference in mean %EWL and %TWL at follow-up was 17.98%, and 4.40%, respectively, which was significantly higher in the IGB group. Similarly, the difference in mean AWL and BMIL was 6.12 kg, and 2.13 kg/m2, respectively. IGB therapy is more effective than lifestyle intervention alone for weight loss in overweight and obese adults.

Intragastric balloon placement in the treatment of overweight and obesity: Experience at a Mexican referral center. / Colocación de balón intragástrico en el tratamiento del sobrepeso y obesidad: experiencia de un centro de referencia en México.

INTRODUCTION AND AIM: Intragastric balloon therapy is a temporary, minimally invasive method for inducing weight loss. Any balloon with a volume of 400mL induces satiety and delayed gastric emptying. The aim of the present study was to demonstrate its safety and efficacy. MATERIALS AND METHODS: We analyzed the safety and effectiveness of balloon placement in relation to weight loss in 128patients. Subgroups were compared through the Student's t test, ANOVA test, and the chi-square test, depending on the type of variable and the number of groups evaluated. Statistical significance was set at a P≤.05 to evaluate weight loss. RESULTS: Mean weight loss after balloon therapy was 10.7kg, with only 2 cases of complications due to oral feeding intolerance. Mean length of time with the balloon was 8months. There were no complications after 6months, but no further weight loss either (P=.540). Final weight loss versus initial weight loss was significant (P=.000). There was greater weight loss in the group that attended the bimonthly control appointments than in the group that did not: 12.7kg vs. 7.26kg (P=.000). CONCLUSIONS: The rates of the adverse events of intolerance and complications were very low in our study, compared with results in the literature: 1.6% vs. 4.7% and 0% vs. 3%, respectively. Intragastric balloon placement had better results when the patients attended the control appointments. Intragastric balloon therapy is a safe and efficacious method for reducing weight in patients with overweight and obesity.

Antibiotics to Prevent Relapse of Adjustable Gastric Balloon Hyperinflation: Feasible for Balloon Maintenance?

The placement of an intragastric balloon (IGB) plays an increasingly important role in the treatment of obesity. The authors describe the cases of 2 female patients, 34 and 62 years old, who were submitted to the implantation of a Spatz3® IGB to treat obesity. Ten to fourteen weeks later, the patients presented complaints of epigastric pain, vomiting, and abdominal distension. A bulging of the upper abdominal wall was noticed upon physical examination. Upper gastrointestinal endoscopy confirmed the clinical suspicion of IGB hyperinflation. It was decided to remove the 500 mL of saline solution with methylene blue from inside the balloon. During the same procedure, the IGB was refilled with 500 mL of fresh saline solution, methylene blue, and empiric ß-lactam antibiotic. The extracted content of the hyperinflated IGB was sent for microbiological culturing and was found to be positive for Streptococcus viridans in one of the cases. In the other case, the culture examination was negative, and after 8 weeks, the patient presented again with hyperinflation of the IGB. It was then decided to substitute the IGB with another balloon; the procedure was uneventful. The content of the removed IGB was sent for microbiological testing, and colonization by Candida tropicaliswas confirmed. This is a rare but potentially serious complication of IGB placement. Randomized trials are needed to clarify the role of antibiotics and antifungals in primary and secondary prophylaxis against IGB hyperinflation.

A colocação de um balão intragástrico (BIG) desempenha um papel cada vez mais importante no tratamento da obesidade. Os autores descrevem os casos de duas doentes, com 34 e 62 anos de idade, que colocaram BIG Spatz3® para tratamento da obesidade. Dez a catorze semanas após as doentes apresentaram queixas de dor epigástrica, vómitos e distensão abdominal. Um abaulamento da parede abdominal superior era evidente no exame físico. A endoscopia digestiva alta confirmou a suspeita clínica de hiperinsuflação do BIG. Decidiu-se remover os 500 mL de solução salina com azul de metileno do balão. Durante o mesmo procedimento, o BIG foi preenchido com 500 mL de nova solução salina, azul de metileno e antibiótico ß-lactâmico empírico. O conteúdo extraído do BIG hiperinsuflado foi enviado para cultura microbiológica que foi positiva para Streptococcus viridans em um dos casos. No outro caso, o exame de cultura foi negativo e após oito semanas, a doente apresentou novamente hiperinsuflação do balão. Foi então decidido substituir o balão; o procedimento decorreu sem intercorrências. O conteúdo do BIG removido foi enviado para exames microbiológicos, tendo sido identificada colonização por Candida tropicalis. Esta é uma complicação rara, mas potencialmente grave, da colocação do BIG. Ensaios clínicos randomizados são necessários para esclarecer o papel dos antibióticos e antifúngicos na profilaxia primária e secundária contra a hiperinsuflação do BIG.

Intragastric balloon placement for the management of obesity: improving patient selection.

OBJECTIVE: Review and determination of ideal characteristics for the management of obesity by intragastric balloon, in Monterrey, Mexico. METHOD: Retrospective analysis of 152 patients, with overweight and obesity from January 2009 to December 2015, to whom an intragastric balloon was placed. Demography, weight loss, decrease in body mass index (BMI) and complications were analyzed. The objective was to determine the group of patients that will benefit the most after endoscopic intragastric balloon placement. RESULTS: A sample of 120 women and 32 men was analyzed. As expected, greater weight loss was observed in patients with BMI > 40 (n = 10, 6.57%, m = 26.29 ± 5.69; p = 0.001) and the lowest in patients with a BMI < 29.9 (n = 24, 15.78 %). Greater satisfaction was detected among patients with an average loss of 15.24 ± 2.75 kg (p < 0.001), and greater indifference among patients with greater losses. There is a tendency among women towards dissatisfaction. CONCLUSIONS: The greatest weight loss was observed among patients with a BMI > 40, although the highest satisfaction was observed among men with an average BMI of 32, which is why we recommend the procedure for these patients. We consider it to be an excellent bridge procedure for patients with BMI > 50.

OBJETIVO: Revisión y determinación de las características ideales para el manejo de la obesidad por medio de balón intragástrico, en Monterrey, México. MÉTODO: Análisis retrospectivo de 152 pacientes, con sobrepeso y obesidad, de enero de 2009 a diciembre de 2015, a quienes se colocó un balón intragástrico. Se analizaron la demografía, la pérdida de peso, la disminución del índice de masa corporal (IMC) y las complicaciones. El objetivo fue determinar el grupo de pacientes que mejores resultados obtendrán tras la colocación del dispositivo por endoscopia. RESULTADOS: Se obtuvo una muestra de 152 pacientes, 120 mujeres y 32 hombres. Como era de esperar, se observó la mayor pérdida de peso en los pacientes con IMC > 40 (n = 10, 6.57%, m = 26.29 ± 5.69; p = 0.001) y la menor en los pacientes con IMC < 29.9 (n = 24, 15.78%). Se detectó una mayor satisfacción en los pacientes con una pérdida promedio de 15.24 ± 2.75kg (p < 0.001), y mayor indiferencia en los pacientes con mayores pérdidas. Se observa una tendencia en las mujeres hacia la insatisfacción. CONCLUSIONES: La mayor pérdida de peso se observó en los pacientes de IMC > 40, aunque la mayor satisfacción se observó en los hombres con IMC promedio de 32, por lo que lo recomendamos para estos pacientes. Consideramos que es un excelente procedimiento puente para pacientes con IMC > 50.

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.

Modifying an Intragastric Balloon for the Treatment of Obesity: a Unique Approach.

INTRODUCTION: The use of intragastric balloons (IGB) for the treatment of obesity has been increasing significantly, with data confirming its effectiveness with low complication rates. Adjustable balloons are not widely available for use in all countries, including the USA. In this video, we demonstrate a unique technique in which a conventional nonadjustable balloon is modified to an adjustable balloon to improve weight loss. METHODS: A 35-year-old woman with a BMI of 36.1 kg/m2 (84.4 kg) who had failed prior medical therapy for obesity presented for IGB placement. After discussion with the patient, including risks and benefits, a conventional IGB modified to a novel adjustable IGB was placed. RESULTS: In this primary experience, we describe the use of a conventional IGB modified to an adjustable balloon. First, during balloon placement, an initial 500 ml of saline was instilled. At one-month follow-up, the patient only experienced 3.67%TBWL; thus, the balloon was adjusted with the addition of 160 ml of saline through the newly created modification catheter. At a 2-month follow-up, a second adjustment was performed with the addition of 180 ml, for a total of 840 ml. At 4 months, patient experienced 10% TBWL and decreased in BMI by 3.6 kg/m2. No adverse events were reported. CONCLUSION: The transformation of a nonadjustable balloon into an adjustable balloon is feasible and effective in weight loss. This technique may be an alternative in cases where adjustable balloon is not available. Further studies are warranted to confirm the safety and efficacy of this novel device.

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.

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.

Efficacy and safety of intragastric balloon in the treatment of obesity in adolescent females

BACKGROUND: The aims of this study are to evaluate the efficacy and safety of intragastric balloon (IB) to reduce the weight and body mass index (BMI) in severely obese adolescent females and to describe the changes in the liver enzymes and lipid and glucose metabolism biomarkers. METHODS: This study included 10 severely obese post-menarche adolescent females. We evaluated anthropometric data, lipid profile, glucose metabolism biomarkers, and liver enzymes before insertion and after removal of the IB. RESULTS: BMI and weight reduction were larger during the first month of intervention. Especially in the first week, there was a reduction of 1.74 ± 0.46 kg/m2(p= 0.004) and 6.46 ± 1.52 kg (p= 0,002), respectively. After 3 months, there wasan average BMI reduction of 4.29 ± 1.04 kg/m (p= 0.005) and weight reduction of 12.9 ± 3.08 kg (p= 0.004). From the initial moment to study conclusion, there was a statistically significant reduction in insulin levels (9.0 ± 2.8 U/mL; p=0.012) and in homeostatic model assessment-insulin resistance (2.0 ± 0.6;p= 0.009). Five patients reported, during the first week, epigastric pain; nausea and vomiting were observed in two patients. No adolescents presented dysphagia during IB use. CONCLUSION: IB use in adolescent females with severe obesity in association with a conservative multidisciplinary treatment had a positive impact in BMI reduction, with few adverse effects. There was also an improvement in insulin resistance.