The Obalon swallowable intragastric balloon in pediatric and adolescent morbid obesity

Abstract

Background and study aims Incidence of morbid obesity has grown dramatically in the last half century and this phenomenon affects with particular severity the pediatric population. Dietary restrictions and careful programs to improve lifestyle are often ineffective to manage this particular group of patients, due to poor compliance typical of the adolescence. The aim of this study was to evaluate the effectiveness of a new intragastric balloon for treatment of morbidly obese children. Patients and methods A new swallowable intragastric balloon (Obalon) has been used for the first time in 17 obese children in order to assess its safety and effectiveness in terms of reduction in excess weight. In 9 of 17 children a second balloon was placed 30 to 40 days after the first insertion. All devices were endoscopically removed after a mean time of 18 weeks. Results In the group of 16 patients who completed the study (1 patient still under treatment) mean weight decreased from 95.8 ± 18.4 Kg to 83.6 ± 27.1 (P < 0.05). Mean body mass index (BMI) decreased from 35.27± 5.89 (range 30.4 – 48) to 32.25 ± 7.1 (range 23.5 – 45.7) (P > 0.05); mean excess weight, calculated according to Cole’s curves for pediatric populations, decreased from 36.2 ± 15.9 to 29.4 ± 18.3 Kg (P = 0.14), with an %EWL of 20.1 ± 9.8 (range 2.3 – 35.1). Waist circumference decreased from 109 ± 12.3 cm to 99 ± 10.5 cm (P < 0.05). Conclusions Obalon can be administered easily without complications, inducing an appreciable weight loss with a statistically significant reduction in BMI and an improvement in associated comorbidities.

Treatment Options for Severe Obesity in the Pediatric Population: Current Limitations and Future Opportunities

“…The most common adverse effect was gastric pain/cramping and treatment was well tolerated. In a separate case series report from the same group, 17 children and adolescents ages 10 to 17 years old with severe obesity underwent treatment with the same air‐filled intragastric balloon (of note, 9 of 17 had a second balloon placed approximately 1 month later owing to lack of weight loss response) for 18 weeks . Mean BMI reduction was approximately 3 kg/m 2 or 9% from baseline.…”

Obesity and weight management: What can we do as gastroenterologists?

“…This device is a valuable option and can be easily administered to both child and adolescent patients with appreciable weight loss and almost no sudden or serious adverse events. 24 …”

Hidden dangers and updated labels on gastric balloons

“…7,16,17 Pancreatitis is an increasingly recognized complication of IGB insertion and generally occurs within 1-year post-IGB insertion. 18 It is unknown whether continuous pressure on the pancreas occurs from the outset or only once the balloon settles into T A B L E 1 Characteristics, safety, and efficacy of various intragastric balloons 1,2,5,[9][10][11]13,22,23…”