PC1165: Safety and Efficacy of Endoscopically Placed Intragastric Balloon in Obese Adolescents – a Pilot Study

Background: The current approach for pediatric obesity management includes changes in lifestyle, diet, and physical activity. Consistent lifestyle changes are difficult to accomplish, and long-term results are frequently unsatisfactory, hence adolescents are increasingly undergoing surgical intervention. In our project, we studied the endoscopically placed intragastric balloon (IGB) in obese adolescents as a possible management for obesity. Our study aims to evaluate safety and tolerability of IGB in obese adolescents and if it can result in weight loss in this population.

Methods: We recruited patients who met our inclusion and exclusion criteria described in Table 1. The multidisciplinary team consisted of a pediatric gastroenterologist, endocrinologist, psychologist, and dietitian at the weight management clinic. Patients were evaluated at baseline, at 3 and 6 months after the insertion of the IGB, and at 9 and 12 months after the removal of the IGB. The dietitian reviewed the nutrition questionnaire and guided the diet modification accordingly. Subjects had psychology evaluation before and during the trial to support adherence.

Results: Five patients underwent endoscopic IGB placement, three were female with an average age (range) of 16 years (15-17) and an average BMI 45.5 (39.1-58.2) at recruitment. Nausea, mild abdominal discomfort and fullness were reported by 3/5 subjects. One patient withdrew from the study and the balloon was removed after 3 months and 11 days of placement due to the absence of sensation of satiety and lack of compliance with the dietary recommendations. Four of the five included patients showed a measurable drop in their BMI, on average of 8%, within the first 6 months while the IGB was inserted, and it was more prominent during the first 3 months of trial. The average weight loss within 3 months was 3.5 kg. The support factor was essential in the compliance with dietary and physical activity recommendations. After balloon removal most patients regained the weight except for one patient (youngest patient age 15 at time of balloon insertion) who had great social support and had lowest BMI at the time of study start (BMI 39.1 Kg/m2). The BMI drop was associated with improvement of their metabolic blood profile including decreased ALT, AST, insulin, HbA1c, and triglyceride, especially in the patient who had the lowest BMI at the time of recruitment as detailed in Table 2.

Conclusion: Our small pilot trial demonstrated that IGB is a safe and well tolerated intervention for the management of obesity in this population. It showed that the intervention was associated with improvement of their BMI and metabolic blood profile while the IGB was in place. A larger cohort study is needed to determine the best settings for successful IGB use in adolescents evaluating BMI, length of IGB insertion and adjunctive measures including physical activities monitoring.