Effects of intragastric balloon in patients with nonalcoholic fatty liver disease and advanced fibrosis

Background and aims Effective therapy for clinically significant fibrosis in nonalcoholic fatty liver disease (NAFLD) is an unmet need. Data on the effectiveness of endoscopic placement of intragastric balloon (IGB) in patients with NAFLD are limited. In this study, we evaluated the impact of IGB placement in NAFLD patients with advanced fibrosis.Methods We retrospectively assessed the effects of the Orbera (TM) fluid-filled IGB in a cohort of obese patients with liver stiffness >= 9.7 kPa (corresponding to F3-F4). Patients with endoscopic signs of portal hypertension were excluded. Changes in metabolic and liver parameters from baseline to follow-up (6 mo) were assessed.Results A total of 26 obese patients, aged 53 [44 - 62] years, with BMI 35.1 +/- 4.7 kg/m(2) were included. All patients achieved a significant body weight loss (106 +/- 19.7 vs. 92 +/- 18.3 kg, P < .001) and waist circumference reduction (116 +/- 13.3 vs. 104 +/- 13.4 kg, P < .001) at 6-month follow-up after IGB placement. Weight loss induced by IGB lowered blood glucose (140 [112; 169] vs. 118 [94; 144] mg/dl, P < .01), glycated hemoglobin (7.5 +/- 1.3 vs. 6.6 +/- 1.2%, P < .001), FIB-4 (3.2 +/- 0.7 vs. 2.7 +/- 0.8, P < .001), liver stiffness (13.3 +/- 3.2 vs. 11.3 +/- 2.8 kPa, P < .001) and controlled attenuation parameter (355 [298-400] vs. 296 [255-352] dB/m, P < .01). Gastroesophageal reflux symptoms were common, but no severe adverse event was observed.Conclusion Obese patients with advanced liver fibrosis, treated with 6-month IGB, can achieve regression of fibrosis as assessed by reduction of liver stiffness and FIB-4. Randomized controlled trials are needed to confirm these findings.