Effects of Intragastric Balloon in Patients With Non-alcoholic Fatty Liver Disease and Advanced Fibrosis

Federico Salomone; Walter Currenti; Giovanni Magrì; Ivo Boškoski; Shira Zelber-Sagi; Fabio Galvano


Liver International. 2021;41(9):2112-2116. 

In This Article

Abstract and Introduction


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™ 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/m2 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.


Nonalcoholic fatty liver disease (NAFLD) is emerging as the most common liver disease globally due to the worldwide epidemic of obesity.[1] Beyond metabolic complications, a subset of obese patients with NAFLD, and especially those with nonalcoholic steatohepatitis (NASH), develop fibrosis, which can progress to cirrhosis and liver cancer, making NAFLD a leading cause of liver transplantation and thus a public health burden.[2] The recommended treatment to prevent the progression of NAFLD is a healthy lifestyle targeting a 7%–10% weight reduction.[3] A 10% weight reduction exerts beneficial effects on liver histology including fibrosis regression, but this has been evaluated only in a few studies.[4–6] Observational studies and clinical trials have shown beneficial effects of bariatric surgery in patients with NAFLD, although bariatric surgery is associated with short-term and long-term complications.[7]

In recent years, endoscopic bariatric and metabolic therapies (EBMT) have shown safety and effectiveness for the treatment of obesity.[8] Among the EBMT, the intragastric balloons (IGBs) have become popular because of their efficacy in inducing weight loss through increased satiety, with a high safety profile.[9] Observational studies have revealed beneficial effects of EBMT on the severity of liver steatosis as assessed by noninvasive parameters.[10] Recently, Bazerbachi et al have evaluated the effects of IGB placement in a clinical trial including 21 patients with NASH and early fibrosis showing an improvement of all histological features at the end of the 6-month follow-up.[11]

In this study, we retrospectively evaluated the impact of IGB placement in a cohort of obese patients with NAFLD and advanced liver fibrosis.