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


In this retrospective analysis, we demonstrated that weight loss induced by a fluid-filled silicon-made 6-month IGB can improve metabolic and liver abnormalities in obese patients with NAFLD and clinically significant fibrosis as assessed by liver stiffness. In the absence of effective pharmacological treatments so far, weight loss induced by lifestyle change is still the gold standard of NAFLD treatment as suggested by EASL/EASO/EASD guidelines.[3] Non-randomized studies demonstrated a reduction in the level of fibrosis following lifestyle modification, most pronounced with a weight reduction of 10% or more of total body weight.[4,6] The European Society of Clinical Nutrition and Metabolism guidelines provide a strong recommendation for 7%-10% weight loss to improve steatosis and liver biochemistry and for >10% to improve fibrosis.[13] However, only a few patients can achieve such a weight loss, even under intensive lifestyle intervention,[4] and treatment of advanced fibrosis represents an unmet need in the management of patients with NAFLD.

IGBs are space-occupying devices that are inserted in the stomach by endoscopy or that can be swallowed. IGBs "allow" patients small volume meals and induce satiety through delayed gastric emptying. Thus, we suggest that IGB may be a helpful tool at least in the short term to enhance compliance to hypocaloric regimens of obese subjects that, under the dietitian's regular counselling, may start learning healthy eating during the period of IGB. Although there is not enough evidence to recommend IGB for maintenance of weight loss in the long term, a multicenter, prospective, randomized trial including 255 obese subjects randomized to Orbera™ + lifestyle modifications versus lifestyle modifications showed that not only the IGB group displayed higher total weight loss at 6 mo but interestingly the difference in weight loss between the 2 groups was maintained at 12 mo (6 mo after removal).[14]

Although for this retrospective analysis we showed only the effects of Orbera™ in patients having it for the whole 6-month period, we experienced a 10% early removal due to reflux symptoms resistant to IPP or intolerance (data not shown). One study showed the importance of the evaluation of gastric emptying before IGB placement to identify patients who are most likely to tolerate IGB treatment and thus to optimize treatment outcomes.[15] However, this kind of pathophysiological evaluation is not possible in most of GI unit. Thus, the selection of patients remains a main challenge before deciding on placement of IGB.

Fluid-filled IGBs are more effective in inducing weight loss compared to gas-filled balloons or lifestyle intervention alone.[16] However, they may be associated with a higher rate of intolerance and early removal due to nausea/vomiting and reflux symptoms present in more than a half of patients,[17] although in our experience, treatment with proton pump inhibitors and anti-emetics are effective in controlling these symptoms. Nonetheless, Orbera™ may be associated with severe adverse events. However, severe adverse events are rare, as shown in a meta-analysis including 3698 patients in which serious adverse events were observed only in less than 1% of the patients (bowel obstruction in 0.8% and gastric perforation in 0.1%).[18] These aspects should be part of a shared decision-making process among the healthcare staff (gastroenterologist, dietitian, and psychologist) and the patient.

Most studies on IGBs mainly focused on obesity and in adjunct reported changes in liver enzymes or liver steatosis, whereas two studies specifically addressed effects on liver histology. A small RCT by Lee et al reported a reduction of the NAFLD activity score after 6 mo from Orbera™ placement.[19] In addition, a prospective open-label study in patients with NASH and fibrosis showed improvement of all histological parameters at the time of the IGB removal.[11] In our retrospective analysis, we used liver stiffness, which is a well-established noninvasive fibrosis marker,[12] and FIB-4 whose reduction correlates with histological improvement in liver fibrosis in patients with NASH.[20]

Our study has several limitations. We already discussed the limitation of using non-invasive parameters of liver fibrosis, although with high accuracy in detecting clinically significant liver fibrosis. Another main limitation is the retrospective nature of the study and the lack of a control group which does not allow to establish firm conclusions. Nonetheless, we believe that our results may further promote interest in exploiting EBMT for the treatment of NAFLD with clinically significant fibrosis. Rigorous, well-designed randomized controlled trials are needed to identify the "position" of the different EBMT in the treatment algorithm for NAFLD patients with obesity.