Abstract
BACKGROUND/AIMS: Metabolic dysfunction-associated steatotic liver disease/metabolic dysfunction-associated steatohepatitis (MASLD/MASH) with obesity significantly increases the risk of cirrhosis unless substantial weight loss is achieved. This prospective study evaluates the impact of adjustable intragastric balloon (aIGB) placement on metabolic and histological parameters of MASLD/MASH, highlighting its efficacy in achieving weight loss necessary for disease resolution. METHODS: Thirty-six patients (17 females; mean age: 39.8 years; mean body mass index: 35.4 kg/m(2)) underwent aIGB placement with endoscopic ultrasound-guided liver biopsy at baseline and six months post procedure (September 2020 to February 2023). Patients with inadequate biopsy or early balloon removal were excluded. Primary outcomes included changes in the non-alcoholic fatty liver disease Activity Score (NAS); secondary outcomes were weight loss, alanine transaminase (ALT), fibrosis regression, and adverse events (NCT04182646). RESULTS: At six months, the mean total body weight loss (TBWL) was 12.65% (95% confidence interval: 10.38-14.92), with ≥5% TBWL achieved in 88.9% of patients. Balloon volume adjustments were required in 25 patients (75%) to address weight-loss plateau or intolerance. ALT levels improved significantly (86.36 ± 27.14 vs. 38.53 ± 16.57; P < 0.001). NASs improved in 91.7% of patients (median [interquartile range]: 3 [3-4] to 1 [0-1.75]), and fibrosis improvement was observed in 55.56%. Upward balloon adjustments were associated with greater improvements in NAS (P < 0.001) and steatosis (P = 0.002). No serious adverse events were reported. CONCLUSION: aIGB effectively induces significant weight loss and improves metabolic and histological parameters in MASLD/MASH patients, with upward volume adjustments enhancing outcomes. The procedure demonstrated an excellent safety profile. CLINICAL TRIAL REGISTRATION: This study was registered under registration number NCT04182646.