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Evaluation of an Endoscopic Sutured Gastroplasty in Patients With NonAlcoholic Steatohepatitis (NASH) and Fibrosis.

Erasme University Hospital · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver diseases characterized by liver steatosis which can, in a minority of patients, progress to nonalcoholic steatohepatitis (NASH), fibrosis, and ultimately hepatocellular carcinoma and liver failure. NASH is also recognized as an independent cardiovascular risk factor. Currently, weight loss is the only validated treatment for NASH and also positively affect all the features of metabolic syndrome. Considering the known positive metabolic effects of bariatric surgery, efforts have been exerted to develop minimally endoscopic procedures aiming to induce weight loss. Therefore, we would like to evaluate in patients with NASH disease and fibrosis, the impact of an endoscopic sutured gastroplasty (with Endomina® device) on: * Mainly liver histological endpoints but also, * Surrogate markers of hepatic inflammation and fibrosis and * Surrogate markers of insulin resistance as well as fasting lipid and glycemic profiles.
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