NCT04669470

Bariatric Endoscopy and NAFLD

Influence of Bariatric Endoscopy on Clinical Course of NAFLD

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Ostrava · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Find out how bariatric endocopy will influence clinical course of non alcoholic fatty liver disease.

Detailed description

The study will test and investigate the impact of bariatric endoscopy (various types of intragastric balloons, endoscopic sleeve gastroplasty, aspiration therapy) on components of the metabolic syndrome in obese patients, especially on influencing non-alcoholic steatosis and steatohepatitis and signs of liver fibrotization and weight reduction. The method consists in performing a mini-invasive endoscopic procedure and, as a result, in reduced food intake. Current state of knowledge: Based on data evaluated according to EBM (Evidence Based Medicine), it is an indisputable fact that bariatric methods have a demonstrable effect not only on improving the parameters and regression of many metabolic syndromes, but also improve the course of non-alcoholic fatty liver disease (NAFLD). It is this nosological unit that is becoming the dominant cause of liver disease in developed countries and has two subunits, where simple hepatic steatosis (NAFL) is considered a benign disease, while the second, where fat accumulation in the liver is associated with the inflammatory process called non-alcoholic steatohepatitis (NASH). ) has serious consequences for the liver with the development of fibrotization leading to cirrhosis with all its adverse effects. Recently, however, it has been shown that even simple steatosis is not as benign as it seemed, but carries an independent risk for the patient due to an increased incidence of cardiovascular diseases, oncological manifestations and a higher incidence of metabolic syndrome manifestations. Classical bariatric endoscopy carries a number of risks associated with the patient for the surgical procedure, however, we also have less invasive methods of gradually more and more developing endoscopy and dreams of associated bariatric procedures with many times lower risk for the patient.

Conditions

• Obesity
• NAFLD
• Liver Steatosis
• Liver Fibrosis

Interventions

Type	Name	Description
PROCEDURE	bariatric endoscopy, mainly intragastric baloons, plication of stomach too	bariatric endoscopy, mainly intragastric baloons, plication of stomach too

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2020-12-16
• Last updated: 2020-12-16

Locations

1 site across 1 country: Czechia