Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04669470
Status:
UNKNOWN
Last Update Posted:
2020-12-16
First Post:
2020-12-09
Brief Title:
Bariatric Endoscopy and NAFLD
Sponsor:
University of Ostrava
Organization:
University of Ostrava
Study Overview
Official Title:
Influence of Bariatric Endoscopy on Clinical Course of NAFLD
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None