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| Name | Class |
|---|---|
| University Hospital Olomouc | OTHER |
| University Hospital Ostrava | OTHER |
| Palacky University | OTHER |
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Find out how bariatric endocopy will influence clinical course of non alcoholic fatty liver disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group with adjustable IGB | Active Comparator |
| |
| Group with nin-adjustable IGB | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bariatric endoscopy, mainly intragastric baloons, plication of stomach too | Procedure | bariatric endoscopy, mainly intragastric baloons, plication of stomach too |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of patients with NAFLD with degree of fibrosis of the liver amog patients undergoing bariatric endoscopy and determine influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis | Amount of patients with NAFLD with degree of fibrosis of the liver amog patients undergoing bariatric endoscopy and determine influence of bariatric endoscopy on clinical course of NAFLD and liver fibrosis | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of bariatric endoscopy on improvements of weight, antropometric, improvements in components of metabolic syndrome | Influence of bariatric endoscopy on improvements of weight, antropometric, improvements in components of metabolic syndrome | 24 months |
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Inclusion Criteria:
To be eligible for participation in this study, subjects must conform to the following inclusion criteria:
Exclusion Criteria:
Subjects meeting any of the following exclusionary criteria cannot be enrolled in the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adam Vasura | Contact | 420597374191 | obezita@fno.cz |
| Name | Affiliation | Role |
|---|---|---|
| Adam Vasura, MD | - Department of gastroenterology, hepatology and pancreatology, Internal clinic, University hospital Ostrava | Study Chair |
| Evzen Machytka | Department of gastroenterology, hepatology and pancreatology, Internal clinic, University hospital Ostrava |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of gastroenterology, hepatology and pancreatology | Recruiting | Ostrava | 70800 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30683512 | Background | Fakhry TK, Mhaskar R, Schwitalla T, Muradova E, Gonzalvo JP, Murr MM. Bariatric surgery improves nonalcoholic fatty liver disease: a contemporary systematic review and meta-analysis. Surg Obes Relat Dis. 2019 Mar;15(3):502-511. doi: 10.1016/j.soard.2018.12.002. Epub 2018 Dec 6. | |
| 21553304 | Background | Machytka E, Klvana P, Kornbluth A, Peikin S, Mathus-Vliegen LE, Gostout C, Lopez-Nava G, Shikora S, Brooks J. Adjustable intragastric balloons: a 12-month pilot trial in endoscopic weight loss management. Obes Surg. 2011 Oct;21(10):1499-507. doi: 10.1007/s11695-011-0424-z. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005234 | Fatty Liver |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Study Chair |
| 30122876 | Background | Leoni S, Tovoli F, Napoli L, Serio I, Ferri S, Bolondi L. Current guidelines for the management of non-alcoholic fatty liver disease: A systematic review with comparative analysis. World J Gastroenterol. 2018 Aug 14;24(30):3361-3373. doi: 10.3748/wjg.v24.i30.3361. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |