Bariatric Endoscopy and NAFLD

Not Applicable

• Conditions: Liver Steatosis; Obesity; NAFLD; Liver Fibrosis
• Interventions: Procedure: bariatric endoscopy, mainly intragastric baloons, plication of stomach too

• Registration Number: NCT04669470
• Lead Sponsor: University of Ostrava

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.

Study Timeline

• Study Start: 2020-10-01
• Status Verified: 2020-11
• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2020-12-09
• Last Update Submitted: 2020-12-09
• Study First Posted: 2020-12-16
• Last Update Posted: 2020-12-16
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

To be eligible for participation in this study, subjects must conform to the following inclusion criteria:

1. Age between 21-64 years;
2. BMI >30 Kg/m2
3. Must be able to comply with all study requirements for the duration of the study as outlined in the protocol. This includes complying with the visit schedule as well as study specific procedures such as: clinical assessment , endoscopy, radiography, as well as laboratory investigations.
4. Must be able to understand and be willing to provide written informed consent.

Exclusion Criteria

• Subjects meeting any of the following exclusionary criteria cannot be enrolled in the study:

  1. Achalasia and any other esophageal motility disorders
  2. Heart diseases: unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity.
  3. Hypertension: uncontrolled hypertension during last 3 month
  4. Severe renal, hepatic, pulmonary disease or cancer;
  5. GIT stenosis or obstruction
  6. Pregnancy or breastfeeding
  7. Impending gastric surgery 60 days post intervention;
  8. Currently participating in other study
  9. Celiac disease
  10. History of bariatric surgery
  11. Chronic or recent acute pancreatitis
  12. Type 2 diabetes with insuline medication or type 1 diabetes
  13. Hematologic disease or disease with impairment of hemocoagulation
  14. Decompensated psychiatric disease
  15. Autoimmune disease with chronic glucocorticoid or imunosupressive medications
  16. Uncontroled disease of thyroid gland
  17. Excesive abuse of addictive substances such alcohol or other

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group with adjustable IGB	bariatric endoscopy, mainly intragastric baloons, plication of stomach too	-
Group with nin-adjustable IGB	bariatric endoscopy, mainly intragastric baloons, plication of stomach too	-

Primary Outcome Measures

Name	Time	Method
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	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

Secondary Outcome Measures

Name	Time	Method
Influence of bariatric endoscopy on improvements of weight, antropometric, improvements in components of metabolic syndrome	24 months	Influence of bariatric endoscopy on improvements of weight, antropometric, improvements in components of metabolic syndrome

Trial Locations

Locations (1)

Department of gastroenterology, hepatology and pancreatology; 🇨🇿 Ostrava, Czechia