Effectiveness of Endoscopic Sleeve Gastroplasty in Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis

Study Overview
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Brief Summary
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Endoscopic weight loss procedures, also termed endoscopic sleeve gastroplasty (ESG), has been proposed as a non-surgical procedure for managing obesity and offers a standard weight loss approach. Realizing there is a knowledge gap in applying ESG to morbidly obese patients with NAFLD, the investigators propose studying the efficacy of weight control and functional outcomes of ESG. This prospective pilot study is aimed to study the safety profiles, quality of life, and changes and improvements in the anthropometric, metabolic, and biochemical changes in these patients.

Official Title
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Effectiveness of Endoscopic Sleeve Gastroplasty in Obese Patients With Nonalcoholic Fatty Liver Disease

Conditions
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Nonalcoholic Fatty Liver Disease

Intervention / Treatment
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* Procedure: Endoscopic Sleeve Gastroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) greater than 30 kg/m2, who are eligible for ESG Patients scheduled to undergo an endoscopic bariatric weight loss procedure (ESG) Patients older than 18 years and younger than 75 years of age at the time of consent Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form Patients willing and able to comply with study requirements for follow-up Exclusion criteria: Patients who are treated with intragastric balloons Family history of esophageal, gastric, or duodenal malignancy and active gastric ulceration, Pre-existing esophageal stenosis/stricture preventing the advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD) Presence of any gastric condition which required endoscopic surveillance (e.g., known gastric intestinal metaplasia), Known vascular abnormalities, obligate therapeutic anticoagulation, and pregnancy/lactation Evidence of end-stage liver disease, including portal hypertension, ascites, and coagulopathy Positivity for hepatitis B virus or hepatitis C virus, current alcohol consumption of more than 20 g/day in females and more than 30 g/day in males on average, use of medications with reported hepato-steatogenic effect (amiodarone, tamoxifen, estrogens), and drug-induced liver disease Type 1 diabetes, Prior bariatric surgery, Autoimmune liver disease (antinuclear antibody titer >1/160), Wilson's disease, hemochromatosis, alpha1-antitrypsin deficiency, Known positivity for human immunodeficiency virus, a concomitant disease with reduced life expectancy, severe psychiatric condition, drug dependence, or inability to provide informed consent. The patient refuses or is unable to provide written informed consent Prior bariatric treatment procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endoscopic Sleeve Gastroplasty<br>endoscopic suturing of the stomach | Procedure: Endoscopic Sleeve Gastroplasty<br>* endoscopic suturing of the stomach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Controlled Attenuation Parameter of Steatosis | The CAP measures ultrasonic attenuation in the liver at 3.5 MHz using signals acquired by the FibroScan® M probe based on vibration-controlled transient elastography. The final CAP value, which ranges from 100 to 400 decibels per metre (dB/m), is the median of individual measurements. Higher measure indicates higher portion of liver affected by fatty change. | Baseline (Before ESG) | 
| Change in Controlled Attenuation Parameter of Steatosis | The CAP measures ultrasonic attenuation in the liver at 3.5 MHz using signals acquired by the FibroScan® M probe based on vibration-controlled transient elastography. The final CAP value, which ranges from 100 to 400 decibels per metre (dB/m), is the median of individual measurements. Higher measure indicates higher portion of liver affected by fatty change. | 6 months post ESG | 
| Change in Controlled Attenuation Parameter of Steatosis | The CAP measures ultrasonic attenuation in the liver at 3.5 MHz using signals acquired by the FibroScan® M probe based on vibration-controlled transient elastography. The final CAP value, which ranges from 100 to 400 decibels per metre (dB/m), is the median of individual measurements. Higher measure indicates higher portion of liver affected by fatty change. | 12 months post ESG | 
| Change in Liver Stiffness Measurement of Fibrosis | Liver stiffness result is measured in kilopascals (kPa) Range is 0-75kPa. Normal results are usually between 2 and 7 kPa. The highest possible result is 75 kPa. Higher results indicate liver disease. | Baseline (Before ESG) | 
| Change in Liver Stiffness Measurement of Fibrosis | Liver stiffness result is measured in kilopascals (kPa) Range is 0-75kPa. Normal results are usually between 2 and 7 kPa. The highest possible result is 75 kPa. Higher results indicate liver disease. | 6 months post ESG | 
| Change in Liver Stiffness Measurement of Fibrosis | Liver stiffness result is measured in kilopascals (kPa) Range is 0-75kPa. Normal results are usually between 2 and 7 kPa. The highest possible result is 75 kPa. Higher results indicate liver disease. | 12 months post ESG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric Evaluation | Changes in Anthropometric evaluation from baseline to 6 months post ESG | 6 months post ESG | 
| BMI Changes | Compare the change in BMI from baseline to the 6 months post ESG. Body Mass Index (BMI) is a person's weight in kilograms (or pounds) divided by the square of height in meters (or feet). | 6 months post ESG | 
| BMI Changes | Compare the change in BMI from baseline to the 12 months post ESG. Body Mass Index (BMI) is a person's weight in kilograms (or pounds) divided by the square of height in meters (or feet). | 12 months post ESG | 
| Excess Weight Loss Changes | Percent excess weight loss change from baseline to 6 months | 6 months post ESG | 
| Excess Weight Loss Changes | Percentage of excess weight loss change from baseline to 12 months | 12 months post ESG | 
| Total Body Weight Loss Changes | Percentage of total body weight loss (TBWL) from baseline to 6 months | 6 months post ESG | 
| Total Body Weight Loss Changes | Percentage of total body weight loss (TBWL) from baseline to 12 months | 12 months post ESG | 
| Absolute Body Weight Loss Changes | Percentage of Absolute Body Weight Loss from baseline to 6 months | 6 months post ESG | 
| Absolute Body Weight Loss Changes | Percentage of Absolute Body Weight Loss from baseline to 12 months | 12 months post ESG |