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Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05507151

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot listed
ConditionNonalcoholic Fatty Liver Disease

Full registry criteria

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

Treatments and study arms

Endoscopic Sleeve Gastroplasty

Procedure

endoscopic suturing of the stomach

Primary outcomes

Change in Controlled Attenuation Parameter of SteatosisBaseline (Before ESG)

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.

Change in Controlled Attenuation Parameter of Steatosis6 months post ESG

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.

Change in Controlled Attenuation Parameter of Steatosis12 months post ESG

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.

Change in Liver Stiffness Measurement of FibrosisBaseline (Before ESG)

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.

Change in Liver Stiffness Measurement of Fibrosis6 months post ESG

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.

Change in Liver Stiffness Measurement of Fibrosis12 months post ESG

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

West Virginia University🇺🇸 Morgantown, West Virginia, United States
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