Effectiveness of Endoscopic Sleeve Gastroplasty in Obese Patients With Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Controlled Attenuation Parameter of Steatosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Endoscopic Sleeve Gastroplasty
endoscopic suturing of the stomach
干预措施: Endoscopic Sleeve Gastroplasty (Procedure)
结局指标
主要结局
Change in Controlled Attenuation Parameter of Steatosis
时间窗: 12 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 Fibrosis
时间窗: 12 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 Controlled Attenuation Parameter of Steatosis
时间窗: Baseline (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 Steatosis
时间窗: 6 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 Fibrosis
时间窗: Baseline (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 Fibrosis
时间窗: 6 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.
次要结局
- Anthropometric Evaluation(6 months post ESG)
- Excess Weight Loss Changes(12 months post ESG)
- BMI Changes(12 months post ESG)
- Absolute Body Weight Loss Changes(12 months post ESG)
- Total Body Weight Loss Changes(12 months post ESG)
- Absolute Body Weight Loss Changes(6 months post ESG)
- Total Body Weight Loss Changes(6 months post ESG)
- BMI Changes(6 months post ESG)
- Excess Weight Loss Changes(6 months post ESG)
研究者
Shailendra Singh
Associate Professor
West Virginia University