Combined Endoscopic Ultrasound Guided Core Liver Biopsy and Intragastric Balloon Placement for the Diagnosis and Management of Nonalcoholic Steatohepatitis and Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 21
- 主要终点
- Weight Loss Achieved With Intragastric Balloon (IGB)
研究概览
简要总结
This study is designed to investigate the impact of weight loss achieved with the IGB on NASH with early fibrosis in a select cohort of patients with obesity preselected to have a high pre-test probability of having NASH with early fibrosis based on magnetic resonance elastography (MRE)-Hepatogram. In addition, this study will explore potential non-invasive imaging criteria for NASH and early fibrosis using EUS-Elastography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Non-alcoholic Steatohepatitis with early evidence of fibrosis as seen on MRE-hepatogram
- •Referred clinically for an intragastric balloon placement for weight loss
排除标准
- •Women who are pregnant or plan to be pregnant or are breastfeeding
- •Previous history of gastric surgery
- •Current or recent (within 6 months) gastric or duodenal ulcers
- •Gastroparesis
- •Liver cirrhosis
- •Coagulopathy or active use of coagulation
- •Inability to provide a written informed consent
研究组 & 干预措施
Single
All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy.
干预措施: Orbera Intragastric Balloon (Device)
Single
All subjects will be receiving the Orbera Intragastric Balloon and will be undergoing Endoscopic Ultrasound guided core liver biopsy.
干预措施: Endoscopic Ultrasound Guided Core Liver Biopsy (Procedure)
结局指标
主要结局
Weight Loss Achieved With Intragastric Balloon (IGB)
时间窗: Baseline to 6 months post-procedure
Total number of subjects with two points or greater improvement on objective Non-alcoholic Steatohepatitis (NASH) histopathological parameters. The NAS scale can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2).
次要结局
- Diagnosis of NASH and Early Fibrosis by Endoscopic Ultrasound (EUS) Guided Liver Core Biopsies(Baseline to 6 months post-procedure)