Establishment of Precise Histological Evaluation Criteria for Reversal of NASH Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reversal of NASH liver fibrosis
研究概览
简要总结
Collect confirmed cases of NAFLD patients and enroll them in the study. Select patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy, and collect clinical and pathological data for relevant evaluation and definition. Establish a NASH "fibrosis reversal" pathological evaluation system, based on a new reversal standard, establish non-invasive alternative indicators, and observe indicators.
详细描述
Confirmed NAFLD patients were enrolled, and those with NASH and fibrosis F2-4 stages confirmed by liver biopsy were selected, and clinical and pathological data were collected for relevant evaluation and definition. A NASH "fibrosis reversal" pathological evaluation system was established based on the new standard, and an alternative non-invasive indicator and observation index were established based on the reversal standard.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 70 years at the time of liver biopsy;
- •Gender is not limited;
- •Hepatic perforation suggested that NASH complicated with fibrosis stage F2-4;
- •Signed written informed consent.
排除标准
- •Combined HCV infection, HIV infection, alcoholic liver disease, autoimmune liver disease, genetic metabolic liver disease Disease, drug-induced liver injury and other chronic liver diseases;
- •Women during pregnancy;
- •There are the following conditions before liver perforation: HCC or possible HCC (imaging suggests malignant liver occupation); decompensation of cirrhosis (ascites, hepatic encephalopathy, gastrointestinal bleeding, hepatorenal syndrome, etc.); Patients with other malignant tumors; Recipients of liver transplantation;
- •Patients considered by the investigator to be unsuitable for this study.
结局指标
主要结局
Reversal of NASH liver fibrosis
时间窗: 12 months
Reversal of NASH liver fibrosis based on liver biopsy definition
次要结局
- Changes in LSM value(12 months)
- Changes in liver fat content(12 months)
- The dynamic changes of existing non-invasive evaluation models for fibrosis(12 months)
- Dynamic changes in metabolic indicators of NAFLD(12 months)
- The occurrence of cirrhosis(12 months)
- The occurrence of liver outcome events(12 months)
- Extrahepatic related events(12 months)
研究者
Minghui Li
Director and Professor of Hepatology Department 2
Beijing Ditan Hospital