Nonalcoholic Steatohepatitis in Chinese Children: a Long Term Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Liver related death
研究概览
简要总结
Nonalcoholic steatohepatitis (NASH) is now recognised as an increasing clinical problem in children. Steatosis without significant liver cell injury or fibrosis is the most common form of nonalcoholic fatty liver disease (NAFLD) in both adults and children. Studies in the adult population have variably suggested that steatosis is a benign nonprogressive condition and NASH is recognised as a potentially serious condition with significantly risk of morbidity and mortality.
A growing body of evidence suggests that children with NASH frequently show histopathological features that differ from those of adults. The prevalence of this pattern in a wide range of paediatric cases as well as other histopathological lesions and their relevance and prognostic significance in children with NAFLD remains to be determined. Thus the investigators would like to conduct a study of biopsies and clinical information to document the histological features of paediatric NAFLD, to explore the natural history of paediatric NAFLD, and to determine the frequency and prognostic value of these features.
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
- 1 Year 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 1-18 with biopsy-proven NAFLD
- •Alcohol consumption less than 20g/day and 10g/day for boys and girls respectively
排除标准
- •with viral hepatitis, e.g. HBV, HCV
- •with a1-anti-trypsin disease
- •with autoimmune hepatitis
- •with Wilson disease
- •with liver impaired by drugs
结局指标
主要结局
Liver related death
时间窗: Through study completion, an average of 1 year
Whether the patients die from liver-related causes
次要结局
- Liver transplant(Through study completion, an average of 1 year)
- Complications of cirrhosis(Through study completion, an average of 1 year)
- Liver biopsy(Through study completion, an average of 2 year)
