NCT03144700招募中不适用
The Natural History and Prognostic Factors of Compensated Cirrhosis: An Ambi Prospective Cohort Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Development of ascites, jaundice, encephalopathy or gastrointestinal hemorrhage) during the follow up period of 2 yeas
研究概览
简要总结
Study Design and Methodology
- Study Population:Compensated Cirrhosis
- Study Design: An Ambi Prospective Cohort study
- Study Period: 2 Years
- Sample size: Retrospective- All patients from Jan 2010 to Mar 2017 Prospective- Assuming the incidence of clinical decompensation is 5%/year.With alpha of 5%, power 80% we need to enroll 138 cases. Further assuming 20% drop out 166 cases will be enrolled.
- Intervention: This is an observational study. No intervention will be given.
Monitoring and assessment: All the routine investigation and clinical information will be collected at 6, 12,18 and 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Age 18 to 75 years
- •Compensated cirrhosis
- •Biopsy proven cirrhosis or LSM > 12.5 Kpa.
排除标准
- •Any current or prior clinical decompesnation (ascites, jaundice, encephalopathy or gastrointestinal hemorrhage).
- •Pregnant Women
- •Hepatocellular Carcinoma
- •Known case of severe cardiopulmonary disease
- •Known case of severe Hepato Pulmonary Syndrome
结局指标
主要结局
Development of ascites, jaundice, encephalopathy or gastrointestinal hemorrhage) during the follow up period of 2 yeas
时间窗: 2 years
次要结局
- Number of patients develop Minimal Hepatic Encephalopathy (MHE) during follow up period of 2 years.(2 years)
- Survival during the period of 2 years.(2 years)
- Patients with new onset/progression of esophageal varices during the period of 2 years(2 years)
- Reduction in portal pressure with >20% from baseline at 1 year(1 year)
- Number of patients develop hepatocellular carcinoma (HCC) during follow up period 2 years.(2 years)
- Number of patients develop Pulmonary Syndrome (HPS) during follow up period of 2 years.(2 years)
- Number of patients develop Hypersplenism during follow up period of 2 years.(2 years)
- Reduction in portal pressure with >20% from baseline at 6 months(6 months)
- Number of patients develop Hepatic osteodystrophy during follow up period of 2 years.(2 years)
- Reduction in portal pressure with >20% from baseline at 2 year.(2 year)
研究者
研究点 (1)
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