NCT05463445Unknown不适用
Multicenter Study of Clinical Characteristics and Management of Primary Sclerosing Cholangitis and IgG4-related Sclerosing Cholangitis in China.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The percentage of new occurrence of decompensated liver related events, malignancies, liver transplantation and liver-related death caused by PSC and IgG4-SC
研究概览
简要总结
The investigators aimed to collect demographic features and clinical outcomes in patients diagnosed with PSC and IgG4-SC by utilizing participants database from multiple medical centers across Mainland China. Cross-sectional studies will focus on characterizing clinical presentations and validating diagnostic and prognostic models on Chinese PSC and IgG4-SC patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years old,
- •Male or Female,
- •Patients admitted in our medical centers which met the PSC criteria according to The European Association for the Study of the Liver Clinical Practice Guidelines "Management of cholestatic liver diseases" in 2009; or patients diagnosed with IgG4-SC which met initially using the Japan Pancreas Society criteria and confirmed using HISORt criteria.
排除标准
- •Female subjects who is pregnant, breastfeeding or is considering being pregnant during the study;
- •History of other malignancies, including hematological tumors, solid tumors except hepatobiliary system;
- •History of infectious diseases, including hepatis A, B, C, E and tuberculosis.
结局指标
主要结局
The percentage of new occurrence of decompensated liver related events, malignancies, liver transplantation and liver-related death caused by PSC and IgG4-SC
时间窗: 1 year
describe the characteristics and clinical outcomes of PSC and IgG4-SC patients among multiple medical centers in China
次要结局
未报告次要终点
研究者
ma xiong
Principal Investigator
RenJi Hospital
研究点 (1)
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