NCT04850534已完成不适用
Evaluation and Prognostic Indications of Systemic Inflammation in Liver Cirrhosis Patients
Third Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2019年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Upper Gastrointestinal Bleeding
研究概览
简要总结
Investigate systemic inflammation in liver cirrhosis patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Decompensated liver cirrhosis, with endoscopy-verified high-risk esophagogastric varices;
- •Adult patients aged 18-75 years;
- •Willing to anticipate and informed consent form obtained
排除标准
- •History of prior radio-interventional therapy (TIPS or BRTO), liver transplantation, splenectomy, or hepatectomy;
- •Non-sinusoidal cirrhosis (e.g. vascular cirrhosis);
- •Coexistence with advanced hepatocellular carcinoma or other malignancies;
- •Coexistence with severe systemic diseases and less than 3 months of expected survival time;
- •Acute infection within 4 weeks before recruitment;
- •Antibiotic use within 4 weeks before recruitment;
- •Initial antiviral therapy for HBV or HCV within 4 weeks before recruitment;
- •Pregnant or lactating women;
- •Patients resistant to long-term follow-up
结局指标
主要结局
Upper Gastrointestinal Bleeding
时间窗: One Year
Overt upper GI bleeding due to esophagogastric varices, ulcers and other causes; Identified by clinical manifestations, lab tests and endoscopy and measured by number/proportion of patients
Death
时间窗: One Year
Deaths caused by variceal bleeding, hepatocellular carcinoma, liver failure, etc
次要结局
- New or worsening acute decompensation event other than upper GI bleeding(One Year)
- Liver transplantation/ Transfer to other non-endoscopic therapies(One Year)
研究者
Jinlai Liu
Clinical Professor
Third Affiliated Hospital, Sun Yat-Sen University
研究点 (1)
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