Noninvasive Tools for the Diagnosis of Porto-sinusoidal Vascular Disease: a Single-center, Prospective, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Searching for valid non-invasive tools for the diagnosis of PSVD
研究概览
简要总结
Patients treated with platinum-based chemotherapy drugs have the probability of developing PSVD. The diagnosis of PSVD depends on liver biopsy. In addition, the level of portal vein pressure has guiding value in the diagnosis and prognosis of PSVD. Many studies have shown that liver and spleen stiffness have high accuracy in diagnosis and prognosis. The purpose of this study is to evaluate the efficacy of the combination of liver and spleen stiffness in the diagnosis of PSVD and to search for effective biomarkers for the diagnosis of PSVD through a single-center, prospective, observational study.
详细描述
PSVD is a supplement to non-cirrhotic portal hypertension and is defined as a class of diseases with characteristic pathological changes based on portal vein or hepatic sinuses abnormalities without cirrhosis. Some patients treated with platinum-based chemotherapy drugs will develop PSVD, which is clinically manifested as portal hypertension related complications. The diagnosis of PSVD depends on liver biopsy. In addition, the level of portal vein pressure has guiding value in the diagnosis and prognosis of PSVD. However, liver biopsy and pressure measurement are invasive methods. Many studies have shown that liver and spleen stiffness have high accuracy in diagnosis and prognosis. The purpose of this study is to evaluate the efficacy of the combination of liver and spleen stiffness in the diagnosis of PSVD and to search for effective biomarkers for the diagnosis of PSVD through a single-center, prospective, observational study.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received platinum chemotherapy for organ tumors;
- •Ages 18-80;
- •sign the informed consent voluntarily.
排除标准
- •Liver pathology suggested cirrhosis;
- •Underwent liver transplantation;
- •Combined with hepatocellular carcinoma exceeding Milan criteria;
- •Complicated with severe heart, kidney, or lung failure;
- •Pregnant or lactating women;
- •Data is seriously missing;
- •Patients were judged not suitable for participation in this study by the researchers.
结局指标
主要结局
Searching for valid non-invasive tools for the diagnosis of PSVD
时间窗: 2 years
The sensitivity and specificity of the non-invasive models for the diagnosis of PSVD reached 85% and 60%, respectively
次要结局
- Patients died(3 years)
- Patients underwent liver transplantation(3 years)
- Patients developed portal-hypertension-related complications(3 years)
- Patients reached the final follow-up time(3 years)