Southern Medical University of Nanfang Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 992
- 试验地点
- 1
- 主要终点
- Incidence of high-risk esophageal varices
研究概览
简要总结
Gastroesophageal varices are a complication of portal hypertension in cirrhosis.Endoscopy is an unsatisfactory screening test.In this prospective clinical study,we will enroll patients with cirrhosis of various causes, all of whom undergo laboratory tests, elastography, and serum proteomic differential protein testing, including liver elastography (LSM) and spleen elastography (SSM). Baveno VI or expanded BavenoVI criteria are validated by comparing patients' LSM and PLT. LSM, SSM, serum differential protein, platelet count, and EGD data to evaluate the clinical value of SSM and differential proteins in excluding cirrhosis with varices. At the same time, a new predictive model of variceal varices will be established to evaluate the diagnostic value of SSM and differential protein for esophagogastric varices, and a non-invasive method for reliably predicting and evaluating cirrhosis with esophageal varices will be found. And each patient will be followed up every 6 months to 1 year, and the outcome event will be recorded.
详细描述
Gastroesophageal varices are a complication of portal hypertension in cirrhosis.Endoscopy is invasive method as an unsatisfactory screening test.In this prospective clinical study, we will enroll patients with cirrhosis of various causes, all of patients whom undergo laboratory tests, elastography, and serum proteomic differential protein testing, including LSM and SSM. Baveno VI or expanded BavenoVI criteria are validated by comparing patients' LSM and PLT. LSM,SSM, serum differential protein, platelet count, and EGD data to evaluate the clinical value of SSM and differential proteins in excluding cirrhosis with varices. At the same time, based on SSM and serum differential protein, a new predictive model of variceal varices will be established to evaluate the diagnostic value of SSM and differential protein for esophagogastric varices, and a non-invasive method for reliably predicting and evaluating cirrhosis with esophageal varices will be found. And each patient will be followed up every 6 months to 1 year, and the outcome event will be recorded.
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
- •The age ranged from 18 to 80 years.
- •Clinical or pathological diagnosis of cirrhosis;
- •Electronic gastroscopy is planned;
- •To agree and sign the informed consent;
排除标准
- •1.Orthotopic liver transplantation patients;
- •Patients who have undergone transjugular intrahepatic portosystemic shunt (TIPS),or previous surgical shunt;
- •Pregnant women;
- •Neurological or psychiatric disorders;
结局指标
主要结局
Incidence of high-risk esophageal varices
时间窗: 4 years
Incidence of high-risk esophageal varices
次要结局
- Incidence of hemorrhagic events(4 years)
- Incidence of Clinical decompensation events and deaths(4 years)