Non-invasive Method for Predicting the Presence of Gastroesophageal Varices in Patients With Cirrhosis: a Prospective, Single-center Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 616
- 试验地点
- 1
- 主要终点
- 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, SSM, serum differential protein, platelet count, and EGD data to evaluate the clinical value of SSM and differential proteins in excluding cirrhosis of cirrhosis.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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •The age ranged from 18 to 75 years.
- •Clinical or pathological diagnosis of cirrhosis;
- •Electronic gastroscopy is planned;
- •To agree and sign the informed consent;
排除标准
- •Hepatocellular carcinoma or other malignant tumors have been or are currently diagnosed;
- •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
high-risk esophageal varices
时间窗: 2 years
Incidence of high-risk esophageal varices
次要结局
- bleeding event happen(2 years)