Effect of Portal Vein Thrombosis on the Prognosis of Liver Cirrhosis: A Single-center, Prospective, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 475
- 试验地点
- 1
- 主要终点
- Recurrent bleeding
研究概览
简要总结
The prevalence of portal vein thrombosis (PVT) in patients with liver cirrhosis is 5-20%. Current evidence regarding the effect of portal vein thrombosis on the prognosis of cirrhotic patients remains under debate. Considering that PVT potentially elevates the portal pressure and thereby increase the risk of variceal bleeding, we focus on the patients with high-risk varices and variceal bleeding as the study population. Thus, the main goals are to analyze the effect of PVT on the incidence of first variceal bleeding in patients without any prior bleeding history but with high-risk varices, the incidence of recurrent variceal bleeding in patients with a history of variceal bleeding, and the treatment failure rate of variceal bleeding in patients with acute variceal bleeding. Certainly, the survival is also observed in all patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of liver cirrhosis.
- •Patients should be diagnosed with high-risk varices endoscopically, or a prior history of variceal bleeding, or an episode of acute variceal bleeding.
- •Patients agreed to undergo endoscopy to evaluate the presence and severity of varices.
- •Patients agreed to undergo contrast-enhanced CT scans to evaluate the portal vein patency. But if an abdominal contrast-enhanced CT scans was performed within 3 months after admission, it was not necessarily repeated.
排除标准
- •Non-cirrhotic patients.
- •Malignancy.
- •Contrast-enhanced CT scans were neither feasible nor available.
- •Severe cardiopulmonary diseases.
- •Severe infectious diseases.
- •Pregnant or breastfeeding.
- •Allergic to contrast agents.
- •Poor adherence.
结局指标
主要结局
Recurrent bleeding
时间窗: 0-24 months
As for the patients with a prior history of bleeding, the recurrent bleeding was observed.
Treatment failure rate of acute variceal bleeding
时间窗: 5 days
As for the patients with acute variceal bleeding, the 5-day treatment failure of acute bleeding was observed.
Overall survival
时间窗: 6-24 months
First bleeding
时间窗: 0-24 months
As for the patients without any prior history of bleeding but with high-risk varices, the first bleeding was observed.
次要结局
未报告次要终点
研究者
Xingshun Qi
Dr.
General Hospital of Shenyang Military Region