Vienna Vascular Liver Disease Study: Characterization of Patients With Vascular Liver Disease - a Registry With Biobank
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Hepatic Decompensation
研究概览
简要总结
The aim of this Register Trial is to systematically study the epidemiology, risk factors, liver function as well prognosis of patients with vascular liver diseases. Furthermore, important clinical parameters will be assessed in order to evaluate patients' coagulation status and in order to develop new biomarkers derived from blood, urine, stool or ascites of patients as well as histological samples from the upper / lower GI-tract or the liver in order to better understand the natural history of vascular liver diseases.
详细描述
We will include patients with vascular liver diseases, including
- portal vein thrombosis (PVT)
- Budd-Chiari Syndrome (BCS)
- Heredetary Hemorrhagic Teleangiectasia (HHT, or Osler-Rendu Disease)
- Noncirrhotic-portal hypertension (NCPH) and Porto-sinusoidal vascular disorder
- Cirrhosis cardiaque if the fulfill inclusion/exclusion criteria and provide written informed consent. Participation in the biobank is optional for the patients. In particular, we will study the natural course of the patients in regard to hepatic decompensation (ascites, variceal bleeding, hepatic encephalopathy), need for intensified treatment (TIPS, ICU, liver transplantation) and survival.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a vascular liver disease by imaging (sonography, CT, MRI), transient elastography or liver histology
- •PVT: Portal vein thrombosis
- •NCPH: non-cirrhotic Portal Hypertension
- •PSVD: porto-sinusoidal vascular disorder
- •BCS: Budd-Chiari-Syndrome
- •SOS: sinusoidal occlusive disease
- •HHT: hereditary hemorrhagic teleangiectasia
- •CIRCAD: cirrhosis cardiaque
- •Age >18 years and <100 years
- •Written informed consent obtained
排除标准
- •withdrawal of written informed consent
结局指标
主要结局
Hepatic Decompensation
时间窗: Up to 10 years (=Study Period)
Any first hepatic decompensation: variceal bleeding, new onset of ascites, new onset of hepatic encephalopathy, new onset of jaundice
次要结局
- Liver-related death(Up to 10 years (=Study Period))
- Coagulation status(Up to 10 years (=Study Period))
研究者
Thomas Reiberger
Assoc.-Prof. Priv.-Doz. Dr.
Medical University of Vienna