Benefits and Limitations of Transjugular Intrahepatic Portosystemic Shunts (TIPS) in Patients With Decompensated Liver Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change in Nutritional Status
研究概览
简要总结
This is a single center patient registry of patients receiving a transjugular intrahepatic portosystemic shunt (TIPS) at Hannover Medical School. By collecting and analyzing clinical data as well as blood samples, the overall aim is to optimize TIPS therapy (e.g. specify selection criteria).
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver cirrhosis
- •Indication for TIPS insertion
- •Treatment at the Department of Gastroenterology, Hepatology and Endocrinology of Hannover Medical School
- •Informed consent
排除标准
- •Pregnancy or Lactation
- •Age <18 years
- •Lack of Informed consent
- •Symptomatic anemia with Hb <7g/dl
结局指标
主要结局
Change in Nutritional Status
时间窗: 1 year
Nutritional Status will be measured by hand grip strength (dynamometer) in kg
Mortality
时间窗: 1 year
Patients who die within 1 year
Change in Quality of Life
时间窗: 1 year
Using the questionnaire short-form 36 (SF36) (Score range 0-100, higher scores correspond to better quality of life)
Occurrence of (Minimal) Hepatic Encephalopathy
时间窗: 1 year
Using the Portosystemic encephalopathy (PSE) syndrome test, critical flicker frequency (CFF) and animal naming test (S-ANT)
次要结局
- Change in different metabolites using mass spectroscopy (metabolomics measurements)(12 months)
- Analysis of stool samples(12 months)
- Change in inflammatory markers (e.g. cytokine)(12 months)
- Analysis of cellular immunity by collection of peripheral blood mononuclear cells (PBMCs)(12 months)
- Measurement of portal hypertension(6 months)