Transjugular Intrahepatic Portosystemic Shunt (TIPS) for the Treatment of Portal Hypertension: an Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Transplantation-free survival
研究概览
简要总结
Patients with clinically significant portal hypertension allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Medicine II of the University Medical Center Freiburg, Germany will be offered to participate in this prospective observational trial.
Clinical and laboratory as well as outcome parameters will be assessed before and within the first 12 months after TIPS implantation following a regular follow-up schedule with clinical visits at the University Medical Center Freiburg. During follow-up visits, serum/plasma samples and peripheral blood mononuclear cells (PBMC) are collected and stored in a associated biobank.
详细描述
Patients with clinically significant cirrhotic and non-cirrhotic portal hypertension who are allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) can be included in this observational study. Further patients who have been treated between 01/01/2005 and the start of the prospective part of this study (01/01/2023) will be included retrospectively in this registry.
Patients who are allocated to TIPS implantation will be recruited the day before TIPS implantation. Detailled patient characteristics, epidemiologic, clinical, imaging and laboratory parameters will be assessed and included in an electronic database. Further, interventional data of TIPS implantation will be included in the database.
Apart from these data, patients will be asked to participate in biobank sampling including serum/plasma and peripheral blood mononuclear cells (PBMC) samples from the peripheral veins and from the liver and portal vein that will be taken during TIPS implantation.
All patients recruited in this registry will be followed-up for at least 12 months with regular visits 3, 6 and 12 months after TIPS implantation.
Outcome parameters including development of post-TIPS hepatic encephalopathy, acute- on chronic liver failure (ACLF), infections, recurrence of clinically significant portal hypertension, need for TIPS revision and death and liver transplantation will be assessed.
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
- •Patients allocated to TIPS implantation due to clinically significant cirrhotic and non-cirrhotic portal hypertension
排除标准
- •Withdrawal of written informed consent
研究组 & 干预措施
Patients allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS)
Patients allocated to implantation of a transjugular intrahepatic portosystemic shunt (TIPS) due to cirrhotic and non-cirrhotic portal hypertension
干预措施: Implantation of a transjugular intrahepatic portosystemic shunt (TIPS) (Device)
结局指标
主要结局
Transplantation-free survival
时间窗: 01/01/2023-31/12/2033
Time from study inclusion to death or liver transplantation
次要结局
- Impact of osteoporosis on prognosis and decompensating events after TIPS(01/01/2023-31/12/2033)
- Impact of sarcopenia on prognosis and decompensating events after TIPS(01/01/2023-31/12/2033)
- Periinterventional complications(01/01/2023-31/12/2033)
- Time to development of post-TIPS hepatic encephalopathy(01/01/2023-31/12/2033)
- Time to development of post-TIPS acute- on chronic liver failure (ACLF)(01/01/2023-31/12/2033)
- Prevalence of osteoporosis in patients with TIPS implantation(01/01/2023-31/12/2033)
- Prevalence of sarcopenia in patients with TIPS implantation(01/01/2023-31/12/2033)
- Time to development of post-TIPS infections/sepsis(01/01/2023-31/12/2033)
- Time to need for TIPS revision(01/01/2023-31/12/2033)
研究者
Prof. Dr. Dominik Bettinger
MD
University Hospital Freiburg