Prospective Studies on the Immunopathogenesis of Fibrosis in Acute and Chronic Liver Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Liver Steatosis
研究概览
简要总结
The immune system is thought to play a key role in the development of liver inflammation and subsequent liver fibrosis or cirrhosis.
In the case of viral hepatitis and autoimmune hepatitis, for example, numerous studies have focused on the acquired antigen-specific immunity. However, the liver is the site of increased occurrence of the components of the innate immune response (NK and NKT cells) and, in contrast to T cells, these T cells, these do not require antigen presentation.
Therefore, the present study was designed to determine which cellular components of the (NK, NKT, dendritic cells, macrophages) or the acquired immune response (CD4, CD8) or which network of immune cells is involved in the immunopathogenesis of progressive liver inflammation or the development of liver fibrosis.
The aim is to identify lymphocyte populations that exhibit either prognostically favorable or unfavorable characteristics. This should allow conclusions to be drawn for a more targeted and individualized therapy of the respective chronic liver diseases.
详细描述
In patients with acute liver inflammation (e.g., autoimmune hepatitis, viral hepatitis) or chronic inflammation (e.g., ethyltoxic, viral hepatitis, fatty liver, autoimmune hepatitis, colorectal liver metastases, HCC) or liver fibrosis, the cellular immune response will be prospectively investigated and compared with liver healthy control patients.
For this purpose, patients with known or unknown liver disease will be tested during inpatient stays or during a visit to the outpatient clinic after written consent has been obtained.
Blood is then processed for further immunological cell analyses and finally frozen in liquid nitrogen. If a liver biopsy is taken from the patient as part of the clinical diagnostics during an inpatient stay or if a liver biopsy or liver resection is performed during a procedure in the OR, tissue that is not required for diagnostic purposes should be frozen for further immunological cell analysis.
If patients undergoing elective surgery in the abdominal cavity are suspected of having a liver disease (e.g., altered liver parameters in the blood) and a wedge biopsy of the liver will be performed intraoperatively for diagnostics, tissue that is not required for diagnostic purposes should be prepared for further immunological cell analysis.
In addition, a part of the liver tissue obtained should be preserved for later genetic studies, e.g. in RNA-later.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic liver disease up to progressive cirrhosis (e.g. ethyltoxic, Viral hepatitis, fatty liver, autoimmune hepatitis, colorectal liver metastases, HCC).
- •Patients with elevated liver values undergoing elective abdominal surgery.
- •As comparison groups patients with acute hepatitis (e.g. viral or autoimmune genesis) and patients without liver disease.
排除标准
- •Age under 18
结局指标
主要结局
Liver Steatosis
时间窗: Day 0
Stage of liver steatosis in histology (NASH activity score (1 - 8))
Liver fibrosis
时间窗: Day 0
Stage of liver fibrosis in histology (Ishak-score (1 - 6))
次要结局
- Survival(After 3 years)
研究者
Edward Geissler
Head of Exp. Surgery
University of Regensburg