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临床试验/NCT03267615
NCT03267615招募中不适用

VICIS - Vienna Cirrhosis Study

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
Transplant-free survival

研究概览

简要总结

Patients with advanced chronic liver diseases treated at the Vienna General Hospital of the Medical University of Vienna will be offered to participate in this prospective observational trial - including an optional participation in a biobank.

Clinical parameters and laboratory parameters will be recorded for all patients and patients will undergo a regular follow-up schedule with clinical visits at the Vienna General Hospital.

This study is linked to a biobank with serum/plasma, ascitic fluid, urine, GI tract mucosal biopsies, liver biopsies and stool collected from the study participants.

详细描述

Patients with advanced chronic liver disease (ACLD) as evident by HVPG>5mmHg or liver biopsy showing F3/F4 fibrosis or as suggested by liver stiffness measurement (LSM) ≥10kPa can be included in the VICIS study. Most patients will be recruited on the day of HVPG measurement performed for screening of clinically significant portal hypertension (CSPH) or on the day of upper GI endoscopy for screening for the presence of varices. Next to the detailed characterization of patients by epidemiologic, clinical and laboratory parameters, the degree of portal hypertension will be assessed by HVPG, liver (LSM) and spleen (SSM) stiffness will be assessed by transient elastography, the presence of ascites, splenomegaly, portosystemic collaterals, PVT and liver lesions will be assessed by ultrasound and optionally cross-sectional imaging.

In addition, patients will be asked to (optionally) participate in biobank sampling including serum/plasma, ascitic fluid, urine, GI tract mucosal biopsies, stool, liver biopsies and stool. All patients recruited in the VICIS study will be prospectively followed every 3 months (decompenated ACLD) or every 6 months (compensated ACLD) patients with clinical visits at the Cirrhosis Outpatient Clinic at the Vienna General Hospital. These assessments include a detailed assessment of risk factors (such as a structured interview of alcohol consumption), the recording of decompensating events (such as ascites, hepatic encephalopathy, variceal bleeding), screening for PVT and HCC, recording of medications and other clinically-relevant information.

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

入选标准

  • Age >18 years and <100 years
  • Diagnosis of advanced chronic liver disease (by liver stiffness ≥10kPa, HVPG>5mmHg or Histology F3/F4)
  • Written informed consent

排除标准

  • Withdrawal of written informed consent

结局指标

主要结局

Transplant-free survival

时间窗: 01/FEB/2017 - 31/DECEMBER/2027

Time from inclusion to death or liver transplantation

次要结局

  • Decompensation-free survival(01/FEB/2017 - 31/DECEMBER/2027)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Reiberger

Univ.-Prof. Priv-Doz. Dr.

Medical University of Vienna

研究点 (1)

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