VICIS - Vienna Cirrhosis Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 1000
Summary
- Conditions
- Ascites
- Hepatic Encephalopathy
- Liver Cirrhosis
- Portal Hypertension
- Variceal Hemorrhage
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 100 years
- Gender
- Both males and females
Description
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) >15kPa can be included in the VICIS study. In fact most patients will be recruited on the day of HVPG measurement for screening for...
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) >15kPa can be included in the VICIS study. In fact most patients will be recruited on the day of HVPG measurement for screening for clinically significant portal hypertension (CSPH) or on the day of upper GI endoscopy for screening for the presence of varices. Next to the detailled characterization of patient characteristics by epidemiologic, clinical and laboratory parameters, the degree of portal hypertension will be assessed by HVPG, liver stiffness will be assessed by transient elastography, the presence of ascites, splenomegaly, portosystemic collaterals, PVT and liver lesions will be assessed by ultrasound. In addition, the included patients will be asked to 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 monhts (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 the recording of decompensating events (such as ascites, hepatic encephalopathy, variceal bleeding), screening for PVT and HCC, and recording of medications.
Tracking Information
- NCT #
- NCT03267615
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Thomas Reiberger, M.D. Medical University of Vienna