VICIS - Vienna Cirrhosis Study

Last updated: December 30, 2023
Sponsor: Medical University of Vienna
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatic Encephalopathy

Liver Disease

Hepatic Fibrosis

Treatment

N/A

Clinical Study ID

NCT03267615
VICIS
  • Ages 18-100
  • All Genders

Study Summary

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.

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Withdrawal of written informed consent

Study Design

Total Participants: 10000
Study Start date:
February 01, 2017
Estimated Completion Date:
December 31, 2027

Study 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) ≥10kPa 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 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 the recording of decompensating events (such as ascites, hepatic encephalopathy, variceal bleeding), screening for PVT and HCC, and recording of medications.

Connect with a study center

  • Medical University of Vienna

    Vienna, 1090
    Austria

    Active - Recruiting

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