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VICIS - Vienna Cirrhosis Study

VICIS - Vienna Cirrhosis Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03267615
Acronym
VICIS
Enrollment
10000
Registered
2017-08-30
Start date
2017-02-01
Completion date
2027-12-31
Last updated
2025-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ascites, Hepatic Encephalopathy, Liver Cirrhosis, Portal Hypertension, Variceal Hemorrhage

Keywords

Liver Cirrhosis, Portal Hypertension

Brief 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 - 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.

Detailed 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. 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.

Interventions

None listed

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Withdrawal of written informed consent

Design outcomes

Primary

MeasureTime frameDescription
Transplant-free survival01/FEB/2017 - 31/DECEMBER/2027Time from inclusion to death or liver transplantation

Secondary

MeasureTime frameDescription
Decompensation-free survival01/FEB/2017 - 31/DECEMBER/2027Time from inclusion to decompensation, death or liver transplantation

Countries

Austria

Contacts

Primary ContactThomas Reiberger, M.D.
thomas.reiberger@meduniwien.ac.at+43140400
Backup ContactMattias Mandorer, M.D.
mattias.mandorfer@meduniwien.ac.at+43140400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026