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NCT Number: NCT03267615

VICIS - Vienna Cirrhosis Study

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.

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Location status: Recruiting

Location contact

Alexandra Weisgram

CONTACT

[email protected]

+43140400 ext. 47410

Bernhard Scheiner, M.D.

SUB_INVESTIGATOR

Mattias Mandorfer, M.D., Ph.D.

SUB_INVESTIGATOR

Philipp Schwabl, M.D.

SUB_INVESTIGATOR

Thomas Reiberger, M.D.

CONTACT

[email protected]

+43140400 ext. 47440

Thomas Reiberger, M.D.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Transplant-free survival

    Time frame: 01/FEB/2017 - 31/DECEMBER/2027

    Time from inclusion to death or liver transplantation

Secondary outcomes

  1. Decompensation-free survival

    Time frame: 01/FEB/2017 - 31/DECEMBER/2027

    Time from inclusion to decompensation, death or liver transplantation

Study contacts

Contact information is provided by the study sponsor or research team.

Mattias Mandorer, M.D.

CONTACT

[email protected]

+43140400 ext. 47410

Thomas Reiberger, M.D.

CONTACT

[email protected]

+43140400 ext. 65890

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Acronym: VICIS

Important dates

Study start
2017
Primary completion
2026
Study completion
2027
First posted
Aug 30, 2017
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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