VICIS - Vienna Cirrhosis Study

NCT ID: NCT03267615

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2027-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Thomas Reiberger

Univ.-Prof. Priv-Doz. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Reiberger, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Thomas Reiberger, M.D.

Role: CONTACT

thomas.reiberger@meduniwien.ac.at

+43140400 ext. 65890

Mattias Mandorer, M.D.

Role: CONTACT

mattias.mandorfer@meduniwien.ac.at

+43140400 ext. 47410

Facility Contacts

Thomas Reiberger, M.D.

Role: primary

thomas.reiberger@meduniwien.ac.at

+43140400 ext. 47440

Alexandra Weisgram

Role: backup

alexandra.weisgram@meduniwien.ac.at

+43140400 ext. 47410

References

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Reference Type: DERIVED

PMID: 36881247 (View on PubMed)

Balcar L, Krawanja J, Scheiner B, Paternostro R, Simbrunner B, Semmler G, Jachs M, Hartl L, Stattermayer AF, Schwabl P, Pinter M, Szekeres T, Trauner M, Reiberger T, Mandorfer M. Impact of ammonia levels on outcome in clinically stable outpatients with advanced chronic liver disease. JHEP Rep. 2023 Jan 23;5(4):100682. doi: 10.1016/j.jhepr.2023.100682. eCollection 2023 Apr.

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Simbrunner B, Semmler G, Stadlmann A, Scheiner B, Schwabl P, Paternostro R, Bucsics T, Bauer D, Eigenbauer E, Pinter M, Stattermayer AF, Quehenberger P, Marculescu R, Trauner M, Mandorfer M, Reiberger T. Vitamin A levels reflect disease severity and portal hypertension in patients with cirrhosis. Hepatol Int. 2020 Dec;14(6):1093-1103. doi: 10.1007/s12072-020-10112-3. Epub 2020 Dec 8.

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Simbrunner B, Marculescu R, Scheiner B, Schwabl P, Bucsics T, Stadlmann A, Bauer DJM, Paternostro R, Eigenbauer E, Pinter M, Stattermayer AF, Trauner M, Mandorfer M, Reiberger T. Non-invasive detection of portal hypertension by enhanced liver fibrosis score in patients with different aetiologies of advanced chronic liver disease. Liver Int. 2020 Jul;40(7):1713-1724. doi: 10.1111/liv.14498. Epub 2020 May 18.

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Other Identifiers

VICIS

Identifier Type: -

Identifier Source: org_study_id