Clinical trial NCT03267615: VICIS - Vienna Cirrhosis Study
Official title: VICIS - Vienna Cirrhosis Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Cirrhosis
Portal Hypertension
Ascites
Variceal Hemorrhage
Hepatic Encephalopathy
Keywords: Liver Cirrhosis
Portal Hypertension
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with advanced chronic liver disease diagnosed and/or treated at the Medical University of Vienna will be screened for inclusion/exclusion criteria.

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.

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. 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.

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

Primary outcomes:
measure: Transplant-free survival
timeFrame: 01/FEB/2017 - 31/DECEMBER/2027
Secondary outcomes:
measure: Decompensation-free survival
timeFrame: 01/FEB/2017 - 31/DECEMBER/2027
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Thomas Reiberger, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hofer BS, Simbrunner B, Bauer DJM, Paternostro R, Schwabl P, Scheiner B, Semmler G, Hartl L, Jachs M, Datterl B, Staettermayer AF, Trauner M, Mandorfer M, Reiberger T. Acute hemodynamic response to propranolol predicts bleeding and nonbleeding decompensation in patients with cirrhosis. Hepatol Commun. 2022 Sep;6(9):2569-2580. doi: 10.1002/hep4.2021. Epub 2022 Jul 8.
citation: Scheiner B, Balcar L, Nussbaumer RJ, Weinzierl J, Paternostro R, Simbrunner B, Hartl L, Jachs M, Bauer D, Stattermayer AF, Semmler G, Pinter M, Ay C, Quehenberger P, Trauner M, Reiberger T, Lisman T, Mandorfer M. Factor VIII/protein C ratio independently predicts liver-related events but does not indicate a hypercoagulable state in ACLD. J Hepatol. 2022 May;76(5):1090-1099. doi: 10.1016/j.jhep.2021.12.038. Epub 2022 Jan 20.
citation: 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.
citation: Costa D, Simbrunner B, Jachs M, Hartl L, Bauer D, Paternostro R, Schwabl P, Scheiner B, Stattermayer AF, Pinter M, Trauner M, Mandorfer M, Reiberger T. Systemic inflammation increases across distinct stages of advanced chronic liver disease and correlates with decompensation and mortality. J Hepatol. 2021 Apr;74(4):819-828. doi: 10.1016/j.jhep.2020.10.004. Epub 2020 Oct 16.
citation: Raeven P, Baron-Stefaniak J, Simbrunner B, Stadlmann A, Schwabl P, Scheiner B, Schaden E, Eigenbauer E, Quehenberger P, Mandorfer M, Baron DM, Reiberger T. Thromboelastometry in patients with advanced chronic liver disease stratified by severity of portal hypertension. Hepatol Int. 2020 Dec;14(6):1083-1092. doi: 10.1007/s12072-020-10093-3. Epub 2020 Sep 30.
citation: 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.