VICIS - Vienna Cirrhosis Study

Recruiting

• Conditions: Ascites; Hepatic Encephalopathy; Liver Cirrhosis; Variceal Hemorrhage; Portal Hypertension

• Registration Number: NCT03267615
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-08-28
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-30
• Last Update Posted: 2024-01-03
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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

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Exclusion Criteria

• Withdrawal of written informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transplant-free survival	01/FEB/2017 - 31/DECEMBER/2027	Time from inclusion to death or liver transplantation

Secondary Outcome Measures

Name	Time	Method
Decompensation-free survival	01/FEB/2017 - 31/DECEMBER/2027	Time from inclusion to decompensation, death or liver transplantation

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria