VICIS - Vienna Cirrhosis Study

Liver Cirrhosis Clinical Trial

— VICIS  

Official title:

VICIS - Vienna Cirrhosis Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03267615
• Other study ID #: VICIS
• Status: Recruiting
• Start date: February 1, 2017
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2023
• Source: Medical University of Vienna
• Contact: Thomas Reiberger, M.D.
• Phone: +43140400
• Email: thomas.reiberger[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Brain Diseases
• Fibrosis
• Hemorrhage
• Hepatic Encephalopathy
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension
• Variceal Hemorrhage

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplant-free survival	Time from inclusion to death or liver transplantation	01/FEB/2017 - 31/DECEMBER/2027
Secondary	Decompensation-free survival	Time from inclusion to decompensation, death or liver transplantation	01/FEB/2017 - 31/DECEMBER/2027