VICIS - Vienna Cirrhosis Study

Sponsor

Medical University of Vienna (Other)

Overall Status

Recruiting

CT.gov ID

NCT03267615

Collaborator

(none)

10,000

Enrollment

Location

130.9

Anticipated Duration (Months)

76.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis Portal Hypertension Ascites Variceal Hemorrhage Hepatic Encephalopathy

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) >15kPa 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 monhts (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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

VICIS - Vienna Cirrhosis Study

Actual Study Start Date :

Feb 1, 2017

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Dec 31, 2027

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age >18 years and <100 years
Diagnosis of advanced chronic liver disease (by liver stiffness >15kPa, HVPG>5mmHg or Histology F3/F4)
Written informed consent