VICIS - Vienna Cirrhosis Study (VICIS)
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- STATUS
- Recruiting
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- End date
- Dec 31, 2027
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- participants needed
- 10000
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- sponsor
- Medical University of Vienna
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) >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.
Details
| Condition | Liver Cirrhosis, Portal Hypertension, Ascites, Variceal Hemorrhage, Hepatic Encephalopathy |
|---|---|
| Clinical Study Identifier | NCT03267615 |
| Sponsor | Medical University of Vienna |
| Last Modified on | 25 February 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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