VICIS - Vienna Cirrhosis Study

Обзор

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 - including an optional participation in a biobank. 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.

Подробное описание

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. Most patients will be recruited on the day of HVPG measurement performed for screening of clinically significant portal hypertension (CSPH) or on the day of upper GI endoscopy for screening for the presence of varices. Next to the detailed characterization of patients by epidemiologic, clinical and laboratory parameters, the degree of portal hypertension will be assessed by HVPG, liver (LSM) and spleen (SSM) stiffness will be assessed by transient elastography, the presence of ascites, splenomegaly, portosystemic collaterals, PVT and liver lesions will be assessed by ultrasound and optionally cross-sectional imaging.

In addition, patients will be asked to (optionally) 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 a detailed assessment of risk factors (such as a structured interview of alcohol consumption), the recording of decompensating events (such as ascites, hepatic encephalopathy, variceal bleeding), screening for PVT and HCC, recording of medications and other clinically-relevant information.

Первичные конечные точки

• Transplant-free survival [Срок оценки: 01/FEB/2017 - 31/DECEMBER/2027]

Вторичные конечные точки (1)

• Decompensation-free survival [Срок оценки: 01/FEB/2017 - 31/DECEMBER/2027]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Withdrawal of written informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Австрия · 1 центр

• Medical University of Vienna — Vienna

Публикации

• Simbrunner B, Semmler G, Bofill Roig M, Meyer EL, Balcar L, Jachs M, Hartl L, Hofer BS, Kramer G, Thoene P, Sebesta C, Dominik N, Marculescu R, Quehenberger P, Scheiner B, Schwabl P, Stattermayer AF, Trauner M, Reiberger T, Mandorfer M. Stage-Specific Drivers of Clinical Progression in Advanced Chronic Liver Disease. Clin Gastroenterol Hepatol. 2026 Jun 17:S1542-3565(26)00445-3. doi: 10.1016/j.cgh PMID 42309430
• Pfisterer N, Lie-Ungurean I, Maurer J, Bauer D, Hengstschlaeger H, Noe A, Balcar L, Scheiner B, Schwabl P, Marculescu R, Woran K, Mozayani B, Madl C, Trauner M, Mandorfer M, Reiberger T, Simbrunner B. The Link of Portal-Hypertensive Gastropathy to Anaemia, Systemic Inflammation and Disease Progression in Cirrhosis. Liver Int. 2026 Jun;46(6):e70700. doi: 10.1111/liv.70700. PMID 42174757
• Kramer G, Simbrunner B, Jachs M, Balcar L, Hofer BS, Dominik N, Hartl L, Schwarz M, Semmler G, Sebesta C, Thone P, Geisselbrecht S, Maasoumy B, Alvarez E, McCoy MS, Petrenko O, Reinis J, Schwabl P, Stattermayer AF, Trauner M, Mandorfer M, Reiberger T. Blood-based Vienna 3P/5P risk models accurately predict first hepatic decompensation in compensated advanced chronic liver disease. JHEP Rep. 2025 O PMID 41551411
• Jachs M, Carvalho T, Simbrunner B, Semmler G, Hartl L, Balcar L, Hofer BS, Thone P, Dominik N, Kramer G, Sebesta C, Schwarz M, Bauer D, Stattermayer AF, Pinter M, Trauner M, Reiberger T, Mandorfer M. Indocyanine Green Clearance Correlates With Biomarkers Reflecting Key Disease-Driving Mechanisms in Advanced Chronic Liver Disease and Predicts Acute-on-Chronic Liver Failure and Death. Aliment Pharma PMID 41194563
• Simbrunner B, Villesen IF, Semmler G, Balcar L, Kramer G, Almeida Calvao J, Hofer BS, Jachs M, Hartl L, Maurer J, Scheiner B, Zinober K, Marculescu R, Trauner M, Karsdal M, Reiberger T, Mandorfer M, Leeming DJ. Biomarkers of Extracellular Matrix Remodelling Are Linked to Severity and Outcome of Advanced Chronic Liver Disease. Aliment Pharmacol Ther. 2026 Mar;63(5):648-661. doi: 10.1111/apt.70407. PMID 41077886
• Dominik N, Simbrunner B, Scheiner B, Schwarz M, Hartl L, Jachs M, Balcar L, Semmler G, Kramer G, Sebesta C, Trauner M, Pinter M, Mandorfer M, Reiberger T, Hofer BS. Smoking Aggravates Inflammation, Fibrogenesis, Angiogenesis and Cancer Risk in Patients With Cirrhosis. Liver Int. 2025 Oct;45(10):e70314. doi: 10.1111/liv.70314. PMID 40899194
• Hartl L, Hintersteininger M, Simbrunner B, Jachs M, Hofer BS, Bauer DJM, Dominik N, Schwarz M, Balcar L, Kramer G, Kerbert AJC, Coenraad MJ, Thevenot T, Moreau R, Trebicka J, Claria J, Marculescu R, Trauner M, Mandorfer M, Reiberger T. The Vasopressin Biomarker Copeptin Is Linked to Systemic Inflammation and Refines Prognostication in Decompensated Cirrhosis. Clin Gastroenterol Hepatol. 2026 Jan;2 PMID 40467020
• Hofer BS, Simbrunner B, Konigshofer P, Brusilovskaya K, Petrenko O, Taru V, Sorz-Nechay T, Zinober K, Regnat K, Semmler G, Lackner C, Trauner M, Mandorfer M, Schwabl P, Reiberger T. Inflammation remains a dynamic component of portal hypertension in regressive alcohol-related cirrhosis. United European Gastroenterol J. 2025 Apr;13(3):317-329. doi: 10.1002/ueg2.12643. Epub 2024 Dec 21. PMID 39708052

Идентификаторы

NCT: NCT03267615 · VICIS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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