Status:

RECRUITING

Prediction of Decompensation and HCC Development in Advanced Chronic Liver Disease

Lead Sponsor:

University Hospital Muenster

Conditions:

Liver Diseases

Hepatocellular Carcinoma

Eligibility:

All Genders

18+ years

Brief Summary

The aim of this observational study is to predict the short- and long-term development of acute severe disease events, de novo hepatocarcinoma (HCC) and mortality in patients with advanced chronic liv...

Detailed Description

Patients who are hospitalized with advanced chronic liver disease are randomly divided into two groups. Patients in the control group are examined according to the current clinical standard protocol ...

Eligibility Criteria

Inclusion

  • The patient admitted/referred to study center is hospitalized or is an outpatient with advanced chronic liver disease (based on the BAVENO criteria)

Exclusion

  • Pregnancy
  • Age \<18
  • Evidence of current malignancy except for non-melanocytic skin cancer
  • Presence or history of severe extra-hepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe heart disease (New York Heart Association (NYHA) \> II); severe chronic pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease (GOLD) \> III), severe neurological and psychiatric disorders).
  • Human Immunodeficiency Virus (HIV) positive patients.
  • Previous liver or other transplantation.
  • Patients who decline to participate or who cannot provide prior written informed consent and when there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.
  • Physician's denial (e.g. the investigator considers that the patient will not follow the protocol scheduled).

Key Trial Info

Start Date :

September 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 1 2027

Estimated Enrollment :

600 Patients enrolled

Trial Details

Trial ID

NCT06523608

Start Date

September 1 2024

End Date

September 1 2027

Last Update

December 22 2025

Active Locations (1)

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University Hospital Muenster

Münster, North Rhine-Westphalia, Germany, 48149