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Prediction of Decompensation and HCC Development in Advanced Chronic Liver Disease

Recruitingn/aAges 18 Years - anyAllUniversity Hospital Muenster
NCT06523608 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 liver disease using the M10S20 (Liver stiffness and Model for End-Stage Liver Disease Score \[MELD\] combined) and PLEASE (Platelet, Etiology, Age, Sex und Elastography) scores, as well as the validation of the cost-effectiveness of the algorithm. Patients in this study are randomly divided into two groups: * Control group: patients are examined according to the current clinical standard protocol (biannual follow-up). * Stratified surveillance program: * High-risk patients will receive an appointment for a hospital visit every 3 months. * Low-risk patients could receive an appointment in one year. When necessary, if decompensation develops or HCC occurs, patients could be followed-up mor

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📋 Eligibility rules (as published)
Inclusion Criteria: * The patient admitted/referred to study center is hospitalized or is an outpatient with advanced chronic liver disease (based on the BAVENO criteria) Exclusion Criteria: * 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).
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What it tests

  • Standard survillance protocol
  • Stratified survillance protocol
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Where

1 site
University Hospital Muenster
Münster, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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