Actively Recruiting
Prediction of Decompensation and HCC Development in Advanced Chronic Liver Disease
Led by University Hospital Muenster · Updated on 2025-12-22
600
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 more frequently.
CONDITIONS
Official Title
Prediction of Decompensation and HCC Development in Advanced Chronic Liver Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is hospitalized or outpatient with advanced chronic liver disease based on BAVENO criteria
- Patient is 18 years or older
You will not qualify if you...
- Pregnancy
- Age under 18 years
- Current malignancy except non-melanocytic skin cancer
- Severe extra-hepatic diseases such as chronic renal failure requiring hemodialysis, severe heart disease (NYHA > II), severe chronic pulmonary disease (GOLD > III), severe neurological or psychiatric disorders
- HIV positive status
- Previous liver or other organ transplantation
- Declines participation or cannot provide informed consent and has no legal surrogate decision maker with unlikely recovery of consent ability
- Physician denies participation due to concerns about protocol adherence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Muenster
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
Research Team
J
Jonel Trebicka, Prof. Dr. med.
CONTACT
J
Josune Cabello Calleja, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here