No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
600 (estimated)
Sponsor
University Hospital Muenster · Other
Who this trial is looking for
This trial is looking for patients with advanced chronic liver disease. Participants will be monitored to see how their condition develops and will receive appointments based on their level of risk.
Are You a Good Fit for This Trial?
You may be able to join if
I have advanced chronic liver disease.
You may not be able to join if
I am pregnant.
I am under 18 years old.
I have current cancer, except for non-melanocytic skin cancer.
I have severe extra-hepatic diseases.
I am HIV positive.
I have had a liver or other organ transplant.
I cannot provide consent.
My doctor does not think I can follow the study protocol.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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City
State
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Status
Eligibility Criteria
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 …
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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