Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Standard survillance protocol
  • Stratified survillance protocol

Treatment groups

600 Participants
are divided into 2 treatment groups

Locations

1
University Hospital Muenster48149, MünsterNorth Rhine-Westphalia, Germany

Sponsors and collaborators

University Hospital Muenster

Lead sponsor

Source ClinicalTrials.gov