Prediction of Decompensation and HCC Development in Advanced Chronic Liver Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard survillance protocol: Patients will be followed every 6 months. They will undergo at each visit an ultrasound examination including liver stiffness and a routine blood test, including AFP. Other examinations are carried out according to the standard of medical care. Blood, urine and stool tests as well as instrumental diagnostics such as duplex ultrasound, computer tomography, MR-tomography, endoscopies, bone marrow punctures, elastographies, TIPS implantations, operations, etc. will be performed as part of the usual diagnostic clarification.

Stratified survillance protocol: Based on PLEASE and M10LS20 scores, patients will be followed every 3 or 12 months. Low-risk patients will be followed once per year, and high-risk patients every 3 months. They will undergo at each visit an ultrasound examination including liver stiffness and a routine blood test, including AFP. Other examinations are carried out according to the standard of medical care. Blood, urine and stool tests as well as instrumental diagnostics such as duplex ultrasound, computer tomography, MR-tomography, endoscopies, bone marrow punctures, elastographies, TIPS implantations, operations, etc. will be performed as part of the usual diagnostic clarification.

Study 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 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

Primary outcome measure(s)

• Mortality — 2 years
  All-cause mortality rate and liver-related mortality rate
• Liver transplantation — 2 years
  Incidence of liver transplantation during follow-up period and time until liver transplantation.

Trial sites (1)

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