Prediction of Decompensation and HCC Development in Advanced Chronic Liver Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Muenster
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
This trial does not accept healthy volunteersQualifiers
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 population
Patients should be included in the study if they are hospitalized with suspected chronic liver liver disease of viral and/or steatotic origin.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard survillance protocol
Other interventionPatients 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
Other interventionBased 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Control group1 intervention
Group B: Group with stratified surveillance1 intervention
Trial outcomes
Primary outcomes
1
Mortality
All-cause mortality rate and liver-related mortality rate
Time frame
2 years2
Liver transplantation
Incidence of liver transplantation during follow-up period and time until liver transplantation.
Time frame
2 yearsSecondary outcomes
1
De novo HCC
Prediction of the risk of de novo HCC in patients with advanced chronic liver disease, based on the stratified surveillance, which can lead to earlier detection and treatment.
Time frame
2 years2
Acute liver decompensations
The acute occurrence of one or more complications of chronic portal hypertension, such as in patients with liver cirrhosis, a stable condition can develop into an acute decompensation. There is as well a new syndrome in patients with liver cirrhosis, which is characterized by a significantly increased hospitalization and a short-term (28-day) mortality rate. This syndrome is known as acute-on-chronic liver liver failure (ACLF). Portal hypertension is the driving force behind acute decompensation, while in the course of further decompensation and development of ACLF, an increasing, severe systemic inflammatory reaction is added.
Time frame
2 years3
Therapy in patients who develop HCC during follow-up
Assesment in the electronic case report form of number and type of therapies used to treat HCC (liver ablation, liver resection, chemoembolization, radiation or systemic therapy) when the patients develop HCC during the follow-up period.
Time frame
2 years4
Analysis of cost-effectiveness of the new algorithm compared to the routine follow-up
This outcome will be measured using the Markov model, which compares effectiveness based on Quality-adjusted life-years (QALYs) to the costs of each algorithm.
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov