NCT06523608

Prediction of Decompensation and HCC Development in Advanced Chronic Liver Disease

Prediction of Decompensation and HCC Development in Patients With Advanced Chronic Liver Disease by the PLEASE and M10S20 Algorithms

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: University Hospital Muenster · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients who are hospitalized with advanced chronic liver disease are randomly divided into two groups. Patients in the control group are examined according to the current clinical standard protocol (biannual follow-up) or more frequently when decompensation or HCC develops. Patients in the study group will be stratified for the risk of decompensation/mortality and de novo-HCC-risk, based on the M10S20 (\[Liver stiffness and MELD combined\]) and PLEASE (\[Platelet, Etiology, Age, Sex und Elastography\]) scores. High-risk patients will be allocated for a further computer tomography (CT) or magnetic resonance imaging (MRI) examination and an alpha-fetoprotein (AFP) examination to exclude HCC and receive another appointment for a hospital visit within 3 months. Low-risk patients could receive an appointment in one year. Patients in both arms, either outpatient or inpatient, will undergo at each visit an ultrasound examination with liver stiffness measurement and a routine blood test. Other examinations will be carried out according to standard medical care. Blood, urine and stool tests as well as instrumental diagnostics such as duplex ultrasound, CT, MRI, endoscopies, bone marrow punctures, elastographies, transjugular intrahepatic portosystemic shunt (TIPS) implantations, operations, etc. will be performed as part of the usual diagnostic clarification. Hepatic encephalopathy is a decompensation event that will be diagnosed based on the West-Haven criteria, the number-connection test, the flicker frequency analysis and electroencephalogram. Written consent is required for every admitted patient. Data protection concept: When a patient is enrolled in the study, a center-specific study ID is first assigned for the purpose of pseudonymization. The data collected is documented in an Excel spreadsheet. The assignment of the center-specific study ID to the respective patient is only possible for the respective investigator (Prof. Dr. Trebicka) and his staff (study nurse). For statistical evaluations, an analysis-specific data table will be created, which can be processed with an appropriate statistics program. Patients cannot be identified with the data collected and the scientific research that derives from it.

Conditions

• Liver Diseases
• Hepatocellular Carcinoma
• Hepatocarcinoma
• Advanced Chronic Liver Disease

Interventions

Type	Name	Description
OTHER	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.
OTHER	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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2024-07-26
• Last updated: 2025-12-22

Locations

1 site across 1 country: Germany