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Prediction of Decompensation and HCC Development in Advanced Chronic Liver Disease

NCT06523608 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2025-12-22

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University Hospital Muenster

    lead OTHER

Principal Investigators

  • Jonel Trebicka, Prof. Dr. med. · Department of Internal Medicine B, University Hospital Muenster, Muenster, Germany

  • Jonel Trebicka, Prof. Dr. med. · European Foundation for Study of Chronic Liver Failure, Barcelona, Spain

  • Jonel Trebicka, Prof. Dr. med. · Department of Gastroenterology and Hepatology, Odense University Hospital, Denmark

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06523608 on ClinicalTrials.gov