Prediction of Decompensation and HCC Development in Advanced Chronic Liver Disease

NCT06523608 | Recruiting

• 1 other identifier: 2023-237-f-S
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (2)

• Mortality

  All-cause mortality rate and liver-related mortality rate

  2 years

• Liver transplantation

  Incidence of liver transplantation during follow-up period and time until liver transplantation.

  2 years

Secondary Outcomes (8)

• De novo HCC

  2 years

• Acute liver decompensations

  2 years

• Therapy in patients who develop HCC during follow-up

  2 years

• Analysis of cost-effectiveness of the new algorithm compared to the routine follow-up

  2 years

• Analysis of proteome and metabolome in patients included into the study

  2 years

Study Arms (2)

Control group

Patients in the control group are examined according to standard protocol (with a biannual follow-up) or more frequently when there is a development of decompensation or HCC.

Other: Standard survillance protocol

Group with stratified surveillance

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 are allocated for a further CT/MRI examination and an AFP examination to exclude HCC and receive another appointment for a hospital visit within 3 months. Low-risk patients receive an appointment in one year.

Other: Stratified survillance protocol

Interventions

Stratified survillance protocol OTHER

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.

Group with stratified surveillance

Standard survillance protocol OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients should be included in the study if they are hospitalized with suspected chronic liver liver disease of viral and/or steatotic origin.

You may qualify if:

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

You may not qualify if:

• 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).
• Human Immunodeficiency Virus (HIV) positive patients.
• Previous liver or other transplantation.
• Patients who decline to participate or who cannot provide prior written informed consent and when there is documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.
• Physician's denial (e.g. the investigator considers that the patient will not follow the protocol scheduled).

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

Related Publications (41)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Liver Diseases; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Jonel Trebicka, Prof. Dr. med.

  Department of Internal Medicine B, University Hospital Muenster, Muenster, Germany

  PRINCIPAL INVESTIGATOR

• Jonel Trebicka, Prof. Dr. med.

  European Foundation for Study of Chronic Liver Failure, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

• Jonel Trebicka, Prof. Dr. med.

  Department of Gastroenterology and Hepatology, Odense University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonel Trebicka, Prof. Dr. med.

CONTACT

+49 02518359689; jonel.trebicka@ukmuenster.de

Josune Cabello Calleja, PhD

CONTACT

+34 688689194; josune.cabello@ukmuenster.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of internal medicine B, University professor, Principal investigator

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 26, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

DE (1)