Prediction of Decompensation and HCC Development in Advanced Chronic Liver Disease
NCT ID: NCT06523608
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2024-09-01
2027-09-30
Brief Summary
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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
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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University Hospital Muenster
OTHER
Responsible Party
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Prof. Dr. Jonel Trebicka
Head of department of internal medicine B, University professor, Principal investigator
Principal Investigators
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Jonel Trebicka, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine B, University Hospital Muenster, Muenster, Germany
Jonel Trebicka, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
European Foundation for Study of Chronic Liver Failure, Barcelona, Spain
Jonel Trebicka, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology and Hepatology, Odense University Hospital, Denmark
Locations
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University Hospital Muenster
Münster, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Facility Contacts
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Jonel Profesor Dr. Dr. med Trebicka
Role: primary
Josune Cabello Calleja
Role: backup
References
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Other Identifiers
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2023-237-f-S
Identifier Type: -
Identifier Source: org_study_id