Predicting liver disease complications and cancer development in patients
Prediction of Decompensation and HCC Development in Patients With Advanced Chronic Liver Disease by the PLEASE and M10S20 Algorithms
This study is testing if a new way of monitoring patients with advanced liver disease can help predict serious health issues and cancer better than standard care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Muenster Academic / other |
| Locations | 1 site (Münster, North Rhine-Westphalia) |
| Trial ID | NCT06523608 on ClinicalTrials.gov |
What this trial studies
This observational study aims to predict the short- and long-term risks of severe disease events, hepatocellular carcinoma (HCC), and mortality in patients with advanced chronic liver disease. Patients will be randomly assigned to either a control group, which follows standard clinical protocols, or a stratified surveillance program based on their risk levels determined by specific scoring systems. High-risk patients will receive more frequent monitoring and additional imaging tests, while low-risk patients will have less frequent follow-ups. The study also seeks to validate the cost-effectiveness of this risk stratification approach.
Who should consider this trial
Good fit: Ideal candidates are hospitalized or outpatient individuals diagnosed with advanced chronic liver disease.
Not a fit: Patients with current malignancies, severe extra-hepatic diseases, or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and early intervention for patients at high risk of liver disease complications and HCC.
How similar studies have performed: Other studies have shown promise in using risk stratification for monitoring liver disease, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patient admitted/referred to study center is hospitalized or is an outpatient with advanced chronic liver disease (based on the BAVENO criteria) Exclusion Criteria: * 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).
Where this trial is running
Münster, North Rhine-Westphalia
- University Hospital Muenster — Münster, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Jonel Trebicka, Prof. Dr. med. — Department of Internal Medicine B, University Hospital Muenster, Muenster, Germany
- Study coordinator: Jonel Trebicka, Prof. Dr. med.
- Email: jonel.trebicka@ukmuenster.de
- Phone: +49 02518359689
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.