Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Chronic Liver Disease | — | UNRESOLVED | — |
| Hepatocarcinoma | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Diseases | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard survillance protocol | Other | — | UNRESOLVED |
| Stratified survillance protocol | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control group
- description
- 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.
- interventionNames
- Other: Standard survillance protocol
- label
- Group with stratified surveillance
- description
- 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.
- interventionNames
- Other: Stratified survillance protocol
Primary outcomes (2)
- measure
- Mortality
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (41)
- BACKGROUNDde Franchis R; Baveno V Faculty. Revising consensus in portal hypertension: report of the Baveno V consensus workshop on methodology of diagnosis and therapy in portal hypertension. J Hepatol. 2010 Oct;53(4):762-8. doi: 10.1016/j.jhep.2010.06.004. Epub 2010 Jun 27. No abstract available. PMID 20638742
- BACKGROUNDKamath PS, Wiesner RH, Malinchoc M, Kremers W, Therneau TM, Kosberg CL, D'Amico G, Dickson ER, Kim WR. A model to predict survival in patients with end-stage liver disease. Hepatology. 2001 Feb;33(2):464-70. doi: 10.1053/jhep.2001.22172. PMID 11172350
- BACKGROUNDJansen C, Moller P, Meyer C, Kolbe CC, Bogs C, Pohlmann A, Schierwagen R, Praktiknjo M, Abdullah Z, Lehmann J, Thomas D, Strassburg CP, Latz E, Mueller S, Rossle M, Trebicka J. Increase in liver stiffness after transjugular intrahepatic portosystemic shunt is associated with inflammation and predicts mortality. Hepatology. 2018 Apr;67(4):1472-1484. doi: 10.1002/hep.29612. Epub 2018 Feb 20. PMID 29059466
- BACKGROUNDPraktiknjo M, Book M, Luetkens J, Pohlmann A, Meyer C, Thomas D, Jansen C, Feist A, Chang J, Grimm J, Lehmann J, Strassburg CP, Abraldes JG, Kukuk G, Trebicka J. Fat-free muscle mass in magnetic resonance imaging predicts acute-on-chronic liver failure and survival in decompensated cirrhosis. Hepatology. 2018 Mar;67(3):1014-1026. doi: 10.1002/hep.29602. Epub 2018 Jan 24. PMID 29059469
- BACKGROUNDLehmann J, Praktiknjo M, Nielsen MJ, Schierwagen R, Meyer C, Thomas D, Violi F, Strassburg CP, Bendtsen F, Moller S, Krag A, Karsdal MA, Leeming DJ, Trebicka J. Collagen type IV remodelling gender-specifically predicts mortality in decompensated cirrhosis. Liver Int. 2019 May;39(5):885-893. doi: 10.1111/liv.14070. Epub 2019 Mar 7. PMID 30739387
- BACKGROUNDLuo X, Leanza J, Massie AB, Garonzik-Wang JM, Haugen CE, Gentry SE, Ottmann SE, Segev DL. MELD as a metric for survival benefit of liver transplantation. Am J Transplant. 2018 May;18(5):1231-1237. doi: 10.1111/ajt.14660. Epub 2018 Feb 19.