Prediction of Decompensation and HCC Development in Patients with Advanced Chronic Liver Disease by the PLEASE and M10S20 Algorithms

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

Locations
Other Locations
Germany
University Hospital Muenster
RECRUITING
Münster
Contact Information
Primary
Jonel Trebicka, Prof. Dr. med.
jonel.trebicka@ukmuenster.de
+49 02518359689
Backup
Josune Cabello Calleja, PhD
josune.cabello@ukmuenster.de
+34 688689194
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2027-09
Participants
Target number of participants: 600
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: University Hospital Muenster

This content was sourced from clinicaltrials.gov