[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556323":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":37,"locations":46,"responsibleParty":69,"collaborators":10,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":10,"enrollmentInfo":82,"targetDuration":85,"studyType":86,"phases":10,"briefSummary":87,"conditions":88,"keywords":10,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"University Hospital Muenster","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group",null,"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.",[13],"Other: Standard survillance protocol",{"label":15,"type":10,"description":16,"interventionNames":17},"Group with stratified surveillance","Patients in the study group will be stratified for the risk of decompensation\u002Fmortality and de novo-HCC-risk, based on the M10S20 (\\[Liver stiffness and MELD combined\\]) and PLEASE (\\[Platelet, Etiology, Age, Sex und Elastography\\]) scores.\n\nHigh-risk patients are allocated for a further CT\u002FMRI examination and an AFP examination to exclude HCC and receive another appointment for a hospital visit within 3 months.\n\nLow-risk patients receive an appointment in one year.",[18],"Other: Stratified survillance protocol",[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"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.",[9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"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.\n\nThey 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.",[15],[29,33,35],{"name":30,"affiliation":31,"role":32},"Jonel Trebicka, Prof. Dr. med.","Department of Internal Medicine B, University Hospital Muenster, Muenster, Germany","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":34,"role":32},"European Foundation for Study of Chronic Liver Failure, Barcelona, Spain",{"name":30,"affiliation":36,"role":32},"Department of Gastroenterology and Hepatology, Odense University Hospital, Denmark",[38,42],{"name":30,"role":39,"phone":40,"phoneExt":10,"email":41},"CONTACT","+49 02518359689","jonel.trebicka@ukmuenster.de",{"name":43,"role":39,"phone":44,"phoneExt":10,"email":45},"Josune Cabello Calleja, PhD","+34 688689194","josune.cabello@ukmuenster.de",[47],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"RECRUITING","Münster","North Rhine-Westphalia","48149","Germany","DE",{"type":55,"coordinates":56},"Point",[57,58],7.62571,51.96236,{"lat":58,"lon":57},[61,64,66],{"name":62,"role":39,"phone":63,"phoneExt":10,"email":41},"Jonel Profesor Dr. Dr. med Trebicka","+49 251 83-59689",{"name":65,"role":39,"phone":44,"phoneExt":10,"email":45},"Josune Cabello Calleja",{"name":67,"role":68,"phone":10,"phoneExt":10,"email":10},"Eduardo Dr. med. Cervantes Alvarez","SUB_INVESTIGATOR",{"type":32,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Prof. Dr. Jonel Trebicka","Head of department of internal medicine B, University professor, Principal investigator","100556323","prediction-of-decompensation-and-hcc-development-in-advanced-chronic-liver-disease-100556323",false,"NCT06523608","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","DETECT","Inclusion Criteria:\n\n* The patient admitted\u002Freferred to study center is hospitalized or is an outpatient with advanced chronic liver disease (based on the BAVENO criteria)\n\nExclusion Criteria:\n\n* Pregnancy\n* Age \\\u003C18\n* Evidence of current malignancy except for non-melanocytic skin cancer\n* 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).\n* Human Immunodeficiency Virus (HIV) positive patients.\n* Previous liver or other transplantation.\n* 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.\n* Physician's denial (e.g. the investigator considers that the patient will not follow the protocol scheduled).","ALL","18 Years",{"count":83,"type":84},600,"ESTIMATED","2 Years","OBSERVATIONAL","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.\n\nPatients in this study are randomly divided into two groups:\n\n* Control group: patients are examined according to the current clinical standard protocol (biannual follow-up).\n* Stratified surveillance program:\n\n  * High-risk patients will receive an appointment for a hospital visit every 3 months.\n  * 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.",[89,90,91,92],"Liver Diseases","Hepatocellular Carcinoma","Hepatocarcinoma","Advanced Chronic Liver Disease","2025-12-15",{"date":95,"type":96},"2025-12-22","ACTUAL",{"date":98,"type":96},"2024-09-01",{"date":100,"type":84},"2027-09",{"name":5,"class":6},1]