Prediction of Decompensation and HCC Development in Patients With Advanced Chronic Liver Disease by the PLEASE and M10S20 Algorithms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
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:
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Control group: patients are examined according to the current clinical standard protocol (biannual follow-up).
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Stratified surveillance program:
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High-risk patients will receive an appointment for a hospital visit every 3 months.
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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.
详细描述
Patients who are hospitalized with advanced chronic liver disease are randomly divided into two groups.
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient admitted/referred to study center is hospitalized or is an outpatient with advanced chronic liver disease (based on the BAVENO criteria)
排除标准
- •Pregnancy
- •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).
结局指标
主要结局
Mortality
时间窗: 2 years
All-cause mortality rate and liver-related mortality rate
Liver transplantation
时间窗: 2 years
Incidence of liver transplantation during follow-up period and time until liver transplantation.
次要结局
- Acute liver decompensations(2 years)
- Analysis of cost-effectiveness of the new algorithm compared to the routine follow-up(2 years)
- Influence of circulating immune cells in HCC development and progression(2 years)
- De novo HCC(2 years)
- Therapy in patients who develop HCC during follow-up(2 years)
- Analysis of proteome and metabolome in patients included into the study(2 years)
- Influence of transcriptome and metagenome in HCC development and progression(2 years)
- Analysis of intestinal and circulating microbiome in patients included into the study(2 years)
研究者
Prof. Dr. Jonel Trebicka
Head of department of internal medicine B, University professor, Principal investigator
University Hospital Muenster