A Study to Predict Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness and Simple Blood Tests
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Decompensated Cirrhosis, Hepatitis B Virus (HBV) Infection, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Alcohol-Related Liver Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prediction of Recompensation and Stable Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness Combined With Non-Invasive Markers: A Prospective, Observational, Multicenter Study
Overview
The goal of this observational study is to learn if spleen stiffness and other non-invasive markers can help predict recompensation in people with decompensated cirrhosis who are receiving effective treatment for the cause of their liver disease. The main questions it aims to answer are: * Can spleen stiffness and blood test results predict who will get better and stay better after cirrhosis becomes worse? * What are the features of people who recover after decompensation? Participants will: * Be people with decompensated cirrhosis who are already getting effective treatment (such as antiviral therapy or alcohol abstinence) * Be followed over time to check if they remain stable or have more liver problems * Have non-invasive tests done, including spleen stiffness measurement and blood tests Researchers will track how many participants recover and stay recovered over time, and use that information to build a tool to help predict outcomes in others with cirrhosis.
Detailed description
This is a prospective, observational, multicenter study designed to follow adults with decompensated cirrhosis who are receiving effective treatment for the underlying cause of their liver disease, such as antiviral therapy, alcohol abstinence, or metabolic management. The study is aiming to understand how these patients recover after treatment; Identify how often they achieve recompensation and stable recommendation; Develop a non-invasive model using spleen stiffness and other markers to predict who is more likely to improve.
Participants will be grouped based on whether they have had decompensation within the past 12 months. Researchers will regularly collect clinical data, spleen stiffness measurements, and lab tests, to develop and validate a model that predicts recompensation and stable recompensation. The study will also assess the cumulative incidence of clinical events (e.g., further decompensation, hepatocellular carcinoma, liver transplantation, and death) over a two-year follow-up period. Predictive accuracy, model calibration, and discrimination will be evaluated using standard statistical methods, including competing risk models and AUROC analysis.
Primary outcome measures
- Accuracy of non-invasive models based on spleen stiffness in predicting Recompensation [Time frame: 2 years]
Secondary outcome measures (8)
- Discrimination, calibration, and stability of the prediction model [Time frame: 2 years]
- Predictive accuracy of spleen stiffness in identifying recompensation and stable recompensation [Time frame: 2 years]
- Predictive accuracy of liver stiffness in identifying recompensation and stable recompensation [Time frame: 2 years]
- Predictive accuracy of platelets in identifying recompensation and stable recompensation [Time frame: 2 years]
- Cumulative incidence of recompensation by etiology [Time frame: 2 years]
- Cumulative incidence of stable recompensation by etiology [Time frame: 2 years]
- Cumulative incidence of further decompensation by etiology [Time frame: 2 years]
- Cumulative incidence of liver-related composite endpoints by etiology [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Male or female, aged 18 to 75 years (inclusive)
- Clinically diagnosed decompensated cirrhosis
- First decompensated event occurred within 12 months of screening, or no decompensated events in the past 12 months despite a history of decompensation
- Received effective etiological treatment per guidelines:
- For HBV: Sustained antiviral suppression
- For alcohol-related liver disease: Sustained abstinence for ≥2 months
- For MAFLD-related cirrhosis: Improved liver function after lifestyle/ metabolic intervention
Exclusion criteria
- Missing data on first decompensated event
- Prior orthotopic liver transplantation or TIPS
- Prior splenectomy, splenic embolization, or other shunt surgery
- History or current diagnosis of hepatocellular carcinoma
- Acute variceal bleeding within the last 4 weeks or unstable condition
- Uncontrolled moderate-to-severe ascites
- Cholestatic cirrhosis; untreated chronic liver diseases; non-cirrhotic portal hypertension; vascular liver diseases (e.g., Budd-Chiari syndrome)
- Acute or chronic portal vein thrombosis
- Severe comorbidities of heart, lung, kidney, brain, hematologic, or psychiatric systems
- Other systemic malignancies (except cured cases)
- Pregnant or breastfeeding women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 28 centers
- Beijing Ditan Hospital, Capital Medical University — Beijing
- Beijing Friendship Hospital, Capital Medical University — Beijing
- Beijing You'an Hospital, Capital Medical University — Beijing
- The First Affiliated Hospital of Fujian Medical University — Fuzhou
- Mengchao Hepatobiliary Hospital of Fujian Medical University — Fuzhou
- The Second Hospital of Lanzhou University — Lanzhou
- Foshan Traditional Chinese Medicine Hospital — Foshan
- The First People's Hospital of Foshan — Foshan
- … and 20 more centers
Identifiers
NCT: NCT07087041 · 2025-P2-244-01