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.

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.

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

Adults aged 18 to 75 years with decompensated cirrhosis who are receiving and maintaining effective treatment for the underlying cause of liver disease. The first decompensation event must be clinically significant ascites and/or variceal bleeding. Participants must have either experienced their first decompensation within the past 12 months or remained free from new decompensation events during the past 12 months.

The individual participant data to be shared include de-identified demographic information, clinical characteristics, laboratory test results (including spleen stiffness, liver stiffness, platelet counts, and other routine blood tests), treatment details, and clinical outcomes related to recompensation and stable recompensation.

Individual participant data (IPD) and supporting documentation will be available beginning 6 months after publication of the primary study results.

Qualified researchers affiliated with academic or medical institutions will be able to request access to the de-identified individual participant data (IPD) and supporting documents (such as study protocol and statistical analysis plan).

All requests will be reviewed and approved by the study steering committee.