A Study to Predict Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness and Simple Blood Tests

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