A Study to Predict Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness and Simple Blood Tests (LEAD-2)

Capital Medical University

Status

Not yet enrolling

Conditions

Portal Hypertension

Decompensated Cirrhosis

Hepatitis B Virus (HBV) Infection

Alcohol-Related Liver Disease

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Recompensation

Study type

Observational

Funder types

Other

Identifiers

NCT07087041

2025-P2-244-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

735 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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