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

N/ANot Yet RecruitingNCT07087041

Beijing Friendship Hospital735 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

735

Conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (28)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing You'an Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, China

Outcomes

Primary Outcomes

Accuracy of non-invasive models based on spleen stiffness in predicting Recompensation

The primary outcome of this study is the accuracy of a non-invasive prediction model based on spleen stiffness and routine laboratory markers in identifying recompensation and stable recompensation in individuals with decompensated cirrhosis.

Time frame: 2 years

Secondary Outcomes

Discrimination, calibration, and stability of the prediction model

This outcome assesses the performance of the prediction model developed to identify recompensation and stable recompensation in people with decompensated cirrhosis.

Time frame: 2 years

Predictive accuracy of spleen stiffness in identifying recompensation and stable recompensation

This outcome evaluates the predictive accuracy of spleen stiffness in identifying recompensation and stable recompensation among participants with decompensated cirrhosis.

Time frame: 2 years

Predictive accuracy of liver stiffness in identifying recompensation and stable recompensation

This outcome evaluates the predictive accuracy of liver stiffness in identifying recompensation and stable recompensation among participants with decompensated cirrhosis.

Time frame: 2 years

Predictive accuracy of platelets in identifying recompensation and stable recompensation

This outcome evaluates the predictive accuracy of platelet count in identifying recompensation and stable recompensation among participants with decompensated cirrhosis.

Time frame: 2 years

Cumulative incidence of recompensation by etiology

This outcome measures the 2-year cumulative incidence of recompensation among participants with decompensated cirrhosis, stratified by the underlying cause of liver disease (etiology). Recompensation is defined as the effective control or removal of the primary cause of liver disease, resolution of ascites and hepatic encephalopathy with no episodes of variceal bleeding for at least 12 months, and improvement in liver function indicated by a Child-Pugh classification of Class A and/or a MELD score below 10.

Time frame: 2 years

Cumulative incidence of stable recompensation by etiology

This outcome measures the 2-year cumulative incidence of stable recompensation in participants with decompensated cirrhosis, stratified by liver disease etiology. Stable recompensation is defined as achieving recompensation and maintaining that status without further decompensated events for at least one additional year.

Time frame: 2 years

Cumulative incidence of further decompensation by etiology

This outcome evaluates the 2-year cumulative incidence of further decompensation among participants with decompensated cirrhosis, stratified by the underlying etiology of liver disease. Further decompensation is defined as the occurrence of new or worsening clinical events such as ascites, hepatic encephalopathy, or variceal bleeding after initial enrollment.

Time frame: 2 years

Cumulative incidence of liver-related composite endpoints by etiology

This outcome assesses the 2-year cumulative incidence of liver-related composite endpoints among participants with decompensated cirrhosis, stratified by liver disease etiology.Liver-related composite endpoints include the first occurrence of any of the following events: Further hepatic decompensation (e.g., ascites, variceal bleeding, hepatic encephalopathy); Hepatocellular carcinoma (HCC); Liver transplantation; Liver-related death.

Time frame: 2 years

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

Overview

Conditions

Eligibility

Locations (28)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts