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

Not yet recruiting

• Conditions: Decompensated Cirrhosis; Hepatitis B Virus (HBV) Infection; Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD); Alcohol-Related Liver Disease; Portal Hypertension; Recompensation

• Registration Number: NCT07087041
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-04
• Study Start: 2025-07-15
• Study First Submitted QC: 2025-07-23
• Last Update Submitted: 2025-07-23
• Study First Posted: 2025-07-25
• Last Update Posted: 2025-07-25
• Primary Completion: 2028-10-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 735

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of non-invasive models based on spleen stiffness in predicting Recompensation	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Discrimination, calibration, and stability of the prediction model	2 years	This outcome assesses the performance of the prediction model developed to identify recompensation and stable recompensation in people with decompensated cirrhosis.
Predictive accuracy of spleen stiffness in identifying recompensation and stable recompensation	2 years	This outcome evaluates the predictive accuracy of spleen stiffness in identifying recompensation and stable recompensation among participants with decompensated cirrhosis.
Predictive accuracy of liver stiffness in identifying recompensation and stable recompensation	2 years	This outcome evaluates the predictive accuracy of liver stiffness in identifying recompensation and stable recompensation among participants with decompensated cirrhosis.
Predictive accuracy of platelets in identifying recompensation and stable recompensation	2 years	This outcome evaluates the predictive accuracy of platelet count in identifying recompensation and stable recompensation among participants with decompensated cirrhosis.
Cumulative incidence of recompensation by etiology	2 years	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.
Cumulative incidence of stable recompensation by etiology	2 years	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.
Cumulative incidence of further decompensation by etiology	2 years	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.
Cumulative incidence of liver-related composite endpoints by etiology	2 years	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.

Trial Locations

Locations (28)

Beijing Ditan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing You'an Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

Mengchao Hepatobiliary Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

The Second Hospital of Lanzhou University; 🇨🇳 Lanzhou, Gansu, China

Foshan Traditional Chinese Medicine Hospital; 🇨🇳 Foshan, Guangdong, China

The First People's Hospital of Foshan; 🇨🇳 Foshan, Guangdong, China

Guangzhou Eighth People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Provincial Hospital of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China

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