Clinical Characteristics of Recompensation

Clinical Characteristics and Outcomes of Recompensation in Decompensated Cirrhosis

Recompensation in decompensated liver cirrhosis is an emerging clinical endpoint; however, standardized criteria and long-term prognostic data are currently lacking. This retrospective study aims to address these gaps by analyzing a cohort of patients with HBV-related and alcohol-related cirrhosis.

This retrospective cohort study aims to validate established recompensation criteria and propose new standards for defining stable liver function.

Additionally, the study will characterize the natural history of recompensated patients by tracking the duration of recompensation, incidence of hepatocellular carcinoma, and liver-related mortality. Statistical analysis will be performed to identify baseline predictors for achieving recompensation and to determine risk factors for subsequent re-decompensation events.

Identify Predictors: Analyze baseline characteristics to identify independent predictors for achieving recompensation.

Evaluate Risks: Investigate risk factors associated with re-decompensation in patients who have successfully achieved recompensation.

Study Overview

• Status: Active, not recruiting
• Conditions: Cirrhosis; HBV (Hepatitis B Virus); Alcohol Related Liver Disease; Recompensation

Detailed Description

1. Background and Epidemiology Cirrhosis remains a leading cause of morbidity and global mortality, with a disproportionately high burden in the Asia-Pacific region. According to WHO data, the Asia-Pacific region accounts for nearly half of global cirrhosis-related deaths, driven primarily by Hepatitis B virus (HBV) infection and alcohol-associated liver disease (ALD). While antiviral therapies (e.g., nucleoside/nucleotide analogues) for HBV and abstinence for ALD have been shown to slow disease progression and improve survival, the clinical trajectory of patients who present with decompensated cirrhosis has traditionally been considered irreversible.

2. The Concept of Recompensation

   Historically, decompensated cirrhosis was viewed as a terminal stage with a median survival of 2-4 years. However, emerging evidence suggests that effective etiological treatment can lead to "recompensation"-a distinct clinical state characterized by the resolution of decompensation events and functional liver recovery. The Baveno VII consensus provided the first standardized definition of recompensation, requiring:

   Removal, suppression, or cure of the primary etiology; Resolution of ascites, hepatic encephalopathy, and variceal bleeding for at least 1 year without specific supportive treatments (e.g., diuretics); Sustained improvement in liver function (though specific cut-off values for parameters like albumin and INR remain to be fully defined).

3. Current Evidence and Knowledge Gaps Recent studies have begun to validate this concept. Research in HBV-related cirrhosis (e.g., Wang et al., Deng et al.) indicates that 50-80% of treated patients may achieve recompensation, correlating with reduced incidences of hepatocellular carcinoma (HCC) and improved survival comparable to compensated patients. Similarly, limited data in ALD (Benedikt et al.) suggest that recompensation is associated with hemodynamic improvements and reduced mortality.

   Despite these advances, significant gaps remain:

   Definition Ambiguity: The "stable liver function" criterion in Baveno VII lacks quantitative precision.

   Etiological Scope: Most data focus on HBV, with insufficient comparative data for ALD.

   Durability: The long-term stability of the recompensated state and the risk factors for "redecompensation" are poorly understood.

4. Study Objectives This retrospective cohort study aims to validate established recompensation criteria and propose new standards for defining stable liver function.

Additionally, the study will characterize the natural history of recompensated patients by tracking the duration of recompensation, incidence of hepatocellular carcinoma, and liver-related mortality. Statistical analysis will be performed to identify baseline predictors for achieving recompensation and to determine risk factors for subsequent re-decompensation events.

Identify Predictors: Analyze baseline characteristics to identify independent predictors for achieving recompensation.

Evaluate Risks: Investigate risk factors associated with re-decompensation in patients who have successfully achieved recompensation.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Third Affiliated Hospital, Sun Yat-Sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatitis B virus (HBV)-related cirrhosis and alcohol-associated cirrhosis managed at Third Affiliated Hospital, Sun Yat-Sen University between March 2022 and December 2024 were retrospectively identified for inclusion.

Description

Inclusion Criteria:

1. Age: Patients aged 18 to 75 years.
2. Diagnosis of Cirrhosis: Confirmed diagnosis of liver cirrhosis based on clinical, biochemical, hematological, radiological (CT/MRI/Ultrasound), or histological evidence.

3. Specific Etiology (Must meet one of the following):

   HBV-related: Documented Hepatitis B surface antigen (HBsAg) positivity. Alcohol-related: Documented history of significant alcohol intake or recent heavy alcohol consumption (within the past 2 weeks) combined with HBsAg negativity and radiological evidence of hepatic steatosis.

4. Intervention/Management: Currently receiving or initiating nucleos(t)ide analogue (NA) antiviral therapy (for HBV cohort), or having initiated alcohol abstinence (for Alcohol cohort).
5. Index Decompensation: Presenting with esophagogastric variceal bleeding (EVB) as the first and only decompensating event at enrollment.

Exclusion Criteria:

1. Concomitant Liver Disease: Evidence of other coexisting etiologies of chronic liver disease (e.g., Hepatitis C virus infection, autoimmune liver disease, drug-induced liver injury, or parasitic liver disease).
2. Prior Decompensation: Current presence or prior history of other decompensation events, specifically moderate-to-severe ascites (grade 2 or 3), hepatic encephalopathy (HE), hepatorenal syndrome (HRS), or hepatopulmonary syndrome (HPS).
3. Liver Function Status: Child-Turcotte-Pugh (CTP) score > 12. Malignancy: Diagnosis of hepatocellular carcinoma (HCC) or other extrahepatic malignancies.
4. Organ Failure: Severe dysfunction or failure of extrahepatic organs (e.g., severe cardiac, respiratory, or renal failure not attributed to liver disease).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HBV-related cirrhosis cohort; Patients with HBV-related cirrhosis managed at Third Affiliated Hospital, Sun Yat-Sen University between March 2022 and December 2024 were retrospectively identified for inclusion.
alcohol-related cirrhosis cohort; Patients with alcohol-associated cirrhosis managed at Third Affiliated Hospital, Sun Yat-Sen University between March 2022 and December 2024 were retrospectively identified for inclusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of recompensation	1 year

Collaborators and Investigators

• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
• Investigators: Study Chair: Bin Wu, Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Cirrhosis; Hepatitis B virus; Alcohol-related liver disease; Recompensation
• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis; Pathological Conditions, Signs and Symptoms; Fibrosis; Hepatitis B
• Other Study ID Numbers: ZSSYXHNK2601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No