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Clinical Characteristics of Recompensation

10 giugno 2026 aggiornato da: Yifei Huang, Third Affiliated Hospital, Sun Yat-Sen University

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.

Panoramica dello studio

Descrizione dettagliata

  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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

300

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Rate of recompensation
Lasso di tempo: 1 year
1 year

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Cattedra di studio: Bin Wu, Third Affiliated Hospital, Sun Yat-Sen University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

31 marzo 2026

Completamento primario (Stimato)

1 marzo 2027

Completamento dello studio (Stimato)

31 dicembre 2027

Date di iscrizione allo studio

Primo inviato

30 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

10 giugno 2026

Primo Inserito (Effettivo)

16 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR)

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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