Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Clinical Characteristics of Recompensation

10 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

  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 de estudio

De observación

Inscripción (Estimado)

300

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Rate of recompensation
Periodo de tiempo: 1 year
1 year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: Bin Wu, Third Affiliated Hospital, Sun Yat-Sen University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

31 de marzo de 2026

Finalización primaria (Estimado)

1 de marzo de 2027

Finalización del estudio (Estimado)

31 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

30 de marzo de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de junio de 2026

Publicado por primera vez (Actual)

16 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

10 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

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

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir