- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07651683
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.
Přehled studie
Postavení
Detailní popis
- 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.
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).
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.
- 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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
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Guangdong
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Guangzhou, Guangdong, Čína, 510000
- Third Affiliated Hospital, Sun Yat-Sen University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Age: Patients aged 18 to 75 years.
- Diagnosis of Cirrhosis: Confirmed diagnosis of liver cirrhosis based on clinical, biochemical, hematological, radiological (CT/MRI/Ultrasound), or histological evidence.
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.
- Intervention/Management: Currently receiving or initiating nucleos(t)ide analogue (NA) antiviral therapy (for HBV cohort), or having initiated alcohol abstinence (for Alcohol cohort).
- Index Decompensation: Presenting with esophagogastric variceal bleeding (EVB) as the first and only decompensating event at enrollment.
Exclusion Criteria:
- 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).
- 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).
- Liver Function Status: Child-Turcotte-Pugh (CTP) score > 12. Malignancy: Diagnosis of hepatocellular carcinoma (HCC) or other extrahepatic malignancies.
- Organ Failure: Severe dysfunction or failure of extrahepatic organs (e.g., severe cardiac, respiratory, or renal failure not attributed to liver disease).
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Rate of recompensation
Časové okno: 1 year
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1 year
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Bin Wu, Third Affiliated Hospital, Sun Yat-Sen University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
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Popis plánu IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- CSR
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