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

Официальное название

Prediction of Recompensation and Stable Recompensation in Patients With Decompensated Cirrhosis Using Spleen Stiffness Combined With Non-Invasive Markers: A Prospective, Observational, Multicenter Study

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Accuracy of non-invasive models based on spleen stiffness in predicting Recompensation [Срок оценки: 2 years]

Вторичные конечные точки (8)

• Discrimination, calibration, and stability of the prediction model [Срок оценки: 2 years]
• Predictive accuracy of spleen stiffness in identifying recompensation and stable recompensation [Срок оценки: 2 years]
• Predictive accuracy of liver stiffness in identifying recompensation and stable recompensation [Срок оценки: 2 years]
• Predictive accuracy of platelets in identifying recompensation and stable recompensation [Срок оценки: 2 years]
• Cumulative incidence of recompensation by etiology [Срок оценки: 2 years]
• Cumulative incidence of stable recompensation by etiology [Срок оценки: 2 years]
• Cumulative incidence of further decompensation by etiology [Срок оценки: 2 years]
• Cumulative incidence of liver-related composite endpoints by etiology [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 28 центров

• Beijing Ditan Hospital, Capital Medical University — Пекин
• Beijing Friendship Hospital, Capital Medical University — Пекин
• Beijing You'an Hospital, Capital Medical University — Пекин
• The First Affiliated Hospital of Fujian Medical University — Фучжоу
• Mengchao Hepatobiliary Hospital of Fujian Medical University — Фучжоу
• The Second Hospital of Lanzhou University — Lanzhou
• Foshan Traditional Chinese Medicine Hospital — Foshan
• The First People's Hospital of Foshan — Foshan
• … и ещё 20 центров

Идентификаторы

NCT: NCT07087041 · 2025-P2-244-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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