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临床试验/NCT07042308
NCT07042308招募中不适用

Natural History of Advanced Chronic Liver Diseases and Factors Associated With Hepatic Events - a Registry Study

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Incident hepatic events and liver-related mortality

研究概览

简要总结

This is a retrospective-prospective registry cohort study. Patients with advanced chronic liver disease (ACLD) will be prospectively invited to this study. The study follow-up duration will be 10 years. The primary outcome is incident hepatic events and liver-related mortality. Participants will undergo annual transient elastography examination.

详细描述

Chronic liver diseases (CLD) has burdened the global healthcare system throughout the years. Among all causes of CLD, chronic hepatitis B (CHB) is generally the commonest cause of CLD in the Asia-Pacific region but the prevalence is expected to decline due to effective antiviral treatment. Similarly, with the introduction of direct-acting antiviral (DAA), chronic hepatitis C (CHC) is now readily curable. On the other hand, an increasing trend is observed in metabolic dysfunction-associated steatotic liver disease (MASLD) and alcohol-related liver disease (ARLD) which is likely to change the landscape of CLD both in the region and worldwide.

Advanced chronic liver disease (ACLD) or cirrhosis is a final common pathway of all CLD and was the 9th and 15th leading cause of death in Southeast Asia (0.42 million deaths) in 2019 as reported by the World Health Organization (WHO) Global Health Estimates. It also significantly increases the risk of hepatocellular carcinoma (HCC). With its significant impact on morbidity and mortality, the prognosis of compensated and decompensated states differ drastically and the field is pushing forward ways to prevent hepatic decompensation in order to improve liver-related outcomes. Non-selective beta-blockers (NSBB) has been shown to reduce risk of hepatic decompensation in patients with compensated advanced chronic liver disease (cACLD) and concomitant clinically significant portal hypertension (CSPH). Some other drugs including angiotensin converting enzyme inhibitor (ACEI)/angiotensin-receptor blocker (ARB), statin etc. have been shown in retrospective studies to reduce risk of hepatic decompensation but more evidence is required to draw conclusive interpretation.

Apart from medications, non-invasive tests (NIT), including liver stiffness measurement (LSM) and spleen stiffness measurement (SSM) from vibration-controlled transient elastography (VCTE) help prognosticate chronic liver diseases. Yet more validation is required on certain conditions such as in patients with obesity as well as HCC. Biomarkers are also under the spotlights for risk prediction but are yet to reach the stage for widespread clinical practice. Hence these areas deserve further studies.

Hong Kong is an area endemic for chronic hepatitis B as well as expected for an increase with MASLD and ARLD. There has not been an established registry to capture these ACLD patients for systematic monitoring and analysis. Thus, a registry for ACLD is imperative.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 or above
  • Known ACLD, defined by:
  • LSM > 10kPa or
  • Clinical cirrhosis, suggested by
  • ultrasonography of the hepatobiliary system shows features of cirrhosis (e.g. shrunken and nodular liver) and portal hypertension (e.g. dilated portal vein, portal-systemic collaterals or varices, splenomegaly, ascites).
  • Oesophagogastroduodenoscopy (OGD) shows presence of oesophageal varices (OV) and/or gastric varices (GV) and/or portal hypertensive gastropathy.

排除标准

  • Current or past history of hepatocellular carcinoma (HCC)
  • History of liver transplantation
  • Asplenism or history of splenectomy
  • Serious medical illness with limited life expectancy of less than 6 months
  • Pregnancy
  • Unable to obtain or refusal of informed consent from patient

结局指标

主要结局

Incident hepatic events and liver-related mortality

时间窗: 10 years

Incident hepatic events (including ascites, variceal bleeding and overt hepatic encephalopathy) and liver-related mortality

次要结局

  • Incidence rate of each hepatic event(10 years)
  • Incidence rate of hepatocellular carcinoma(10 years)
  • Changes in Child-Pugh and Model for End-stage Liver Disease scores(10 years)
  • Change in liver and spleen stiffness(10 years)
  • Exploratory outcome on identification of novel biomarkers(10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jimmy Che-To Lai

Assistant Professor (Clinical)

Chinese University of Hong Kong

研究点 (1)

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