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临床试验/NCT01943318
NCT01943318已完成不适用

Prospective Cohort Study to Evaluate Long-term Outcomes in Patients With Liver Cirrhosis of Boramae Hospital

Seoul National University Boramae Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
1
主要终点
Liver-related outcome: Decompensated liver cirrhosis (ascites, variceal bleeding, hepatic encepahlopathy), occurence of hepatocellular carcinoma

研究概览

简要总结

Liver cirrhosis represents a worldwide health problem and is a major cause of mortality. Cirrhosis is the common end for chronic alcohol abuse and hepatitis C and B virus infections. Patients who have cirrhosis have varying degrees of compensated liver function, and clinicians need to differentiate between those who have stable, compensated cirrhosis and those who have decompensated cirrhosis. It is shown various complications: portal hypertension, hepatocellular carcinoma, hepato-renal syndrome, etc.

Thus, it is important to have this information to manage disease and determine specific therapy. However, register-based studies in have not been reported in Korea.

The goal of this study is to describe the natural history of a large number of patients with liver cirrhosis prospectively followed, and to identify predictors of the occurrence of Hepatocellular carcinoma.

详细描述

The investigators are planning to recruit patients with liver cirrhosis, and collect the baseline clinical laboratory data. Biological tests, endoscopy,liver ultrasonography (including ARFI) and hepatic venous pressure gradient measurements will be performed if not done within 90 days prior to inclusion. During this visit, 20 ml of blood will be collected for freezing and storage of serum and plasma, and constitution of a DNA library.

Monitoring: Patients will have regular surveillance with blood test, liver ultrasonography and medical consultation at least every 6 months, periodic assessment of esophageal, gastric varices and portal hypertensive gastropathy (every 1 year) and prevention of their rupture if any. An additional blood sampling of 20 ml will be taken at baseline and every year in order to perform whole blood, serum, plasma, peripheral blood mononuclear cells and DNA libraries; Data will be standardized and centralized in a single database.

And alcoholic liver cirrhosis patients will undergo liver biopsy for polymerase chain reaction, western blot, immunohistochemistry and RNA analysis.

After measurement of hepatic venous pressure gradient and liver stiffness at baseline a non-selective beta-blocker (NSBB,carvedilol) was initiated and increased stepwise (weekly) until the systolic blood pressure remained at>100 mmHg and the heart rate was not <60. The maximum target dose for carvedilol 25 mg/day. The hepatic venous pressure gradient response to NSBB was again assessed 6 weeks after the intake of carvedilol. A hemodynamic response to NSBB treatment was defined as a reduction in hepatic venous pressure gradient >=20% compared to baseline or to an absolute value <=12 mmHg. Compliance with therapy was monitored by monitoring of heart rate and blood pressure during clinical visits.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥19years old Proven cirrhosis
  • No previous hepatocellular carcinoma (treated or not)
  • Signed informed consent

排除标准

  • serious associated short-term life threatening disease (except associated HIV viral infection and the liver disease itself)
  • liver focal lesion suggestive of hepatocellular carcinoma
  • patient under guardianship
  • pregnant women
  • inability to regular monitoring, for whatever reason

结局指标

主要结局

Liver-related outcome: Decompensated liver cirrhosis (ascites, variceal bleeding, hepatic encepahlopathy), occurence of hepatocellular carcinoma

时间窗: 5 years

Cumulative incidence within 5 years Laboratory Tests: Albumin, Total bilirubin, prothrombin time, Platelet Hepatic venous pressure gradient measurement Imaging study like Liver CT or Liver ultrasonography Endoscopy for varix evaluation

次要结局

  • Mortality(5 years)
  • Liver-related mortality(5 years)

研究者

发起方
Seoul National University Boramae Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Won Kim

MD, PhD

Seoul National University Boramae Hospital

研究点 (1)

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