Boramae Hospital Liver Cirrhosis Patient Cohort Study
- Conditions
- Liver CirrhosisHepatocellular Carcinoma
- Registration Number
- NCT01943318
- Lead Sponsor
- Seoul National University Boramae Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- Age ≥19years old Proven cirrhosis
- No previous hepatocellular carcinoma (treated or not)
- Signed informed consent
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Liver-related outcome: Decompensated liver cirrhosis (ascites, variceal bleeding, hepatic encepahlopathy), occurence of hepatocellular carcinoma 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
- Secondary Outcome Measures
Name Time Method Liver-related mortality 5 years cumulative incidence of liver-related deaths
Mortality 5 years overall mortality - whatever the cause of death
Trial Locations
- Locations (1)
SNU-SMG Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
SNU-SMG Boramae Medical Center🇰🇷Seoul, Korea, Republic of