Boramae Hospital Liver Cirrhosis Patient Cohort Study

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943318
• Other study ID #: BRM_LC_Cohort
• Status: Completed
• Start date: January 2013
• Est. completion date: May 2022

Study information

• Verified date: April 2023
• Source: Seoul National University Boramae Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Age =19years old Proven cirrhosis

• No previous hepatocellular carcinoma (treated or not)

• Signed informed consent

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Fibrosis
• Hepatocellular Carcinoma
• Liver Cirrhosis

Intervention

Procedure:
• Liver biopsy
Histologic evaluation

Device:
• Hepatic venous pressure gradient (HVPG) measurement
Hepatic venous pressure gradient (HVPG) measurement

Locations

Country	Name	City	State
Korea, Republic of	SNU-SMG Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Boramae Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Dam Fialla A, Schaffalitzky de Muckadell OB, Touborg Lassen A. Incidence, etiology and mortality of cirrhosis: a population-based cohort study. Scand J Gastroenterol. 2012 Jun;47(6):702-9. doi: 10.3109/00365521.2012.661759. Epub 2012 Mar 19. — View Citation

Reiberger T, Ferlitsch A, Payer BA, Pinter M, Homoncik M, Peck-Radosavljevic M; Vienna Hepatic Hemodynamic Lab. Non-selective beta-blockers improve the correlation of liver stiffness and portal pressure in advanced cirrhosis. J Gastroenterol. 2012 May;47(5):561-8. doi: 10.1007/s00535-011-0517-4. Epub 2011 Dec 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver-related outcome: Decompensated liver cirrhosis (ascites, variceal bleeding, hepatic encepahlopathy), occurence of hepatocellular carcinoma	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	5 years
Secondary	Mortality	overall mortality - whatever the cause of death	5 years
Secondary	Liver-related mortality	cumulative incidence of liver-related deaths	5 years