Boramae Hospital Liver Cirrhosis Patient Cohort Study
Prospective Cohort Study to Evaluate Long-term Outcomes in Patients With Liver Cirrhosis of Boramae Hospital
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 22, 2013
CompletedFirst Posted
Study publicly available on registry
September 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedApril 12, 2023
April 1, 2023
9.3 years
August 22, 2013
April 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Mortality
5 years
Liver-related mortality
5 years
Study Arms (7)
Alcohol
Alcoholic Liver Cirrhosis Participants will undergo liver biopsy. Participants will undergo hepatic venous pressure gradient measurement.
Hepatitis B virus
Hepatitis B virus (HBV) Liver Cirrhosis
Hepatitis C virus
Hepatitis C virus (HCV) Liver Cirrhosis
Autoimmune
Autoimmune Cirrhosis
Biliary
Primary or secondary biliary cirrhosis
Toxic
Medication related cirrhosis
Others
Hepatic venous pressure gradient (HVPG) measurement
Interventions
Histologic evaluation
Hepatic venous pressure gradient (HVPG) measurement
Eligibility Criteria
Seoul National University Boramae hospital
You may qualify if:
- Age ≥19years old Proven cirrhosis
- No previous hepatocellular carcinoma (treated or not)
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SNU-SMG Boramae Medical Center
Seoul, 156707, South Korea
Related Publications (4)
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.
PMID: 22428859BACKGROUNDReiberger 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.
PMID: 22170417BACKGROUNDCho Y, Choi YI, Oh S, Han J, Joo SK, Lee DH, Jung YJ, Kim BG, Lee KL, Kim W. Point shear wave elastography predicts fibrosis severity and steatohepatitis in alcohol-related liver disease. Hepatol Int. 2020 Mar;14(2):270-280. doi: 10.1007/s12072-019-10009-w. Epub 2019 Dec 19.
PMID: 31858403DERIVEDKim HY, So YH, Kim W, Ahn DW, Jung YJ, Woo H, Kim D, Kim MY, Baik SK. Non-invasive response prediction in prophylactic carvedilol therapy for cirrhotic patients with esophageal varices. J Hepatol. 2019 Mar;70(3):412-422. doi: 10.1016/j.jhep.2018.10.018. Epub 2018 Oct 31.
PMID: 30389550DERIVED
Biospecimen
At enrollement, 20 ml of blood will be collected for freezing and storage of serum and plasma, and constitution of a DNA library
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Won Kim, MD
Boramae Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 20 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
August 22, 2013
First Posted
September 16, 2013
Study Start
January 1, 2013
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
April 12, 2023
Record last verified: 2023-04