An observational study in Liver Cirrhosis and Hepatocellular Carcinoma, sponsored by Seoul National University Boramae Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by Seoul National University Boramae Hospital · Observational
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.
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.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's enrollment of 500 is above the median of 171 across 526 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Seoul National University Boramae Hospital is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
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Seoul National University Boramae hospital
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Alcoholic Liver Cirrhosis Participants will undergo liver biopsy. Participants will undergo hepatic venous pressure gradient measurement.
Procedure: Liver biopsy · Device: Hepatic venous pressure gradient (HVPG) measurement
Hepatitis B virus (HBV) Liver Cirrhosis
Procedure: Liver biopsy · Device: Hepatic venous pressure gradient (HVPG) measurement
Hepatitis C virus (HCV) Liver Cirrhosis
Procedure: Liver biopsy · Device: Hepatic venous pressure gradient (HVPG) measurement
Autoimmune Cirrhosis
Procedure: Liver biopsy · Device: Hepatic venous pressure gradient (HVPG) measurement
Primary or secondary biliary cirrhosis
Procedure: Liver biopsy · Device: Hepatic venous pressure gradient (HVPG) measurement
Medication related cirrhosis
Procedure: Liver biopsy · Device: Hepatic venous pressure gradient (HVPG) measurement
Hepatic venous pressure gradient (HVPG) measurement
Procedure: Liver biopsy · Device: Hepatic venous pressure gradient (HVPG) measurement
Histologic evaluation
Hepatic venous pressure gradient (HVPG) measurement
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
Time frame: 5 years
Mortality
overall mortality - whatever the cause of death
Time frame: 5 years
Liver-related mortality
cumulative incidence of liver-related deaths
Time frame: 5 years
Plan to share: Undecided
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Seoul National University Boramae Hospital