Boramae Hospital Liver Cirrhosis Patient Cohort Study

April 11, 2023 updated by: Won Kim, Seoul National University Boramae Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Seoul National University Boramae hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Alcohol

Alcoholic Liver Cirrhosis

Participants will undergo liver biopsy. Participants will undergo hepatic venous pressure gradient measurement.
Procedure: Liver biopsy
Histologic evaluation
Device: Hepatic venous pressure gradient (HVPG) measurement
Hepatic venous pressure gradient (HVPG) measurement
Hepatitis B virus
Hepatitis B virus (HBV) Liver Cirrhosis
Procedure: Liver biopsy
Histologic evaluation
Device: Hepatic venous pressure gradient (HVPG) measurement
Hepatic venous pressure gradient (HVPG) measurement
Hepatitis C virus
Hepatitis C virus (HCV) Liver Cirrhosis
Procedure: Liver biopsy
Histologic evaluation
Device: Hepatic venous pressure gradient (HVPG) measurement
Hepatic venous pressure gradient (HVPG) measurement
Autoimmune
Autoimmune Cirrhosis
Procedure: Liver biopsy
Histologic evaluation
Device: Hepatic venous pressure gradient (HVPG) measurement
Hepatic venous pressure gradient (HVPG) measurement
Biliary
Primary or secondary biliary cirrhosis
Procedure: Liver biopsy
Histologic evaluation
Device: Hepatic venous pressure gradient (HVPG) measurement
Hepatic venous pressure gradient (HVPG) measurement
Toxic
Medication related cirrhosis
Procedure: Liver biopsy
Histologic evaluation
Device: Hepatic venous pressure gradient (HVPG) measurement
Hepatic venous pressure gradient (HVPG) measurement
Others
Hepatic venous pressure gradient (HVPG) measurement
Procedure: Liver biopsy
Histologic evaluation
Device: Hepatic venous pressure gradient (HVPG) measurement
Hepatic venous pressure gradient (HVPG) measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver-related outcome: Decompensated liver cirrhosis (ascites, variceal bleeding, hepatic encepahlopathy), occurence of hepatocellular carcinoma
Time Frame: 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
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 5 years
overall mortality - whatever the cause of death
5 years
Liver-related mortality
Time Frame: 5 years
cumulative incidence of liver-related deaths
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Boramae Hospital

Investigators

  • Principal Investigator: Won Kim, MD, Boramae Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

August 22, 2013

First Submitted That Met QC Criteria

September 11, 2013

First Posted (Estimate)

September 16, 2013

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRM_LC_Cohort

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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