Boramae Liver Cirrhosis Cohort Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Seoul National University Boramae Hospital
Sponsor:
Information provided by (Responsible Party):
Hwi Young Kim, MD.PhD, Seoul National University Boramae Hospital
ClinicalTrials.gov Identifier:
NCT01943318
First received: August 22, 2013
Last updated: February 9, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Liver Cirrhosis
Hepatocellular Carcinoma
Procedure: Liver biopsy
Procedure: HVPG measurement

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2018 Years

Resource links provided by NLM:


Further study details as provided by Seoul National University Boramae Hospital:

Primary Outcome Measures:
  • Liver-related outcome: Decompensated liver cirrhosis, occurance of hepatocellular carcinoma [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Cumulative incidence within 5 years Laboratory Tests: Albumin, Total bilirubin, PT, Platelet Hepatic venous pressure gradient measurement Imaging study like Liver CT or Liver ultrasonography Endoscopy for varix evaluation


Secondary Outcome Measures:
  • Mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    overall mortality - whatever the cause of death

  • Liver-related mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    cumulative incidence of liver-related deaths


Biospecimen Retention:   Samples With DNA

At enrollement, 20 ml of blood will be collected for freezing and storage of serum and plasma, and constitution of a DNA library


Estimated Enrollment: 500
Study Start Date: January 2013
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Alcohol

Alcoholic Liver Cirrhosis

Participants will undergo liver biopsy.

Procedure: Liver biopsy Procedure: HVPG measurement
paired measurement
Hepatitis B virus
HBV Liver Cirrhosis
Procedure: Liver biopsy
Hepatitis C virus
HCV Liver Cirrhosis
Procedure: Liver biopsy
Autoimmune
Autoimmune Cirrhosis
Biliary
Primary or secondary biliary cirrhosis
Toxic
Medication related cirrhosis
Others
Other cirrhosis

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 HVPG 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, PBMC and DNA libraries; Data will be standardized and centralized in a single database.

And alcoholic LC patients will undergo liver biopsy for PCR, wetern blot, immunohistochemistry and RNA analysis.

After measurement of HVPG 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 HVPG 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 HVPG >=20% compared to baseline or to an absolute value <=12 mmHg. Compliance with therapy was monitored by monitoring of HR and blood pressure during clinical visits.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Seoul National University Boramae hospital

Criteria

Inclusion Criteria:

  • Age ≥19years old Proven cirrhosis
  • No previous HCC (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 HCC
  • patient under guardianship
  • pregnant women
  • inability to regular monitoring, for whatever reason
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01943318

Contacts
Contact: Hwi Young Kim, MD,PhD 821032411321 hykim@brmh.org

Locations
Korea, Republic of
SNU-SMG Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 156707
Contact: Hwi Young Kim, MD.PhD.    821032411321      
Sponsors and Collaborators
Seoul National University Boramae Hospital
  More Information

Publications:
Responsible Party: Hwi Young Kim, MD.PhD, MD, PhD, Seoul National University Boramae Hospital
ClinicalTrials.gov Identifier: NCT01943318     History of Changes
Other Study ID Numbers: BRM_LC_Cohort
Study First Received: August 22, 2013
Last Updated: February 9, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Boramae Hospital:
Liver Cirrhosis
Hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Cirrhosis
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 23, 2014