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Boramae Hospital Liver Cirrhosis Patient Cohort Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Seoul National University Boramae Hospital
Sponsor:
Information provided by (Responsible Party):
Won Kim, Seoul National University Boramae Hospital
ClinicalTrials.gov Identifier:
NCT01943318
First received: August 22, 2013
Last updated: May 4, 2016
Last verified: April 2016
  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
Device: Hepatic venous pressure gradient (HVPG) measurement

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: Prospective Cohort Study to Evaluate Long-term Outcomes in Patients With Liver Cirrhosis of Boramae Hospital

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, occurence of hepatocellular carcinoma [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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


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 Study Completion Date: March 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 measurement (Internal jugular venous catheter)
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 measurement (Internal jugular venous catheter)
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 measurement (Internal jugular venous catheter)
Autoimmune
Autoimmune Cirrhosis
Procedure: Liver biopsy
Histologic evaluation
Device: Hepatic venous pressure gradient (HVPG) measurement
hepatic venous pressure gradient measurement (Internal jugular venous catheter)
Biliary
Primary or secondary biliary cirrhosis
Procedure: Liver biopsy
Histologic evaluation
Device: Hepatic venous pressure gradient (HVPG) measurement
hepatic venous pressure gradient measurement (Internal jugular venous catheter)
Toxic
Medication related cirrhosis
Procedure: Liver biopsy
Histologic evaluation
Device: Hepatic venous pressure gradient (HVPG) measurement
hepatic venous pressure gradient measurement (Internal jugular venous catheter)
Others
Other cirrhosis
Procedure: Liver biopsy
Histologic evaluation
Device: Hepatic venous pressure gradient (HVPG) measurement
hepatic venous pressure gradient measurement (Internal jugular venous catheter)

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.

  Eligibility

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
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 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
  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: Sae Kyung Joo, MD 821089619285 joo.sammy@gmail.com

Locations
Korea, Republic of
SNU-SMG Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 156707
Contact: Sae Kyung Joo, MD.    821089619285    joo.sammy@gmail.com   
Sponsors and Collaborators
Seoul National University Boramae Hospital
Investigators
Principal Investigator: Won Kim, MD Boramae Hospital
  More Information

Publications:
Responsible Party: Won Kim, 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: May 4, 2016
Health Authority: Korea: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

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

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

ClinicalTrials.gov processed this record on September 27, 2016