Liver CirrhosisNCT01943318
Boramae Hospital Liver Cirrhosis Patient Cohort Study
An observational study of Liver Cirrhosis and Hepatocellular Carcinoma, run by Seoul National University Boramae Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Liver Cirrhosis, Hepatocellular Carcinoma
- What is being tested?
- Liver biopsy and Hepatic venous pressure gradient (HVPG) measurement
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to May 2022
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Seoul National University Boramae hospital
Who may be able to join
- Age ≥19years old Proven cirrhosis
- No previous hepatocellular carcinoma (treated or not)
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Cirrhosis, Hepatocellular Carcinoma
- Being tested
- Liver biopsy, Hepatic venous pressure gradient (HVPG) measurement
- Keywords
- Liver Cirrhosis, Hepatocellular carcinoma
- Medical subject headings
- Liver Cirrhosis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver biopsyProcedure or surgery
Histologic evaluation
Hepatic venous pressure gradient (HVPG) measurementDevice
Hepatic venous pressure gradient (HVPG) measurement
| Study group | Role | What they receive |
|---|---|---|
| Alcohol | Alcoholic Liver Cirrhosis
Participants will undergo liver biopsy. Participants will undergo hepatic venous pressure gradient measurement. Receives: Procedure: Liver biopsy; Device: Hepatic venous pressure gradient (HVPG) measurement | |
| Hepatitis B virus | Hepatitis B virus (HBV) Liver Cirrhosis Receives: Procedure: Liver biopsy; Device: Hepatic venous pressure gradient (HVPG) measurement | |
| Hepatitis C virus | Hepatitis C virus (HCV) Liver Cirrhosis Receives: Procedure: Liver biopsy; Device: Hepatic venous pressure gradient (HVPG) measurement | |
| Autoimmune | Autoimmune Cirrhosis Receives: Procedure: Liver biopsy; Device: Hepatic venous pressure gradient (HVPG) measurement | |
| Biliary | Primary or secondary biliary cirrhosis Receives: Procedure: Liver biopsy; Device: Hepatic venous pressure gradient (HVPG) measurement | |
| Toxic | Medication related cirrhosis Receives: Procedure: Liver biopsy; Device: Hepatic venous pressure gradient (HVPG) measurement | |
| Others | Hepatic venous pressure gradient (HVPG) measurement Receives: Procedure: Liver biopsy; Device: Hepatic venous pressure gradient (HVPG) measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (2)
Mortality
overall mortality - whatever the cause of death
Measured: 5 years
Liver-related mortality
cumulative incidence of liver-related deaths
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2022
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Boramae Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Kim, Seoul National University Boramae Hospital
- Investigators
- Won Kim, MD, Principal investigator, Boramae Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943318
- Sponsor's protocol ID
- BRM_LC_Cohort
- Status last verified
- Apr 2023
- First submitted
- 22 Aug 2013
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22428859Reiberger 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.
PubMed 22170417Cho 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.
PubMed 31858403Kim 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.
PubMed 30389550
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study to Evaluate Long-term Outcomes in Patients With Liver Cirrhosis of Boramae Hospital
- ClinicalTrials.gov ID
- NCT01943318
- Acronym / sponsor ID
- BRM_LC_Cohort
- Conditions
- Liver Cirrhosis, Hepatocellular Carcinoma
- Keywords
- Liver Cirrhosis, Hepatocellular carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Seoul National University Boramae HospitalUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- May 2022 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 16 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Alcohol | – | Procedure: Liver biopsy, Device: Hepatic venous pressure gradient (HVPG) measurementAlcoholic Liver Cirrhosis Participants will undergo liver biopsy. Participants will undergo hepatic venous pressure gradient measurement. |
| Hepatitis B virus | – | Procedure: Liver biopsy, Device: Hepatic venous pressure gradient (HVPG) measurementHepatitis B virus (HBV) Liver Cirrhosis |
| Hepatitis C virus | – | Procedure: Liver biopsy, Device: Hepatic venous pressure gradient (HVPG) measurementHepatitis C virus (HCV) Liver Cirrhosis |
| Autoimmune | – | Procedure: Liver biopsy, Device: Hepatic venous pressure gradient (HVPG) measurementAutoimmune Cirrhosis |
| Biliary | – | Procedure: Liver biopsy, Device: Hepatic venous pressure gradient (HVPG) measurementPrimary or secondary biliary cirrhosis |
| Toxic | – | Procedure: Liver biopsy, Device: Hepatic venous pressure gradient (HVPG) measurementMedication related cirrhosis |
| Others | – | Procedure: Liver biopsy, Device: Hepatic venous pressure gradient (HVPG) measurementHepatic venous pressure gradient (HVPG) measurement |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Seoul National University Boramae hospital
Key inclusion criteria (3 listed)
- Age ≥19years old Proven cirrhosis
- No previous hepatocellular carcinoma (treated or not)
- Signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver biopsyHistologic evaluation | Procedure or surgery | Alcohol, Autoimmune, Biliary, Hepatitis B virus, Hepatitis C virus, Others, Toxic |
| Hepatic venous pressure gradient (HVPG) measurementHepatic venous pressure gradient (HVPG) measurement | Device | Alcohol, Autoimmune, Biliary, Hepatitis B virus, Hepatitis C virus, Others, Toxic |
Primary outcome
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
2 secondary outcomes
Mortality
Time frame: 5 years
Liver-related mortality
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Background: PubMed 22428859Dam 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.
- Background: PubMed 22170417Reiberger 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.
- Derived from this study: PubMed 31858403Cho 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.
- Derived from this study: PubMed 30389550Kim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Won Kim, MD principal investigator
Boramae Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Hepatocellular Carcinoma, run by Seoul National University Boramae Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver-related outcome: Decompensated liver cirrhosis (ascites, variceal bleeding, hepatic encepahlopathy), occurence of hepatocellular carcinoma (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01943318, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.