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Prediction of Hepatic Fibrosis in Patients With Chronic Hepatitis C by Biochemical and Duplex Doppler Indices

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00466336
Collaborator
(none)
503
Enrollment
1
Location
48
Duration (Months)
10.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of our prospective study was to evaluate the value of Doppler parameters and compare the diagnostic accuracy of Doppler parameters with various biochemical indices in predicting significant hepatic fibrosis (≥ F2) and cirrhosis (F4) in chronic hepatitis C (CHC) patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Chronic hepatitis C virus (HCV) infection is a global health problem, affecting about 3% of the world's population. Compared to patients with mild hepatic fibrosis, those with significant fibrosis are at risk of developing cirrhosis over a 10- to 20-year period. This fact suggests the need of early antiviral therapy in chronic hepatitis C (CHC) patients to prevent the development of cirrhosis and associated complications. For patients having cirrhosis, surveillance endoscopy and ultrasound for gastroesophageal varices and hepatocellular carcinoma are needed to minimize morbidity and mortality ). Furthermore, reduced treatment response and tolerability to antiviral therapy may be encountered in cirrhotic patients. An accurate assessment of hepatic fibrosis stage is therefore important for both diagnostic and therapeutic purposes.

    Liver biopsy has been recognized as the gold standard for assessing the grade of necroinflammation and stage of fibrosis. However, it is costly, and harbors risk of complications, including 20% of patient discomfort, 0.1-3% of significant morbidity, and 0.02-0.24% of mortality. In addition, sampling error due to the non-uniform distribution of the parenchymal damage, as well as intra- and inter-observer variability is often encountered. A noninvasive tool to evaluate liver disease activity or fibrosis stage would be helpful, particularly in monitoring CHC patients over time.

    Noninvasive methods to evaluate the hepatic histology in HCV-infected patients include symptoms and signs, routine laboratory tests, serum markers of fibrosis and inflammation, quantitative tests of liver function, and radiological imaging. Previous studies have assessed the usefulness of noninvasive tests in predicting hepatic fibrosis. However, none of them showed satisfactory results, either due to lack of accuracy, accessibility, reproducibility or being expensive.

    Duplex Doppler ultrasonography (DDU), which is readily available and non-invasive, has been used for the assessment of splanchnic vascular hemodynamics in patients with chronic liver disease. Portal vein velocity (PVV) has been shown to be correlated with significant fibrosis or cirrhosis. Hepatic artery resistive index (HARI) and pulsatility index (HAPI) are associated with portal vein resistance and hepatic vein-portal vein pressure gradient (HPVG). Splenic artery resistive index (SARI) and pulsatility index (SAPI) are associated with portal vein resistance, cirrhosis and grade of esophageal varices (EV). Previous studies to evaluate the value of DDU in predicting liver histology are controversial, probably due to small patient number, diverse grading of liver histology, and large missing data.

    Thus, the purpose of our prospective study was to evaluate the value of Doppler parameters and compare the diagnostic accuracy of Doppler parameters with various biochemical indices in predicting significant hepatic fibrosis (≥ F2) and cirrhosis (F4) in chronic hepatitis C (CHC) patients.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    503 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Prediction of Hepatic Fibrosis in Patients With Chronic Hepatitis C by Biochemical and Duplex Doppler Indices
    Study Start Date :
    Jan 1, 2003
    Actual Primary Completion Date :
    Dec 1, 2006
    Actual Study Completion Date :
    Jan 1, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Age older than 18 years

      • Positive anti-HCV and HCV RNA for more than 6 months

      • Alanine aminotransferase level more than twice the upper limit of normal (ULN)

      Exclusion Criteria:

      • HBV and HCV co-infection

      • HIV and HCV co-infection

      • Heavy alcohol use (> 50 gram/day)

      • Autoimmune liver diseases

      • Metabolic liver diseases

      • Presence of hepatocellular carcinoma

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 National Taiwan University Hospital Taipei Taiwan 100

      Sponsors and Collaborators

      • National Taiwan University Hospital

      Investigators

      • Study Director: Chen-Hua Liu, MD, Department of Internal Medicine, National Taiwan Universitys Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00466336
      Other Study ID Numbers:
      • 200612012R
      First Posted:
      Apr 27, 2007
      Last Update Posted:
      Mar 6, 2008
      Last Verified:
      Mar 1, 2008
      Keywords provided by , ,
      Chronic hepatitis C
      Non-invasive diagnosis
      Duplex Doppler ultrasonography
      Biochemical indices
      Hepatic fibrosis
      Cirrhosis
      Additional relevant MeSH terms:
      Hepatitis A
      Hepatitis C
      Hepatitis C, Chronic
      Hepatitis
      Hepatitis, Chronic
      Liver Cirrhosis
      Fibrosis

      Study Results

      No Results Posted as of Mar 6, 2008