Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466336
Status:
COMPLETED
Last Update Posted:
2008-03-06
First Post:
2007-04-25
Brief Title:
Prediction of Hepatic Fibrosis in Patients With Chronic Hepatitis C by Biochemical and Duplex Doppler Indices
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Prediction of Hepatic Fibrosis in Patients With Chronic Hepatitis C by Biochemical and Duplex Doppler Indices
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Chronic hepatitis C virus HCV infection is a global health problem affecting about 3 of the worlds 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 01-3 of significant morbidity and 002-024 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
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 01-3 of significant morbidity and 002-024 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None