Chronic Hepatitis CNCT00466336
Prediction of Hepatic Fibrosis in Patients With Chronic Hepatitis C by Biochemical and Duplex Doppler Indices
An observational study of Chronic Hepatitis C and Hepatic Fibrosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C, Hepatic Fibrosis, Cirrhosis
- How many people
- 503 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2003to Jan 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic hepatitis C patients with abnormal ALT levels (> 2X ULN) with percutaneous liver biopsy
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Hepatitis C, Hepatic Fibrosis, Cirrhosis
- Keywords
- Chronic hepatitis C, Non-invasive diagnosis, Duplex Doppler ultrasonography, Biochemical indices, Hepatic fibrosis, Cirrhosis
- Medical subject headings
- Hepatitis C, Chronic, Liver Cirrhosis, Fibrosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startJan 2003
- Primary completionDec 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chen-Hua Liu, MD, Study director, Department of Internal Medicine, National Taiwan Universitys Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466336
- Sponsor's protocol ID
- 200612012R
- Status last verified
- Mar 2008
- First submitted
- 25 Apr 2007
- Last updated
- 6 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
National Institutes of Health Consensus Development Conference Panel statement: management of hepatitis C. Hepatology. 1997 Sep;26(3 Suppl 1):2S-10S. doi: 10.1002/hep.510260701.
PubMed 9305656Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. doi: 10.1056/NEJM200107053450107. No abstract available.
PubMed 11439948Yano M, Kumada H, Kage M, Ikeda K, Shimamatsu K, Inoue O, Hashimoto E, Lefkowitch JH, Ludwig J, Okuda K. The long-term pathological evolution of chronic hepatitis C. Hepatology. 1996 Jun;23(6):1334-40. doi: 10.1002/hep.510230607.
PubMed 8675148de Franchis R, Pascal JP, Ancona E, Burroughs AK, Henderson M, Fleig W, Groszmann R, Bosch J, Sauerbruch T, Soederlund C, et al. Definitions, methodology and therapeutic strategies in portal hypertension. A Consensus Development Workshop, Baveno, Lake Maggiore, Italy, April 5 and 6, 1990. J Hepatol. 1992 May;15(1-2):256-61. doi: 10.1016/0168-8278(92)90044-p. No abstract available.
PubMed 1506645Daniele B, Bencivenga A, Megna AS, Tinessa V. Alpha-fetoprotein and ultrasonography screening for hepatocellular carcinoma. Gastroenterology. 2004 Nov;127(5 Suppl 1):S108-12. doi: 10.1053/j.gastro.2004.09.023.
PubMed 15508073Heathcote EJ, Shiffman ML, Cooksley WG, Dusheiko GM, Lee SS, Balart L, Reindollar R, Reddy RK, Wright TL, Lin A, Hoffman J, De Pamphilis J. Peginterferon alfa-2a in patients with chronic hepatitis C and cirrhosis. N Engl J Med. 2000 Dec 7;343(23):1673-80. doi: 10.1056/NEJM200012073432302.
PubMed 11106716Piccinino F, Sagnelli E, Pasquale G, Giusti G. Complications following percutaneous liver biopsy. A multicentre retrospective study on 68,276 biopsies. J Hepatol. 1986;2(2):165-73. doi: 10.1016/s0168-8278(86)80075-7.
PubMed 3958472Nord HJ. Biopsy diagnosis of cirrhosis: blind percutaneous versus guided direct vision techniques--a review. Gastrointest Endosc. 1982 May;28(2):102-4. doi: 10.1016/s0016-5107(82)73015-9. No abstract available.
PubMed 6211383Garcia-Tsao G, Boyer JL. Outpatient liver biopsy: how safe is it? Ann Intern Med. 1993 Jan 15;118(2):150-3. doi: 10.7326/0003-4819-118-2-199301150-00013. No abstract available.
PubMed 8416312Cadranel JF, Rufat P, Degos F. Practices of liver biopsy in France: results of a prospective nationwide survey. For the Group of Epidemiology of the French Association for the Study of the Liver (AFEF). Hepatology. 2000 Sep;32(3):477-81. doi: 10.1053/jhep.2000.16602.
PubMed 10960438McGill DB, Rakela J, Zinsmeister AR, Ott BJ. A 21-year experience with major hemorrhage after percutaneous liver biopsy. Gastroenterology. 1990 Nov;99(5):1396-400. doi: 10.1016/0016-5085(90)91167-5.
PubMed 2101588Maharaj B, Maharaj RJ, Leary WP, Cooppan RM, Naran AD, Pirie D, Pudifin DJ. Sampling variability and its influence on the diagnostic yield of percutaneous needle biopsy of the liver. Lancet. 1986 Mar 8;1(8480):523-5. doi: 10.1016/s0140-6736(86)90883-4.
PubMed 2869260Bedossa P, Dargere D, Paradis V. Sampling variability of liver fibrosis in chronic hepatitis C. Hepatology. 2003 Dec;38(6):1449-57. doi: 10.1016/j.hep.2003.09.022.
PubMed 14647056Colloredo G, Guido M, Sonzogni A, Leandro G. Impact of liver biopsy size on histological evaluation of chronic viral hepatitis: the smaller the sample, the milder the disease. J Hepatol. 2003 Aug;39(2):239-44. doi: 10.1016/s0168-8278(03)00191-0.
PubMed 12873821Fontana RJ, Lok AS. Noninvasive monitoring of patients with chronic hepatitis C. Hepatology. 2002 Nov;36(5 Suppl 1):S57-64. doi: 10.1053/jhep.2002.36800.
PubMed 12407577
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Hepatic Fibrosis in Patients With Chronic Hepatitis C by Biochemical and Duplex Doppler Indices
- ClinicalTrials.gov ID
- NCT00466336
- Acronym / sponsor ID
- 200612012R
- Conditions
- Chronic Hepatitis C, Hepatic Fibrosis, Cirrhosis
- Keywords
- Chronic hepatitis C, Non-invasive diagnosis, Duplex Doppler ultrasonography, Biochemical indices, Hepatic fibrosis, Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 27 Apr 2007 (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.
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 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic hepatitis C patients with abnormal ALT levels (> 2X ULN) with percutaneous liver biopsy
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- HBV and HCV co-infection
- HIV and HCV co-infection
- Heavy alcohol use (> 50 gram/day)
- Autoimmune liver diseases
- Metabolic liver diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 6 Mar 2008.
- Background: PubMed 9305656National Institutes of Health Consensus Development Conference Panel statement: management of hepatitis C. Hepatology. 1997 Sep;26(3 Suppl 1):2S-10S. doi: 10.1002/hep.510260701.
- Background: PubMed 11439948Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001 Jul 5;345(1):41-52. doi: 10.1056/NEJM200107053450107. No abstract available.
- Background: PubMed 8675148Yano M, Kumada H, Kage M, Ikeda K, Shimamatsu K, Inoue O, Hashimoto E, Lefkowitch JH, Ludwig J, Okuda K. The long-term pathological evolution of chronic hepatitis C. Hepatology. 1996 Jun;23(6):1334-40. doi: 10.1002/hep.510230607.
- Background: PubMed 1506645de Franchis R, Pascal JP, Ancona E, Burroughs AK, Henderson M, Fleig W, Groszmann R, Bosch J, Sauerbruch T, Soederlund C, et al. Definitions, methodology and therapeutic strategies in portal hypertension. A Consensus Development Workshop, Baveno, Lake Maggiore, Italy, April 5 and 6, 1990. J Hepatol. 1992 May;15(1-2):256-61. doi: 10.1016/0168-8278(92)90044-p. No abstract available.
- Background: PubMed 15508073Daniele B, Bencivenga A, Megna AS, Tinessa V. Alpha-fetoprotein and ultrasonography screening for hepatocellular carcinoma. Gastroenterology. 2004 Nov;127(5 Suppl 1):S108-12. doi: 10.1053/j.gastro.2004.09.023.
- Background: PubMed 11106716Heathcote EJ, Shiffman ML, Cooksley WG, Dusheiko GM, Lee SS, Balart L, Reindollar R, Reddy RK, Wright TL, Lin A, Hoffman J, De Pamphilis J. Peginterferon alfa-2a in patients with chronic hepatitis C and cirrhosis. N Engl J Med. 2000 Dec 7;343(23):1673-80. doi: 10.1056/NEJM200012073432302.
- Background: PubMed 3958472Piccinino F, Sagnelli E, Pasquale G, Giusti G. Complications following percutaneous liver biopsy. A multicentre retrospective study on 68,276 biopsies. J Hepatol. 1986;2(2):165-73. doi: 10.1016/s0168-8278(86)80075-7.
- Background: PubMed 6211383Nord HJ. Biopsy diagnosis of cirrhosis: blind percutaneous versus guided direct vision techniques--a review. Gastrointest Endosc. 1982 May;28(2):102-4. doi: 10.1016/s0016-5107(82)73015-9. No abstract available.
- Background: PubMed 8416312Garcia-Tsao G, Boyer JL. Outpatient liver biopsy: how safe is it? Ann Intern Med. 1993 Jan 15;118(2):150-3. doi: 10.7326/0003-4819-118-2-199301150-00013. No abstract available.
- Background: PubMed 10960438Cadranel JF, Rufat P, Degos F. Practices of liver biopsy in France: results of a prospective nationwide survey. For the Group of Epidemiology of the French Association for the Study of the Liver (AFEF). Hepatology. 2000 Sep;32(3):477-81. doi: 10.1053/jhep.2000.16602.
- Background: PubMed 2101588McGill DB, Rakela J, Zinsmeister AR, Ott BJ. A 21-year experience with major hemorrhage after percutaneous liver biopsy. Gastroenterology. 1990 Nov;99(5):1396-400. doi: 10.1016/0016-5085(90)91167-5.
- Background: PubMed 2869260Maharaj B, Maharaj RJ, Leary WP, Cooppan RM, Naran AD, Pirie D, Pudifin DJ. Sampling variability and its influence on the diagnostic yield of percutaneous needle biopsy of the liver. Lancet. 1986 Mar 8;1(8480):523-5. doi: 10.1016/s0140-6736(86)90883-4.
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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.
Chen-Hua Liu, MD study director
Department of Internal Medicine, National Taiwan Universitys 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 Chronic Hepatitis C and Hepatic Fibrosis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 6 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 6 Mar 2008. 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 Taiwan. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00466336, which also lists 36 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 6 Mar 2008.