Prediction of Hepatic Fibrosis in Patients With Chronic Hepatitis C by Biochemical and Duplex Doppler Indices
1 other identifier
observational
503
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2003
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 25, 2007
CompletedFirst Posted
Study publicly available on registry
April 27, 2007
CompletedMarch 6, 2008
March 1, 2008
3.9 years
April 25, 2007
March 5, 2008
Conditions
Keywords
Eligibility Criteria
Chronic hepatitis C patients with abnormal ALT levels (\> 2X ULN) with percutaneous liver biopsy
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
Related Publications (36)
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.
PMID: 9305656BACKGROUNDLauer 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.
PMID: 11439948BACKGROUNDYano 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.
PMID: 8675148BACKGROUNDde 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.
PMID: 1506645BACKGROUNDDaniele 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.
PMID: 15508073BACKGROUNDHeathcote 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.
PMID: 11106716BACKGROUNDPiccinino 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.
PMID: 3958472BACKGROUNDNord 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.
PMID: 6211383BACKGROUNDGarcia-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.
PMID: 8416312BACKGROUNDCadranel 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.
PMID: 10960438BACKGROUNDMcGill 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.
PMID: 2101588BACKGROUNDMaharaj 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.
PMID: 2869260BACKGROUNDBedossa 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.
PMID: 14647056BACKGROUNDColloredo 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.
PMID: 12873821BACKGROUNDFontana 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.
PMID: 12407577BACKGROUNDWilliams AL, Hoofnagle JH. Ratio of serum aspartate to alanine aminotransferase in chronic hepatitis. Relationship to cirrhosis. Gastroenterology. 1988 Sep;95(3):734-9. doi: 10.1016/s0016-5085(88)80022-2.
PMID: 3135226BACKGROUNDSheth SG, Flamm SL, Gordon FD, Chopra S. AST/ALT ratio predicts cirrhosis in patients with chronic hepatitis C virus infection. Am J Gastroenterol. 1998 Jan;93(1):44-8. doi: 10.1111/j.1572-0241.1998.044_c.x.
PMID: 9448172BACKGROUNDPark GJ, Lin BP, Ngu MC, Jones DB, Katelaris PH. Aspartate aminotransferase: alanine aminotransferase ratio in chronic hepatitis C infection: is it a useful predictor of cirrhosis? J Gastroenterol Hepatol. 2000 Apr;15(4):386-90. doi: 10.1046/j.1440-1746.2000.02172.x.
PMID: 10824882BACKGROUNDGiannini E, Risso D, Botta F, Chiarbonello B, Fasoli A, Malfatti F, Romagnoli P, Testa E, Ceppa P, Testa R. Validity and clinical utility of the aspartate aminotransferase-alanine aminotransferase ratio in assessing disease severity and prognosis in patients with hepatitis C virus-related chronic liver disease. Arch Intern Med. 2003 Jan 27;163(2):218-24. doi: 10.1001/archinte.163.2.218.
PMID: 12546613BACKGROUNDImbert-Bismut F, Ratziu V, Pieroni L, Charlotte F, Benhamou Y, Poynard T; MULTIVIRC Group. Biochemical markers of liver fibrosis in patients with hepatitis C virus infection: a prospective study. Lancet. 2001 Apr 7;357(9262):1069-75. doi: 10.1016/S0140-6736(00)04258-6.
PMID: 11297957BACKGROUNDMyers RP, Ratziu V, Imbert-Bismut F, Charlotte F, Poynard T; MULTIVIRC Group. Groupe d'Etude Multidisciplinaire sur les Pathologies Liees au Virus C. Biochemical markers of liver fibrosis: a comparison with historical features in patients with chronic hepatitis C. Am J Gastroenterol. 2002 Sep;97(9):2419-25. doi: 10.1111/j.1572-0241.2002.05997.x.
PMID: 12358267BACKGROUNDPoynard T, Bedossa P. Age and platelet count: a simple index for predicting the presence of histological lesions in patients with antibodies to hepatitis C virus. METAVIR and CLINIVIR Cooperative Study Groups. J Viral Hepat. 1997 May;4(3):199-208. doi: 10.1046/j.1365-2893.1997.00141.x.
PMID: 9181529BACKGROUNDWai CT, Greenson JK, Fontana RJ, Kalbfleisch JD, Marrero JA, Conjeevaram HS, Lok AS. A simple noninvasive index can predict both significant fibrosis and cirrhosis in patients with chronic hepatitis C. Hepatology. 2003 Aug;38(2):518-26. doi: 10.1053/jhep.2003.50346.
PMID: 12883497BACKGROUNDForns X, Ampurdanes S, Llovet JM, Aponte J, Quinto L, Martinez-Bauer E, Bruguera M, Sanchez-Tapias JM, Rodes J. Identification of chronic hepatitis C patients without hepatic fibrosis by a simple predictive model. Hepatology. 2002 Oct;36(4 Pt 1):986-92. doi: 10.1053/jhep.2002.36128.
PMID: 12297848BACKGROUNDCastera L, Vergniol J, Foucher J, Le Bail B, Chanteloup E, Haaser M, Darriet M, Couzigou P, De Ledinghen V. Prospective comparison of transient elastography, Fibrotest, APRI, and liver biopsy for the assessment of fibrosis in chronic hepatitis C. Gastroenterology. 2005 Feb;128(2):343-50. doi: 10.1053/j.gastro.2004.11.018.
PMID: 15685546BACKGROUNDLackner C, Struber G, Liegl B, Leibl S, Ofner P, Bankuti C, Bauer B, Stauber RE. Comparison and validation of simple noninvasive tests for prediction of fibrosis in chronic hepatitis C. Hepatology. 2005 Jun;41(6):1376-82. doi: 10.1002/hep.20717.
PMID: 15915455BACKGROUNDRosenberg WM, Voelker M, Thiel R, Becka M, Burt A, Schuppan D, Hubscher S, Roskams T, Pinzani M, Arthur MJ; European Liver Fibrosis Group. Serum markers detect the presence of liver fibrosis: a cohort study. Gastroenterology. 2004 Dec;127(6):1704-13. doi: 10.1053/j.gastro.2004.08.052.
PMID: 15578508BACKGROUNDGaiani S, Gramantieri L, Venturoli N, Piscaglia F, Siringo S, D'Errico A, Zironi G, Grigioni W, Bolondi L. What is the criterion for differentiating chronic hepatitis from compensated cirrhosis? A prospective study comparing ultrasonography and percutaneous liver biopsy. J Hepatol. 1997 Dec;27(6):979-85. doi: 10.1016/s0168-8278(97)80140-7.
PMID: 9453422BACKGROUNDKoda M, Murawaki Y, Kawasaki H, Ikawa S. Portal blood velocity and portal blood flow in patients with chronic viral hepatitis: relation to histological liver fibrosis. Hepatogastroenterology. 1996 Jan-Feb;43(7):199-202.
PMID: 8682462BACKGROUNDSacerdoti D, Merkel C, Bolognesi M, Amodio P, Angeli P, Gatta A. Hepatic arterial resistance in cirrhosis with and without portal vein thrombosis: relationships with portal hemodynamics. Gastroenterology. 1995 Apr;108(4):1152-8. doi: 10.1016/0016-5085(95)90214-7.
PMID: 7698583BACKGROUNDSchneider AW, Kalk JF, Klein CP. Hepatic arterial pulsatility index in cirrhosis: correlation with portal pressure. J Hepatol. 1999 May;30(5):876-81. doi: 10.1016/s0168-8278(99)80142-1.
PMID: 10365815BACKGROUNDBolognesi M, Sacerdoti D, Merkel C, Gerunda G, Maffei-Faccioli A, Angeli P, Jemmolo RM, Bombonato G, Gatta A. Splenic Doppler impedance indices: influence of different portal hemodynamic conditions. Hepatology. 1996 May;23(5):1035-40. doi: 10.1002/hep.510230515.
PMID: 8621130BACKGROUNDBolognesi M, Sacerdoti D, Merkel C, Bombonato G, Gatta A. Noninvasive grading of the severity of portal hypertension in cirrhotic patients by echo-color-Doppler. Ultrasound Med Biol. 2001 Jul;27(7):901-7. doi: 10.1016/s0301-5629(01)00370-2.
PMID: 11476922BACKGROUNDPiscaglia F, Gaiani S, Calderoni D, Donati G, Celli N, Gramantieri L, Crespi C, Bolondi L. Influence of liver fibrosis on hepatic artery Doppler resistance index in chronic hepatitis of viral origin. Scand J Gastroenterol. 2001 Jun;36(6):647-52. doi: 10.1080/003655201750163178.
PMID: 11424325BACKGROUNDLim AK, Patel N, Eckersley RJ, Kuo YT, Goldin RD, Thomas HC, Cosgrove DO, Taylor-Robinson SD, Blomley MJ. Can Doppler sonography grade the severity of hepatitis C-related liver disease? AJR Am J Roentgenol. 2005 Jun;184(6):1848-53. doi: 10.2214/ajr.184.6.01841848.
PMID: 15908541BACKGROUNDAube C, Winkfield B, Oberti F, Vuillemin E, Rousselet MC, Caron C, Cales P. New Doppler ultrasound signs improve the non-invasive diagnosis of cirrhosis or severe liver fibrosis. Eur J Gastroenterol Hepatol. 2004 Aug;16(8):743-51. doi: 10.1097/01.meg.0000108357.41221.e5.
PMID: 15256975BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chen-Hua Liu, MD
Department of Internal Medicine, National Taiwan Universitys Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 25, 2007
First Posted
April 27, 2007
Study Start
January 1, 2003
Primary Completion
December 1, 2006
Study Completion
January 1, 2007
Last Updated
March 6, 2008
Record last verified: 2008-03