NCT00466336

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
503

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
Last Updated

March 6, 2008

Status Verified

March 1, 2008

Enrollment Period

3.9 years

First QC Date

April 25, 2007

Last Update Submit

March 5, 2008

Conditions

Keywords

Chronic hepatitis CNon-invasive diagnosisDuplex Doppler ultrasonographyBiochemical indicesHepatic fibrosisCirrhosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Related Publications (36)

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    PMID: 9305656BACKGROUND
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    PMID: 3958472BACKGROUND
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    PMID: 6211383BACKGROUND
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    PMID: 8416312BACKGROUND
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    PMID: 10960438BACKGROUND
  • McGill 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: 2101588BACKGROUND
  • Maharaj 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: 2869260BACKGROUND
  • Bedossa 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: 14647056BACKGROUND
  • Colloredo 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: 12873821BACKGROUND
  • Fontana 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: 12407577BACKGROUND
  • Williams 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: 3135226BACKGROUND
  • Sheth 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: 9448172BACKGROUND
  • Park 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: 10824882BACKGROUND
  • Giannini 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: 12546613BACKGROUND
  • Imbert-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: 11297957BACKGROUND
  • Myers 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: 12358267BACKGROUND
  • Poynard 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: 9181529BACKGROUND
  • Wai 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: 12883497BACKGROUND
  • Forns 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: 12297848BACKGROUND
  • Castera 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: 15685546BACKGROUND
  • Lackner 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: 15915455BACKGROUND
  • Rosenberg 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: 15578508BACKGROUND
  • Gaiani 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: 9453422BACKGROUND
  • Koda 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: 8682462BACKGROUND
  • Sacerdoti 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: 7698583BACKGROUND
  • Schneider 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: 10365815BACKGROUND
  • Bolognesi 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: 8621130BACKGROUND
  • Bolognesi 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: 11476922BACKGROUND
  • Piscaglia 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: 11424325BACKGROUND
  • Lim 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: 15908541BACKGROUND
  • Aube 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

Hepatitis C, ChronicLiver CirrhosisFibrosis

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chen-Hua Liu, MD

    Department of Internal Medicine, National Taiwan Universitys Hospital

    STUDY DIRECTOR

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

Locations