Non-Invasive Evaluation of Fibrosis and Steatosis in Chronic Hepatopathy

NCT ID: NCT01246388

Last Updated: 2014-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-12-31

Brief Summary

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The purpose of this study is to evaluate non-invasive parameters for staging and grading of chronic hepatopathy in comparison to liver biopsy.

Detailed Description

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For diagnosis, staging and grading of chronic liver disease, liver biopsy is the gold standard to date. Unfortunately, being an invasive diagnostic method, liver biopsy has a significant morbidity. Furthermore, due to the small sample size, sampling error (over- or underestimating severity of liver disease) is a serious problem in diagnostic of chronic liver disease.

The objective of this study is to evaluate non-invasive diagnostic methods (MRI, elastography, ultrasound and serum parameters) in comparison to the gold standard to establish criteria for diagnostic in liver disease and reduce the necessary amount of liver biopsies in the future and allow regular follow up.

Conditions

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Chronic Liver Disease Steatohepatitis Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic Liver Disease

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Chronic hepatopathy and necessity of liver biopsy

Exclusion Criteria

* metal implants preventing MRI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tischendorf, Jens, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Holger H Lutz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine III, University Hospital RTWH University of Aachen

Locations

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Department of Medicine III, University Hospital Aachen (RWTH)

Aachen, , Germany

Site Status

Countries

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Germany

References

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Castera L. Transient elastography and other noninvasive tests to assess hepatic fibrosis in patients with viral hepatitis. J Viral Hepat. 2009 May;16(5):300-14. doi: 10.1111/j.1365-2893.2009.01087.x. Epub 2009 Feb 25.

Reference Type BACKGROUND
PMID: 19254351 (View on PubMed)

Bonekamp S, Kamel I, Solga S, Clark J. Can imaging modalities diagnose and stage hepatic fibrosis and cirrhosis accurately? J Hepatol. 2009 Jan;50(1):17-35. doi: 10.1016/j.jhep.2008.10.016. Epub 2008 Nov 8.

Reference Type BACKGROUND
PMID: 19022517 (View on PubMed)

Faria SC, Ganesan K, Mwangi I, Shiehmorteza M, Viamonte B, Mazhar S, Peterson M, Kono Y, Santillan C, Casola G, Sirlin CB. MR imaging of liver fibrosis: current state of the art. Radiographics. 2009 Oct;29(6):1615-35. doi: 10.1148/rg.296095512.

Reference Type BACKGROUND
PMID: 19959511 (View on PubMed)

Other Identifiers

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LU-TI-01

Identifier Type: -

Identifier Source: org_study_id

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