Non-Invasive Evaluation of Fibrosis and Steatosis in Chronic Hepatopathy

NCT01246388 | Unknown

• 1 other identifier: LU-TI-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Liver Disease; Steatohepatitis; Fibrosis

Keywords

Fibrosis; Steatosis; Liver biopsy; Elastography; MRI

Outcome Measures

Primary Outcomes (1)

• Quality of staging fibrosis (METAVIR scoring system) with a combination of MRT and blood serum markers compared to liver biopsy (gold standard)

  Receiver operating characteristic analysis is performed (Area-under-the-ROC-curve) to evaluate non-invasive fibrosis assessment in comparison to the liver biopsy with SPSS-Software, p \< 0,05 is regarded as statistically significant. METAVIR is a 5-point scale used in staging fibrosis (0 = no fibrosis, 4 = high grade fibrosis, cirrhosis).

  singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy)

Secondary Outcomes (1)

• Quality of staging steatosis (four-graded scale, percentage) with a combination of MRT and blood serum markers compared to liver biopsy (gold standard)

  singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy)

Study Arms (1)

Chronic Liver Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

in- and outclinic patients of the RTWH University Hospital (Department of Medicine III) with chronic hepatopathy and the necessity of undergoing liver biopsy for diagnostic work up

You may qualify if:

• Chronic hepatopathy and necessity of liver biopsy

You may not qualify if:

• metal implants preventing MRI

Sponsors & Collaborators

• Tischendorf, Jens, M.D.: lead

Study Sites (1)

Department of Medicine III, University Hospital Aachen (RWTH)

Aachen, 52074, Germany

Location

Related Publications (3)

• 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.

  PMID: 19254351 BACKGROUND

• 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.

  PMID: 19022517 BACKGROUND

• 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.

  PMID: 19959511 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Serum

MeSH Terms

Conditions

Fatty Liver; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Holger H Lutz, M.D.

  Department of Medicine III, University Hospital RTWH University of Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2010
• First Posted: November 23, 2010
• Study Start: May 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 21, 2014

Record last verified: 2012-03

Locations

DE (1)