Chronic Liver DiseaseNCT01246388
Non-Invasive Evaluation of Fibrosis and Steatosis in Chronic Hepatopathy
An observational study of Chronic Liver Disease and Steatohepatitis, run by Tischendorf, Jens, M.D. at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate non-invasive parameters for staging and grading of chronic hepatopathy in comparison to liver biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease, Steatohepatitis, Fibrosis
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Dec 2014
- 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: 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
Who may be able to join
- Chronic hepatopathy and necessity of liver biopsy
Who cannot join
- metal implants preventing MRI
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine III, University Hospital Aachen (RWTH)
Aachen, 52074
About this study
Official title: Evaluation of Fibrosis and Steatosis in Patients With Chronic Hepatopathy: Non-invasive Imaging and Serum Markers vs. Liver Biopsy
The purpose of this study is to evaluate non-invasive parameters for staging and grading of chronic hepatopathy in comparison to liver biopsy.
Read the detailed description
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
- Chronic Liver Disease, Steatohepatitis, Fibrosis
- Keywords
- Fibrosis, Steatosis, Liver biopsy, Elastography, MRI
- Medical subject headings
- Fatty Liver, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Liver Disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Receiver operating characteristic analysis is performed (Area-under-the-ROC-curve) to evaluate non-invasive steatosis assessment (MR-spectroscopy, ultrasound)in comparison to the liver biopsy with SPSS-Software, p < 0,05 is regarded as statistically significant. The degree of steatosis in liver biopsies and ultrasound is assessed by a morphological semiquantitative approach: 0: none, 1: slight, 2: moderate and 3: severe.
Measured: singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2014
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tischendorf, Jens, M.D.
- Responsible party
- Sponsor
- Investigators
- Holger H Lutz, M.D., Principal investigator, Department of Medicine III, University Hospital RTWH University of Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246388
- Sponsor's protocol ID
- LU-TI-01
- Status last verified
- Mar 2012
- First submitted
- 31 Oct 2010
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19254351Bonekamp 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.
PubMed 19022517Faria 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.
PubMed 19959511
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fibrosis and Steatosis in Patients With Chronic Hepatopathy: Non-invasive Imaging and Serum Markers vs. Liver Biopsy
- ClinicalTrials.gov ID
- NCT01246388
- Acronym / sponsor ID
- LU-TI-01
- Conditions
- Chronic Liver Disease, Steatohepatitis, Fibrosis
- Keywords
- Fibrosis, Steatosis, Liver biopsy, Elastography, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tischendorf, Jens, M.D.
- Study start
- May 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 23 Nov 2010 (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 this study is to evaluate non-invasive parameters for staging and grading of chronic hepatopathy in comparison to liver biopsy.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Liver Disease | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Chronic hepatopathy and necessity of liver biopsy
Key exclusion criteria (1 listed)
- metal implants preventing MRI
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
Quality of staging fibrosis (METAVIR scoring system) with a combination of MRT and blood serum markers compared to liver biopsy (gold standard)
Time frame: singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy)
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).
1 secondary outcome
Quality of staging steatosis (four-graded scale, percentage) with a combination of MRT and blood serum markers compared to liver biopsy (gold standard)
Time frame: singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
- Background: PubMed 19254351Castera 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.
- Background: PubMed 19022517Bonekamp 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.
- Background: PubMed 19959511Faria 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.
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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.
Holger H Lutz, M.D. principal investigator
Department of Medicine III, University Hospital RTWH University of Aachen
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 Liver Disease and Steatohepatitis, run by Tischendorf, Jens, M.D. at 1 site in Germany.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Oct 2014. 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 Germany. 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?
Results are not available in the source record.
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.
What does the primary outcome measure?
Quality of staging fibrosis (METAVIR scoring system) with a combination of MRT and blood serum markers compared to liver biopsy (gold standard) (time frame: singular evaluation at the time of liver biopsy (completion of measurements within 2 days before or after liver biopsy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01246388, which also lists 3 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 21 Oct 2014.