To assess the diagnostic accuracy of MR Elastography in detecting and monitoring different degrees of liver fibrosis compared to FibroScan and histopathology in patients with suspected chronic viral liver disease and non-alcoholic fatty liver…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessment of the diagnostic accuracy of MR Elastography in diagnosing liver
fibrosis compared with FibroScan and histopathology in patients suspected of
chronic viral liver disease and non-alcoholic fatty liver disease.
Secondary outcome
*The feasibility of combining MR Elastography and proton MR Spectroscopy in
non-alcoholic fatty liver disease to distinguish between simple steatosis and
NASH.
*The evaluation of antiviral treatment response with combined MR Elastography
and MR Spectroscopy versus FibroScan in patients with chronic viral liver
disease.
*The influence of increased hepatic fat content and inflammatory activity on
viscoelasticity measurements.
*The burden of liver biopsy, MR Elastography and FibroScan.
Background summary
The prognosis of patients with chronic liver disease depends to a high degree
on the presence and degree of liver fibrosis. In this respect determination of
different degrees of liver fibrosis is crucial for the management of chronic
liver disease. Liver biopsy is the current gold standard for diagnosing chronic
liver disease. However, liver biopsy is accompanied by the risk of
complications, patient discomfort and poor reproducibility due to sampling
errors. Transient Elastography (FibroScan) is now used as a non-invasive
alternative to detect liver fibrosis by measuring liver stiffness. This
ultrasound technique can differentiate between severe liver fibrosis and no
fibrosis, but is not sensitive enough to measure lower degrees of liver
fibrosis. Furthermore, increased hepatic fat content and inflammatory activity
has a possible confounding effect on the fibrosis measurement. Magnetic
Resonance Elastography (MRE) has been introduced as a new and accurate
non-invasive method to determine liver fibrosis. MRE provides reproducible
viscoelastic information of the whole liver, and is not prone to sampling
errors. However, the findings of MRE have been studied in a wide spectrum of
chronic liver diseases. At this moment it is not clear whether these findings
can be applied unconditionally to specific patient groups such as chronic viral
liver disease (Hepatitis B, C) or chronic non-viral liver disease
(non-alcoholic fatty liver disease, NAFLD). Using MRE in specific patient
groups could provide an accurate and non-invasive tool for diagnosing different
stages of liver fibrosis and to monitor treatment response. Moreover, combining
MRE with Proton Magnetic Resonance Spectroscopy (1H-MRS) in NAFLD patients
could offer a non-invasive way to discriminate between simple steatosis and the
more serious condition of non-alcoholic steatohepatitis (NASH), the latter of
which is prone to the development of hepatic fibrosis and cirrhosis.
Study objective
To assess the diagnostic accuracy of MR Elastography in detecting and
monitoring different degrees of liver fibrosis compared to FibroScan and
histopathology in patients with suspected chronic viral liver disease and
non-alcoholic fatty liver disease.
Study design
In this single centre, non-randomized prospective study all consecutive,
consenting adult patients with suspected chronic viral liver disease and
non-alcoholic fatty liver disease from our Gastroenterology department with an
indication for liver biopsy will be included.
Study burden and risks
MR Elastography and proton MR Spectroscopy (1H-MRS) will be combined in one MRI
session of approximately 60 minutes. Both MRE and 1H-MRS are non-invasive,
non-ionizing examinations, during which the patient will have to lie still on
his back in a MRI scanner. No contrast medium will be administered. All
participating patients will be asked permission to be contacted again for a
follow-up MRE/1H-MRS scan. Only consenting patients with proven viral hepatitis
will be included in this follow-up subgroup. This means that participating in
the study will require either one or two extra visits to the hospital,
depending on the patients* individual diagnosis.
Participating in this study has no direct advantage for the patient, except
extra insight in their disease. Patients are not delayed in treatment for their
disease. There will be little extra physical and psychological discomfort
associated with participation.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients over 18 years of age;
Patients suspected of chronic viral or chronic non-alcoholic liver disease with an indication for liver biopsy (ASAT elevated >60 mmol/l (n<=40 mmol/l));
Written informed consent
Exclusion criteria
Patients under 18 years of age;
Alcohol consumption of >3 units/day for males and >2 units/day for females;
Patients who are pregnant;
Patients who are claustrophobic (MRI scanner);
Patients who have magnetic or radiofrequency sensitive implants (MRI scanner);
Patients with extreme obesity (MRI scanner)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL27571.018.09 |