Primary objective- To investigate whether the introduction of LiverMultiScan as a standardised diagnostic test for liver disease can match the diagnostic yield of existing biopsies.Secondary objective- To determine patient feedback from this…
ID
Source
Brief title
Condition
- Hepatic and hepatobiliary disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The liver iron, liver fat, cardiovascular function and the Liver Inflammation
Fibrosis scores (LIF) compared to biopsy results for iron, fat,
fibroinflammatory status and rejection
Secondary outcome
- Patient feedback from qualitative research
- Concordance between MR measurements of fibrosis/rejection and
elastography/blood tests
- Comparison of LIF with clinical diagnosis using blood tests and liver
histology
Background summary
Long-term survival after solid organ transplantation has increased during the
last decades due to improvements in surgical technique, peri-operative care,
and more efficient immunosuppression (IS). However, transplant recipients still
exhibit higher morbidity and mortality than the general population. One of the
main causes are co- morbidities negatively influenced by chronic IS drug usage.
It is, however, a very fine balance, as under-usage of IS can lead to
transplant rejection. Therefore, many paediatric and some adult liver
transplant recipients have regular liver biopsies as part of their serial
evaluation, so-called *routine liver biopsies*. Biopsy is performed if there is
suspected rejection, as no current non-invasive tests are both sensitive and
specific for rejection. However, liver biopsy carries a risk of complication (1
in 10,000), they are painful, sample only a tiny fraction of the liver and for
children there is a need to sedate. Therefore they are less than perfect for
serial evaluation.Identification of a reproducible and reliable non-invasive
assessment tool for the transplanted liver, such as multiparametric
quantitative MRI, would therefore substantially benefit the liver transplant
population.We would like to see if the implementation of LiverMultiScan to
monitor the transplant population and modify treatment can replace or equal the
yield of invasive liver biopsies in the post-transplant population.
Study objective
Primary objective
- To investigate whether the introduction of LiverMultiScan as a standardised
diagnostic test for liver disease can match the diagnostic yield of existing
biopsies.
Secondary objective
- To determine patient feedback from this population (transplant recipients) on
LiverMultiScan.
- To assess how multiparametric MRI correlates with other measures of fibrosis
and rejection (eg elastography, blood tests) in the evaluation of these
patients.
- To evaluate the utility of LMS in the diagnosis of de novo or recurrent liver
disease post-transplant
Study design
This will be a prospective, multi-centre, biomarker trial comparing the
accuracy of a new test (LiverMultiScan) against an existing test (Routine liver
biopsy) in the assessment of liver transplant recipients, designed in
accordance with the STARD criteria. Additional permission will be asked to
donate blood for the biobank for further research.
Study burden and risks
There are no anticipated risks associated with this study. The patients will
not recieve any direct benefit from participation. There is no gurantee or
promise that patients will recieve any benefits from this study.
Oxford Centre For Innovation, new Rd 1
Oxford OX1 1BY
GB
Oxford Centre For Innovation, new Rd 1
Oxford OX1 1BY
GB
Listed location countries
Age
Inclusion criteria
- Patient over 18 years old with a liver transplant.
- Patient due to undergo routine liver biopsy or biopsy for suspected pathology after liver transplantation
Exclusion criteria
- Any contraindication to magnetic resonance imaging (inc pregnancy, pacemaker, shrapnel injury, severe claustrophobia).
- Any contraindication to liver biopsy (coagulopathy, obstructed biliary tract with high risk bile leak, ascites etc)
- Patients who are unable to tolerate MRI without sedation or general anaesthetic
Design
Recruitment
metc-ldd@lumc.nl
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 | NL60644.058.17 |