main objective: Investigate the prevalence of liver fibrosis according to TE values in children enrolled in a HPN-program. Secondary objectives: Investigate the correlation between TE values and ELF test score and APRI in children enrolled in a HPN-…
ID
Source
Brief title
Condition
- Other condition
- Gastrointestinal conditions NEC
- Hepatic and hepatobiliary disorders
Synonym
Health condition
Intestinaal Falen (verschillende onderliggende oorzaken mogelijk bijvoorbeeld: Short Bowel, Passagestoornissen, Microvili inclusieziekte)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Prevalence of fibrosis according to Transient Elastography (TE).
Secondary outcome
- Correlation between TE values and ELF test score and APRI.
- Correlation between TE values and standard laboratory liver parameters such
as AP, GGT, Bilirubin and transaminases.
- Correlation between TE values and known risk factors for the development of
IFALD.
Background summary
Intestinal failure-associated liver disease (IFALD) is the most prevalent
complication affecting children with intestinal failure receiving (long-term)
home parenteral nutrition (HPN). This heterogeneous disease can in it severest
form progress to end-stage liver failure requiring liver transplantation. A lot
of different definitions exist of this disease and up to now there is no
consensus on how it best be diagnosed. Since the presence and severity of IFALD
define treatment options (i.e. . type of lipid emulsion (LE) to infuse)
defining the presence and severity of IFALD is important. The current reference
standard for assessing the presence and severity of IFALD is liver biopsy, this
is a procedure with possible serious complications such as bleeding. New
diagnostic test to assess the severity of liver disease, Fibroscan*/Transient
Elastography(TE) and the Enhanced Liver Fibrosis (ELF) test score, could
provide a solution. Since these tests are non-invasive they could provide a
safe alternative. These tests have not been extensively tested in a cohort of
patients receiving long term parenteral nutrition. In this study we will
investigate our hypothesis that the Fibroscan*/TE can be used in children with
intestinal failure receiving long term parenteral nutrition to identify those
with IFALD and give a quantitative measure of the severity of fibrosis
present.
Study objective
main objective: Investigate the prevalence of liver fibrosis according to TE
values in children enrolled in a HPN-program. Secondary objectives: Investigate
the correlation between TE values and ELF test score and APRI in children
enrolled in a HPN-program; Investigate the correlation between TE values and
standard laboratory liver parameters in children enrolled in a HPN-program;
Investigate the correlation between TE values and known risk factors for the
development of IFALD in children enrolled in a HPN-program.
Study design
This cross-sectional study features one prospective cohort.
Study burden and risks
Participation entails that subjects do not need to visit the AMC an extra time.
Instead, the informed consent form is signed by parents and children *12 years
of age is signed directly after their outpatient clinic consult. After this the
measurements are performed (Fibroscan*/TE). As per usual after this the
subjects are referred to the outpatient laboratory of the AMC were blood will
be drawn. An extra vial of blood, containing 200µl (2,0ml) of serum will be
drawn where the ELF-test will be performed on. No extra venous puncture will be
performed for the sake of this study. Fibroscan*/TE measurement takes
approximately 5-10 minutes of time. There is some advantage for patients that
participate in this study. The data obtained from the FibroScan®/TE measurement
will give a better indication than traditional parameters on the presence of
liver fibrosis.The results of the Fibroscan*/TE and ELF-test measurement will
be extensively discussed by their consulting paediatrician. No incentive is
offered for participation in this study.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
* Written informed consent from parent(s)/caregiver(s) and if applicable subject (when *12 years of age)
* Must be enrolled in the HPN-programme of the ECH-AMC.
* Must receive HPN for at least 3 months continuously.
Exclusion criteria
* Age <3 months and *18 years
* Children with ascites present.
* Children who at the time of outpatient visit have been admitted up to two weeks prior of the outpatient visit due to an episode of septicaemia.
* Children who have not been fasting 3 hours before the measurement of liver stiffness.
* Children who are currently using known hepatotoxic medication other than the total parenteral nutrition formula that is prescribed by the HPN team.
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 | NL62525.018.17 |