To determine the clinical value of ultrasound, in addition to other non-invasive parameters of disease activity in children aged 3-18 with Crohn*s Disease.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Proportion of patients in whom POCUS led to a more severe classification of
disease activity than faecal calprotectin.
- Proportion of patients in whom POCUS would have altered choice for therapy
Secondary outcome
- Prognostic value of US for predicting a flare in the future
Background summary
Children with Crohn*s Disease need to be monitored closely in order to detect
and treat disease flare-ups in time. Pediatric gastroenterologists prefer to
use non-invasive tests, such as inflammatory markers in blood and faeces, as
much as possible, and to minimize the need for invasive procedures, such as
ileo-colonoscopies. However, these inflammatory markers are often inconclusive.
Using point-of-care ultrasound (POCUS) in addition to the currently used
non-invasive test in these children could improve clinical care.
Study objective
To determine the clinical value of ultrasound, in addition to other
non-invasive parameters of disease activity in children aged 3-18 with Crohn*s
Disease.
Study design
A single centre observational study. POCUS will be performed in all children
(aged 0-18) diagnosed with Crohn*s Disease, visiting the outpatient clinic, and
in whom inflammatory markers of disease activity will be determined for
standard care. POCUS results and inflammatory markers results will be
categorized in three categories: remission/ mild activity/ moderate-severe
activity. Impact of the POCUS on choosing treatment will be determined and
agreement between-, and additive value of POCUS and inflammatory markers
results will be assessed
Study burden and risks
Ultrasound is a safe, fast and non-invasive way of imaging, hence the extent of
the burden of participating is limited. The children will spend 30 minutes
longer in the outpatient department.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with Crohn's Disease
- Age 3-18 year
Exclusion criteria
- Proven gastro-enteritis
- Pregnant at time of examination
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 | NL72606.018.20 |