Investigation of the prevalence of sinonasal disease on CT-sinus in children with Cystic Fibrosis at different ages. This study will focus especially on the onset of sinonasal pathology in Cystic Fibrosis in relation to the development of the…
ID
Source
Brief title
Condition
- Respiratory disorders congenital
- Bacterial infectious disorders
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Lund-Mackay scores on CT-sinus in children with CF.
Secondary outcome
Secondary study parameters will be the outcome of nasal cultures, symptoms of
sinonasal disease and anatomic variations in the sinonasal area.
Background summary
Sinonasal pathology in Cystic Fibrosis is very common. This genetic disease
predisposes a patient to the development of i.e. rhinosinusitis and/or nasal
polyps. Previous research in patients with CF showed a prevalence of 74-100% of
rhinosinusitis and 32-57% of nasal polyps. Moreover a very high prevalence of
anatomical abnormalities on computed tomography of the paranasal sinuses was
seen. Smaller paranasal sinuses, abnormal anatomy of the ostiomeatal complex
and bony changes of the sinus walls have been described. These findings
indicate a chronic course of sinonasal pathology. However, to date the onset
and the pathogenesis of this sinonasal pathology in Cystic Fibrosis is unclear.
More knowledge on the pathogenesis of sinonasal disease in CF is necessary to
develop an accurate treatment protocol for this pathology in CF. This research
also might result in early interventions on sinonasal pathology. Early
interventions may prevent a chronic course of sinonasal pathology and
eventually less complaints in adult life.
Study objective
Investigation of the prevalence of sinonasal disease on CT-sinus in children
with Cystic Fibrosis at different ages. This study will focus especially on the
onset of sinonasal pathology in Cystic Fibrosis in relation to the development
of the sinuses and bacterial infections.
Study design
Cross-sectional study.
Study burden and risks
In this study the patient will visit the hospital once. During this visit
computed tomography of the paranasal sinuses and a nasopharyngeal swab are
performed. In the Haga Teaching Hospital a dual source flash CT-scan will be
used to minimize the radiation dose. The estimated total dose of this CT-scan
is approximately 1 mSv. In the AMC a Philips Brilliance CT is used with an
estimated effective dose of 1 mSv. Since sinonasal disease in Cystic Fibrosis
is common, but the pathogenesis and the onset remain unclear, it is important
to study CT-sinuses in this particular group. This study can contribute to
development of an evidence based treatment and monitoring protocol for
sinonasal pathology in CF.
Leyweg 275
Den Haag 2545 CH
NL
Leyweg 275
Den Haag 2545 CH
NL
Listed location countries
Age
Inclusion criteria
* Confirmed diagnose of Cystic Fibrosis based on genotyping or a positive sweat test
* Age * 0 and <18 years
Exclusion criteria
* Gross immunodeficiency (congenital of acquired)
* Congenital mucociliary problems other than CF (e.g. Primairy ciliary dyskinesia)
* ASA syndrome (Samter*s triad; nasal polyps, asthma, and aspirin sensitivity)
* Intranasal neoplasia
* Systemic vasculitis and granulomatous diseases (e.g. M. Wegener, sarcoidosis, Churg-Strauss syndrome)
* Recently (within 1 month) CT-sinus performed
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL43794.098.13 |
| OMON | NL-OMON23697 |