to assess the diagnostic accuracy of CSI (at 5, 10 and 15 cm proximal to the upper border of the lower esophageal sphincter) for the presence of active disease and/or complete remission in pediatric EoE.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic test accuracy of CSI to assess *active disease* or *complete
remission* compared to reference standard (EGD with histology).
Secondary outcome
• To establish the change in CSI with changing inflammation
• To calculate inter- and intrarater variability of CSI
• To establish a cut-off value for (change in) CSI for the presence / absence
of EoE
• To perform a cross-validation
• To assess the patient burden of patients and parents of CSI and
esophagogastroduodenoscopy and compare them.
• Cost-effectiveness assessment
Background summary
Eosinophilic esophagitis (EoE) is a chronic inflammation of the esophagus that
is triggered by ingestion of food proteins. The current gold standard for the
diagnosis and follow-up of EoE is esophagogastroduodenoscopy (EGD) with at
least 6 biopsies. During follow up, symptoms are well known not to correlate
with histological disease severity and therefore, frequent EGD with biopsies
are needed for evaluation of treatment success and/or to tailor treatment.
EGD*s in children are not only invasive by nature, but are performed under
general anesthetics. A less invasive test for the diagnosis and follow-up of
EoE, especially in children, is thus desired.
Recently, ''contractile segment impedance' (CSI), an impedance-manometry
derived parameter, prooved to be a good marker for the activity of inflammation
in other inflammatory processes. Existing data suggests that CSI could be of
diagnostic value in EoE.
Study objective
to assess the diagnostic accuracy of CSI (at 5, 10 and 15 cm proximal to the
upper border of the lower esophageal sphincter) for the presence of active
disease and/or complete remission in pediatric EoE.
Study design
This is a multicenter cross-sectional study in pediatric patients who undergo a
routine EGD with biopsies for the diagnosis or follow-up of EoE. These children
will be offered an additional impedance-manometry, with calculation of CSI.
This will be compared to the clinical histology results.
Study burden and risks
Participants of this study will have all standard care visits and EGD*s for
EoE. Apart from standard care, they need to visit the hospital one additional
time for CSI assessment during HRIM. HRIM is a very safe procedure. The
catheter can give minor discomfort in the nose and pharynx. In rare cases a
minor mucosal bleeding of the nose, caused by the catheter, can occur which
never needs additional treatment. We have recently shown that this test is very
well tolerated in children.(13) Additionally, study participants need to fill
out three short questionnaires (less than 10 minutes in total)
Participants will experience no direct benefit from this study, as the clinical
decisions in this study will be based on the currently used diagnostics (EGD +
histology). However, if our hypothesis will be proven and CSI will become an
accepted less invasive test for EoE activity, participants may indirectly
benefit from their participation in the future.
The current therapeutic options consist of complex elimination diets,
corticosteroids and/or proton pump inhibitors (PPI), depending on the choice of
parents and children. Corticosteroids and PPIs have several side effects,
especially in children. Despite their known complications, many children and
their families choose for PPI or corticosteroid therapy, because the
elimination diet (favorable because long-term safety) requires more EGD*s to
identify the food protein(s) that triggers EoE. While adults undergo EGD with
only mild- or no sedation, children require general anesthesia. HRIM (with CSI
measurement) could potentially dramatically reduce the number of EGD*s needed
in children with EOE.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Children aged 12-20 years who will undergo an esophagogastroduodenoscopy for
the diagnosis or follow-up of EoE.
Exclusion criteria
Inability to speak/understand English (Australia) or Dutch (The Netherlands)
Design
Recruitment
Medical products/devices used
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 | NL72872.018.20 |