Eosinophilic Esophagitis
Conditions
Interventions
High resolution impedance manometry (HRIM)
Sponsors
Investigator initiated study by Amsterdam UMC, location AMC
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Age 12 years up to 19 years inclusive - Previous EGD with histological evidence of EoE (15 eosinophils per high power field) - Need for a routine clinical EGD
Exclusion criteria
Exclusion criteria: Any of the following contraindications for high resolution manometry: - insufficient knowledge of the Dutch or English language - Near complete obstruction - Severe coagulopathy - Cardiac conditions in which vagal stimulation is poorly tolerated - Oesophageal varices - Nasal septum deviation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The goal of our study is to assess diagnostic accuracy of CSI and/or change in CSI (at 5, 10 and 15 cm proximal to the upper border of the lower esophageal sphincter) for the presence of persistent active disease in pediatric EoE. Diagnostic accuracy parameters: - CSI and/or change in CSI (if applicable) - EGD histologic results (at least 15 eos/hpf (standard size of ~0.3mm2) - Positive predictive value, negative predictive value, sensitivity, specificity and likelihood ratios of CSI for o Presence of active disease o Presence of complete remission | — |
Secondary
| Measure | Time frame |
|---|---|
| - Inter- and intrarater variability of CSI - cross-validation - assess the patient burden of CSI and esophagogastroduodenoscopy and compare them using the DISCO questionnaire - cost effectiveness of HRIM vs esophagogastroduodenoscopy | — |
Contacts
Public ContactCarlijn Mussies
Emma Children’s Hospital/Academic Medical Centre
Outcome results
None listed