Sponge and Eosinophil Peroxidase (EPO) Staining

Study Overview
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Brief Summary
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Are we able to use the EPO staining technique using the sponge ?

Detailed Description
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EPO staining on esophageal sponge samples had a strong association with peak esophageal eosinophil counts on endoscopic biopsy specimens in a small study of 26 patients Using a cut-off of 1.1 absorbance units in a colorimetric assay at a wavelength of 492nm the EPO stain had sensitivity and specificity of 1105 and 83% respectively for a peak eosinophil count of 15 eos/hpf on histologic endoscopic obtained biopsy specimens. The technique of EPO staining is standardized and can be completed in 45 minutes time. Currently, we have found esophageal sponge cytology sensitive and specific for assessment of esophageal eosinophilia. It allows disease activity assessment without endoscopy is much preferred by patients over the standard endoscopic technique of disease assessment. The process of specimen preparation in fairly tedious and interpretation takes significant experience. If EPO staining on non-endoscopic esophageal sponge studies was accurate at assessing disease activity, this is a tool that could be easily performed and interpreted with a rapid turnaround time.

Official Title
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Is EPO Staining on Esophageal Sponge Samples a Simple Reliable Method of Accessing Esophageal Eosinophilia?

Conditions
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Eosinophilic Esophagitis

Intervention / Treatment
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* Device: swallowed sponge device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 70 years of age Diagnosed with Eosinophilic Esophagitis > than 15 Eos phf and failed to respond to the PPI therapy Going through the six food elimination diet or have just completed elimination the six foods: fish, nuts, eggs, soy, wheat, and milk Exclusion Criteria: Clinical evidence of infectious process potentially contributing to dysphagia (e.g. candidiasis, CMV, herpes) Other cause of dysphagia identified at endoscopy (e.g. reflux esophagitis, stricture, web, ring, achalasia, esophageal neoplasm) Esophageal minimal diameter < 13 mm on structured barium esophagram

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: swallowed sponge device<br>Swallowing a sponge prior to a clinical upper endoscopy. Patients diagnosed with Eosinophilic Esophagitis (EoE) > than 15 Eosinophils per high power field (phf) and failed to respond to Proton Pump Inhibitors (PPI) therapy. Will be asked to swallow a sponge, this is a 10 minute procedure done in the office prior to their clinical upper endoscopy. This will be sent for histology, >15 Eos phf would be considered active disease. We will compare the results of the sponge using the EPO staining technique compared to histologic response. | Device: swallowed sponge device<br>* Swallowed sponge: Subjects having a clinical upper endoscopy will be asked to swallow the sponge 2 hours prior to EGD<br>* Other names: brush;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sponge pathology verses biopsy results: number of eosinophils | Patients will swallow the sponge prior to a clinical upper endoscopy with biopsies. We will compare upper endoscopy biopsies to the pathology from the cytosponge using the EPO staining technique. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EoE