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Sponge and Eosinophil Peroxidase (EPO) Staining

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03078023
Enrollment
25
Registered
2017-03-13
Start date
2017-03-08
Completion date
2019-07-19
Last updated
2022-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

Keywords

EoE

Brief summary

Are we able to use the EPO staining technique using the sponge ?

Detailed description

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.

Interventions

DEVICEswallowed sponge device

Swallowed sponge: Subjects having a clinical upper endoscopy will be asked to swallow the sponge 2 hours prior to EGD

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sponge pathology verses biopsy results: number of eosinophils1 yearPatients 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026