Pilot Study of EsoCheck Compared to Biopsies and Brush Cytology During Endoscopy for Evaluation of Eosinophilic Esophagitis.

Background Eosinophilic esophagitis (EoE) is a chronic inflammatory condition of the esophagus characterized by esophageal eosinophilia that can lead to esophageal remodeling and stricture formation. To assess remission, upper endoscopy (EGD) with biopsies is performed. This is an invasive procedure and contributes to cost burden for patients. It is important to assess non-invasive techniques to sample the cells of the esophagus.

There have been a few non-invasive testing modalities suggested, including the esophageal string test and Cytosponge. These involve swallowing a string or capsule that ultimately collects esophageal cells. The string test study showed a significant correlation with traditional biopsy pathology, however, limitations included the string remaining in overnight and potential contamination from oral flora. Katzka et al showed that the Cytosponge had an 86% specificity with limitations including gelatin allergy, local esophageal abrasions and similar potential oral contamination as the esophageal string test.

Another promising device is EsoCheck. This is an encapsulated balloon that can be easily swallowed and collect cells from the distal esophagus. It is well tolerated and, in Barrett's esophagus, detected metaplasia with 91.7% specificity. The primary aims of this study are to determine the feasibility and safety of EsoCheck compared with standard endoscopy and biopsies in the assessment of EoE. Secondary aims include specific and sensitivity of EsoCheck as well as specificity and sensitivity of brush cytology given that EsoCheck is a cytology device.

Detailed Description Study design This is a prospective pilot study at the University of Pennsylvania to evaluate feasibility and safety. Inclusion criteria include patients at least 22 years of age with known EoE diagnosed in accordance with consensus guidelines previously scheduled upper endoscopy at the University of Pennsylvania. Exclusion criteria include: known or suspected contraindication for esophageal intubation, esophageal stricture with inability to pass an endoscope, history of esophageal perforation, history of esophageal resection, esophageal diverticula, esophageal fistula, pill dysphagia, pill swallowing phobia, food impaction, esophageal varices, coagulopathy, active anticoagulation or antithrombotics, active GI bleeding and pregnancy.

Consecutive patients will be approached for consent until a total of 20 patients are enrolled. Patients will be approached during the same clinic visit if they meet inclusion criteria that arranges for the EGD or via telephone up to 2 weeks prior to scheduled EGD. Charts will be reviewed and patients will be asked medical and surgical history questions to assess if any exclusion criteria. Written consent will be obtained on the day of endoscopy. Charts will be reviewed and patients called at 1 week follow up to assess if any adverse events.