title: Accuracy, safety, and tolerability of tissue collection by Cytosponge vs endoscopy for evaluation of eosinophilic esophagitis.
abstract: OBJECTIVE
  Management of eosinophilic esophagitis (EoE) requires repeated endoscopic collection of mucosal samples to assess disease activity and response to therapy. An easier and less expensive means of monitoring of EoE is required. We compared the accuracy, safety, and tolerability of sample collection via Cytosponge (an ingestible gelatin capsule comprising compressed mesh attached to a string) with those of endoscopy for assessment of EoE.
  
  
  METHODS
  Esophageal tissues were collected from 20 patients with EoE (all with dysphagia, 15 with stricture, 13 with active EoE) via Cytosponge and then by endoscopy. Number of eosinophils/high-power field and levels of eosinophil-derived neurotoxin were determined; hematoxylin-eosin staining was performed. We compared the adequacy, diagnostic accuracy, safety, and patient preference for sample collection via Cytosponge vs endoscopy procedures.
  
  
  RESULTS
  All 20 samples collected by Cytosponge were adequate for analysis. By using a cutoff value of 15 eosinophils/high power field, analysis of samples collected by Cytosponge identified 11 of the 13 individuals with active EoE (83%); additional features such as abscesses were also identified. Numbers of eosinophils in samples collected by Cytosponge correlated with those in samples collected by endoscopy (r = 0.50, P = .025). Analysis of tissues collected by Cytosponge identified 4 of the 7 patients without active EoE (57% specificity), as well as 3 cases of active EoE not identified by analysis of endoscopy samples. Including information on level of eosinophil-derived neurotoxin did not increase the accuracy of diagnosis. No complications occurred during the Cytosponge procedure, which was preferred by all patients, compared with endoscopy.
  
  
  CONCLUSIONS
  In a feasibility study, the Cytosponge is a safe and well-tolerated method for collecting near mucosal specimens. Analysis of numbers of eosinophils/high-power field identified patients with active EoE with 83% sensitivity. Larger studies are needed to establish the efficacy and safety of this method of esophageal tissue collection. ClinicalTrials.gov number: NCT01585103.
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota. Electronic address: katzka.david@mayo.edu.
authors.forename: David A
authors.initials: DA
authors.lastname: Katzka
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Debra M
authors.initials: DM
authors.lastname: Geno
authors.affiliation: Division of Pulmonary Medicine, Mayo Clinic, Rochester, Minnesota.
authors.forename: Anupama
authors.initials: A
authors.lastname: Ravi
authors.affiliation: Department of Pathology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Smyrk
authors.affiliation: MRC Cancer Unit, Hutchinson/MRC Research Centre, University of Cambridge, Cambridge, United Kingdom.
authors.forename: Pierre
authors.initials: P
authors.lastname: Lao-Sirieix
authors.forename: Ahmed
authors.initials: A
authors.lastname: Miremadi
authors.affiliation: Department of Pathology, Addenbrooke's Hospital, Cambridge University NHS Foundation Trust, Cambridge, United Kingdom.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Miramedi
authors.affiliation: MRC Cancer Unit, Hutchinson/MRC Research Centre, University of Cambridge, Cambridge, United Kingdom.
authors.forename: Irene
authors.initials: I
authors.lastname: Debiram
authors.affiliation: Department of Pathology, Addenbrooke's Hospital, Cambridge University NHS Foundation Trust, Cambridge, United Kingdom.
authors.forename: Maria
authors.initials: M
authors.lastname: O'Donovan
authors.affiliation: Division of Pulmonary Medicine, Mayo Clinic, Rochester, Minnesota.
authors.forename: Hirohito
authors.initials: H
authors.lastname: Kita
authors.affiliation: Division of Pulmonary Medicine, Mayo Clinic, Rochester, Minnesota.
authors.forename: Gail M
authors.initials: GM
authors.lastname: Kephart
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Lori A
authors.initials: LA
authors.lastname: Kryzer
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Michael
authors.initials: M
authors.lastname: Camilleri
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Alexander
authors.affiliation: MRC Cancer Unit, Hutchinson/MRC Research Centre, University of Cambridge, Cambridge, United Kingdom.
authors.forename: Rebecca C
authors.initials: RC
authors.lastname: Fitzgerald
mesh_terms: D000328:Adult; D004724:Endoscopy / Q000009:adverse effects* / Q000379:methods*; D057765:Eosinophilic Esophagitis / Q000175:diagnosis*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009498:Neurotoxins / Q000032:analysis; D010336:Pathology / Q000379:methods*; D010342:Patient Acceptance of Health Care; D013048:Specimen Handling / Q000009:adverse effects* / Q000379:methods*; D013194:Staining and Labeling / Q000379:methods; D055815:Young Adult
chemical_list: D009498:Neurotoxins
keywords: Comparison; Eosinophilia; Inflammation; Response to Treatment