Accuracy and Safety of the Cytosponge for Assessing Histologic Activity in Eosinophilic Esophagitis: A Two-Center Study

David A Katzka, Thomas C Smyrk, Jeffrey A Alexander, Debra M Geno, RoseMary A Beitia, Audrey O Chang, Nicholas J Shaheen, Rebecca C Fitzgerald, Evan S Dellon, David A Katzka, Thomas C Smyrk, Jeffrey A Alexander, Debra M Geno, RoseMary A Beitia, Audrey O Chang, Nicholas J Shaheen, Rebecca C Fitzgerald, Evan S Dellon

Abstract

Objectives: Management of eosinophilic esophagitis (EoE) requires repeated endoscopic mucosal sampling to assess disease activity. A less invasive and expensive means of monitoring of EoE is required. The objective of this study was to assess the accuracy, safety, and tolerability of the cytosponge compared to endoscopy and biopsy for histologic assessment of EoE.

Methods: In this prospective two-center cross-sectional study, patients with known EoE underwent cytosponge sampling followed by endoscopy and biopsy. Sample adequacy and eosinophil counts (eos/HPF) were determined for both cytosponge and endoscopic samples. The cytosponge was assessed for diagnostic accuracy, safety, and patient preference as compared to endoscopy.

Results: Six patients (7%) failed to swallow the sponge. One hundred and five procedures were successfully performed in 80 patients (66% male, 100% white, 19% stricture). The cytosponge sample was adequate in 102 and the biopsy in 104; 101 procedures had adequate samples by both techniques. Fifty-seven biopsies were graded as active EoE with ≥15 eos/HPF as the gold standard. Eosinophil counts highly correlated between the biopsy and cytosponge (r=0.78, P<0.0001). Using a cutoff of ≤15 eos/HPF for inactive disease, the sensitivity and specificity of the cytosponge was 75% and 86%, respectively. Six patients had active EoE on cytosponge not found on biopsy. For biopsies with inactive EoE, the cytosponge identified 38/44. No complications occurred, and cytosponge endoscopic abrasion scores were low (0.34/4). Patients preferred cytosponge to endoscopy with higher rating scores (7.27 vs. 6.11, P=0.002).

Conclusions: Compared to endoscopy with biopsy, cytosponge provided a minimally invasive, safe, well tolerated, and accurate method to assess EoE histologic activity. (ClinicalTrial.gov number NCT01585103).

Conflict of interest statement

Guarantor of the article: .

Specific author contributions: D.A.K.: study design, data collection and analysis, and writing of the manuscript. T.C.S.: study design, data collection and analysis, and writing of the manuscript. D.M.G.: study design, data collection, and proofing of the manuscript. R.A.B.: data collection and proofing of the manuscript. A.U.C.: data interpretation and proofing of the manuscript. J.A.A.: study design, data collection, and proofing of the manuscript. R.C.F.: study design, writing, and proofing of the manuscript. E.S.D.: study design, data collection and analysis, and writing of the manuscript.

Financial support: This study was funded in part by a grant from the CURED Foundation (E.S.D.), AGA Covidien Award (D.A.K.), and NIH T35 DK007386 (A.O.C.).

Potential competing interests: E.S.D.: No potential competing interests related to this study. Consultant for Adare, Alivio, Banner, Celgene/Receptos, Regeneron, and Shire. Research funding from Meritage, Miraca, Nutricia, Celgene/Receptos, Regeneron, and Shire. Educational grant from Banner. D.A.K.: Consultant for Adare and Shire; research funding from AGA-Covidien Grant. J.A.A.: Consultant for Meritage Pharmacia, stock ownership Meritage Pharmacia. R.C.F.: Inventor on patents for the cytosponge. N.J.S.: Medtronic, CSA Medical, C2 Therapeutics, Boston Scientific, CDx Medical, and EndosStim. T.C.S., D.M.G., R.A.B., and A.U.C. declare no conflict of interest.

Figures

Figure 1
Figure 1
Histologic view of cytosponge fragments after processing. (a) Negative specimen. (b) Positive specimen (both at × 4).
Figure 2
Figure 2
Matched comparison of cytosponge and biopsy specimens. Comparison of cytosponge (a,c) and biopsy (b,d) specimens in matched patients with active (a,b) and inactive (c,d) eosinophilic esophagitis (× 40). In (a), filled arrows point to eosinophils, open arrows to spongiosis (dilated intercellular spaces).
Figure 3
Figure 3
Correlation of eosinophil counts per HPF on matched patients for cytosponge and biopsy specimens. Spearman’s Rho is reported.
Figure 4
Figure 4
Receiver operator characteristic curve for accuracy of cytosponge compared to a threshold of 15 eos/HPF on endoscopic biopsy for identification of active eosinophilic esophagitis. AUC, area under the curve.

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Source: PubMed

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