Accuracy, Safety, and Tolerability of Tissue Collection by Cytosponge vs Endoscopy for Evaluation of Eosinophilic Esophagitis

doi:10.1016/j.cgh.2014.06.026

Clinical Gastroenterology and Hepatology

Volume 13, Issue 1, January 2015, Pages 77-83.e2

https://doi.org/10.1016/j.cgh.2014.06.026 Get rights and content

Background & Aims

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.

Section snippets

Patients

Twenty adult patients with known EoE diagnosed in accordance with consensus guidelines¹ including a lack of histologic response to proton pump inhibitors were included. Patients with active disease (≥15 eosinophils per high-power field [eos/HPF]) or in remission (<15 eos/HPF) who were undergoing clinically indicated upper gastrointestinal endoscopy and esophageal biopsies were included. This endoscopy could be performed at initial diagnosis or after a standard 8-week course of treatment with

Patient Characteristics

A description of patients studied is given in Table 1. The age range was 22–51 years (median, 34 years). Eleven patients were men. All patients were white. Thirteen patients had active EoE by histology, whereas 7 patients were considered to be in remission according to the endoscopic biopsies. Fifteen patients had esophageal strictures. Thirteen patients had strictures or small-caliber esophagus (SCE) as assessed by calculation of minimal and maximal diameters on barium esophagography as

Discussion

In this study, the Cytosponge is a promising modality for measuring the activity of EoE in patients when compared with endoscopy and biopsy. Although it is called a Cytosponge, it in fact yields a histologic specimen. Furthermore, the utility of this approach was assessed through direct measurement of eosinophils in addition to staining for EDN. The Cytosponge was also shown to be easy and reliable to perform, yielded a robust cellular specimen irrespective of esophageal diameter, and was safe

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Citation Excerpt :
Towards this end, Cytosponge, a cell collection device, was developed for the collection and retrieval of surface cells in the esophagus and is currently being investigated in clinical studies [7–12]. The Cytosponge is composed of a compressed 30-mm polyurethane sponge attached to a string encased in an ingestible gelatin capsule [8–12]. However, the Cytosponge retrieval process has caused some serious issues arising from the detachment of the sponge from the removal string during withdrawal from the patient's esophagus and occasionally causing minor pharyngeal bleeds [13].
Accurate and rapid point-of-care tissue and microbiome sampling is critical for early detection of cancers and infectious diseases and often result in effective early intervention and prevention of disease spread. In particular, the low prevalence of Barrett's and gastric premalignancy in the Western world makes population-based endoscopic screening unfeasible and cost-ineffective. Herein, we report a method that may be useful for prescreening the general population in a minimally invasive way using a swallowable, re-expandable, ultra-absorbable, and retrievable nanofiber cuboid and sphere produced by electrospinning, gas-foaming, coating, and crosslinking. The water absorption capacity of the cuboid- and sphere-shaped nanofiber objects is shown ∼6000% and ∼2000% of their dry mass. In contrast, unexpanded semicircular and square nanofiber membranes showed <500% of their dry mass. Moreover, the swallowable sphere and cuboid were able to collect and release more bacteria, viruses, and cells/tissues from solutions as compared with unexpanded scaffolds. In addition to that, an expanded sphere shows higher cell collection capacity from the esophagus inner wall as compared with the unexpanded nanofiber membrane. Taken together, the nanofiber capsules developed in this study could provide a minimally invasive method of collecting biological samples from the duodenal, gastric, esophagus, and oropharyngeal sites, potentially leading to timely and accurate diagnosis of many diseases.
Recently, minimally invasive technologies have gained much attention in tissue engineering and disease diagnosis. In this study, we engineered a swallowable and retrievable electrospun nanofiber capsule serving as collection device to collect specimens from internal organs in a minimally invasive manner. The sample collection device could be an alternative endoscopy to collect the samples from internal organs like jejunum, stomach, esophagus, and oropharynx without any sedation. The newly engineered nanofiber capsule could be used to collect, bacteria, virus, fluids, and cells from the abovementioned internal organs. In addition, the biocompatible and biodegradable nanofiber capsule on a string could exhibit a great sample collection capacity for the primary screening of Barret Esophagus, acid reflux, SARS-COVID-19, Helicobacter pylori, and gastric cancer.

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: Conflicts of interest These authors disclose the following: Rebecca C. Fitzgerald and Pierre Lao-Sirieix have developed the Cytosponge technology that has been licensed by MRC-Technology to Covidien GI solutions. The device used in this study was a research prototype developed by the Medical Research Council, UK. Since the study was conducted, Pierre Lao-Sirieix has been employed by Covidien GI Solutions. The remaining authors disclose no conflicts.

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Original articleAlimentary tractAccuracy, Safety, and Tolerability of Tissue Collection by Cytosponge vs Endoscopy for Evaluation of Eosinophilic Esophagitis

Background & Aims

Methods

Results

Conclusions

Section snippets

Patients

Patient Characteristics

Discussion

J Allergy Clin Immunol

Gastroenterology

Gastrointest Endosc

Clin Gastroenterol Hepatol

Clin Gastroenterol Hepatol

Gastrointest Endosc

Eosinophilic esophagitis: updated consensus recommendations for children and adults

J Allergy Clin Immunol

Delay in diagnosis of eosinophilic esophagitis increases risk for stricture formation in a time-dependent manner

Gastroenterology

Original article
Alimentary tract
Accuracy, Safety, and Tolerability of Tissue Collection by Cytosponge vs Endoscopy for Evaluation of Eosinophilic Esophagitis