Diagnosis and Monitoring of Eosinophilic Esophagitis Using the Cytosponge

NCT02114606 | Terminated Results

• 1 other identifier: 13-3521
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief Summary

The current endoscopic methods for diagnosing and monitoring treatment response in Eosinophilic Esophagitis (EoE) are costly, inconvenient, and risky. Novel diagnostic methods are needed, and the minimally-invasive Cytosponge holds great promise. It has been shown to be safe and accurate in Barrett's esophagus, it has the advantage (over the string test) of obtaining a true tissue sample, and our preliminary data supports its further study in EoE. The proposed prospective cohort study, conducted by experts in esophageal diseases and EoE, will assess the accuracy of Cytosponge compared to endoscopy and biopsy in EoE, and determine the safety and acceptability of this technique. Use of the Cytosponge would fundamentally change the paradigm for clinical management of EoE by allowing collection of non-endoscopic esophageal biopsies, thus minimizing the need for invasive testing. It would also facilitate future genetic, mechanistic, and pathogenesis research in EoE.

Conditions

Eosinophilic Esophagitis; EoE

Keywords

Eosinophilic Esophagitis; EoE; Cytosponge

Outcome Measures

Primary Outcomes (1)

• Percent Agreement Between Cytosponge and Endoscopic Biopsy Results

  The primary outcome variables are sensitivity (percent agreement between positive results) and specificity (percent agreement between negative results) of the Cytosponge ability to detect the presence of EoE as compared to upper endoscopy with biopsy (the gold standard for diagnosis and monitoring of EoE). Overall agreement is defined as percentage of Cytosponge procedures yielding results consistent with endoscopic biopsy results. Presence of EoE is measured by the count of eosinophils present per high power field (eos/HPF) with active EoE defined as \>=15 eos/HPF. Sensitivity was calculated via percentage of positive (active EoE) results obtained via Cytosponge as compared to results indicating active EoE via endoscopy with biopsy. Specificity was calculated via percentage of negative (inactive EoE) results obtained via Cytosponge as compared to results indicating inactive EoE via endoscopy with biopsy.

  At study enrollment and initial procedure and each additional procedure, up to 1 year after enrollment

Secondary Outcomes (3)

• Overall Agreement Between Cytosponge and Endoscopic Biopsy Results as Measured by Kappa

  At study enrollment and initial procedure and each additional procedure, up to 1 year after enrollment

• Acceptability of Cytosponge Compared to Endoscopic Biopsy, as Measured by Visual Analog Scale

  7 days after each procedure

• Acceptability of Cytosponge as Measured by the Impact of Events Scale

  7 days after each procedure

Other Outcomes (1)

• Number of Responses Indicating Preference for Cytosponge Over Endoscopic Biopsy

  7 days after each procedure

Study Arms (1)

EoE Patients

EXPERIMENTAL

Patients who have been diagnosed with EoE as per recent guidelines will be enrolled. Samples will be obtained using the Cytosponge™ Cell Collection Device (Cytosponge) prior to participants' routine endoscopy with biopsy.

Device: Cytosponge™ Cell Collection Device

Interventions

Cytosponge™ Cell Collection Device DEVICE

The Cytosponge™ Cell Collection Device (Cytosponge) is intended to collect surface cells from the esophagus. The device consists of a swallowable capsule, which dissolves in the body cavity, releasing a self-expandable sponge. The sponge is then retrieved from the esophagus using an attached cord. During the retrieval process, the sponge collects cells from the most superficial layer of the esophageal mucosa. Once removed from the body cavity, the sponge and cells are retained for investigation and/or testing. The Cytosponge™ Cell Collection Device (Cytosponge) received 510(k) clearance from the FDA on November 26, 2014 (K142695). The Cytosponge ™ Cell Collection device is a Class II product under 21 CFR 874.4710 esophagoscope (flexible or rigid) and accessories.

Also known as: Cytosponge

EoE Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to read, comprehend, and complete the informed consent form
• Male or female subjects, age 18-80 years,
• Suspected EoE or has a diagnoses of EoE with current active disease,

You may not qualify if:

• History of esophageal stricture precluding passage of the endoscope or sponge,
• Pregnancy, or planned pregnancy during the course of the study,
• Any history of esophageal varices, liver impairment of moderate or worse severity (Child's- Pugh class B \& C) or evidence of varices noted on any past endoscopy,
• Any history of esophageal surgery, except for uncomplicated fundoplication
• History of coagulopathy, with international normalized ratio (INR) \>1.3 and/or platelet count of \<75,000.
• Current use of blood thinners such as coumadin, warfarin, clopidogrel, heparin and/or low molecular weight heparin (requires discontinuation of medication 7 days prior to and 7 days after esophagogastroduodenoscopy (EGD) and Cytosponge administration, aspirin use is OK).
• Are allergic to local anesthetics such as lidocaine (these subjects may opt not to receive the optional lidocaine gargle prior to the Cytosponge administration and still be eligible).
• Have not fasted the night before administration of the Cytosponge.
• History of perforation

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Mayo Clinic: collaborator
• University of Cambridge: collaborator
• CURED Foundation: collaborator

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

Related Publications (5)

• Hirano I, Moy N, Heckman MG, Thomas CS, Gonsalves N, Achem SR. Endoscopic assessment of the oesophageal features of eosinophilic oesophagitis: validation of a novel classification and grading system. Gut. 2013 Apr;62(4):489-95. doi: 10.1136/gutjnl-2011-301817. Epub 2012 May 22.

  PMID: 22619364 BACKGROUND

• Gonsalves N, Policarpio-Nicolas M, Zhang Q, Rao MS, Hirano I. Histopathologic variability and endoscopic correlates in adults with eosinophilic esophagitis. Gastrointest Endosc. 2006 Sep;64(3):313-9. doi: 10.1016/j.gie.2006.04.037.

  PMID: 16923475 BACKGROUND

• Dellon ES, Fritchie KJ, Rubinas TC, Woosley JT, Shaheen NJ. Inter- and intraobserver reliability and validation of a new method for determination of eosinophil counts in patients with esophageal eosinophilia. Dig Dis Sci. 2010 Jul;55(7):1940-9. doi: 10.1007/s10620-009-1005-z. Epub 2009 Oct 15.

  PMID: 19830560 BACKGROUND

• Dellon ES, Aderoju A, Woosley JT, Sandler RS, Shaheen NJ. Variability in diagnostic criteria for eosinophilic esophagitis: a systematic review. Am J Gastroenterol. 2007 Oct;102(10):2300-13. doi: 10.1111/j.1572-0241.2007.01396.x. Epub 2007 Jul 7.

  PMID: 17617209 BACKGROUND

• Katzka DA, Smyrk TC, Alexander JA, Geno DM, Beitia RA, Chang AO, Shaheen NJ, Fitzgerald RC, Dellon ES. Accuracy and Safety of the Cytosponge for Assessing Histologic Activity in Eosinophilic Esophagitis: A Two-Center Study. Am J Gastroenterol. 2017 Oct;112(10):1538-1544. doi: 10.1038/ajg.2017.244. Epub 2017 Aug 15.

  PMID: 28809387 RESULT

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

Due to device availability, this study was suspended indefinitely in June 2016. In August 2020, the decision was made to terminate the study early. The study population was limited to adult patients without critical strictures or small caliber esophagus.

Results Point of Contact

• Title: Evan Dellon, MD
• Organization: University of North Carolina at Chapel Hill

evan_dellon@med.unc.edu

919-966-2511

Study Officials

• Evan Dellon, MD, MPH

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 15, 2014
• Study Start: July 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 17, 2021
• Results First Posted: February 17, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)