Comparison of Histology From a Mesh Sponge and Traditional Esophageal Biopsies in Children and Adolescents With EoE

April 18, 2022 updated by: Margaret Marcon, The Hospital for Sick Children

Comparison of Histological Results Obtained From a Mesh Sponge (CytospongeTM) and Traditional Esophageal Mucosal Biopsies in Children and Adolescents With Eosinophilic Esophagitis

The aim of the present study is determining the accuracy, safety and tolerance of the CytospongeTM (expandable sponge within a gelatin capsule attached to a string) relative to traditional upper endoscopy and esophageal biopsies in older children and adolescents with a diagnosis of Eosinophilic Esophagitis (EoE) to follow up on treatment changes. The findings from this study could help determine whether the CytospongeTM is a more cost-effective alternative to traditional upper endoscopy for histologic follow-up in children and adolescents with EoE.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a cross-sectional study in pediatric subjects comparing histologic findings on esophageal biopsies obtained during upper GI endoscopies to histologic findings on tissue samples obtained through the use of the CytospongeTM in a group of paediatric patients with a diagnosis of EoE. Subjects will swallow the Cytosponge capsule (attached to a string) several hours prior to their scheduled endoscopy for treatment assessment. An esophageal sample will be obtained by withdrawing the expanded sponge thru the esophagus. This will be sent to pathology and fixed and stained. The subject will also undergo routine upper endoscopy under conscious sedation and follow up biopsies obtained as per routine standard of care to assess current treatment for EoE. There will be a blinded comparison between the biopsies and the Cytosponge sample by two pediatric pathologist with experience with EoE. Subjects and their caregivers will also be surveyed on their experience using the Cytosponge compared to having endoscopy.

This study has been performed in adults with Eosinophilic Esophagitis and found that the samples obtained with the Cytosponge was equivalent to the endoscopically obtained biopspes with out having to use endoscopy. Adult subjects also preferred the Sponge over having an endoscopy. The Cytosponge was shown to be safe and effected. Even larger adult trials in screening for esophageal cancer have shown the Cytosponge is safe and effective at sampling the esophagus.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previous histologic diagnosis of eosinophilic esophagitis (symptoms of esophageal dysfunction and at least 15 eosinophils per high-power field on esophageal biopsy and after a comprehensive assessment of non-EoE disorders that could cause or potentially contribute to esophageal eosinophilia).1
  • Capable of swallowing a capsule 3 cm in length (trial with 3 cm jelly candy).
  • 10 to 18 years of age.
  • Male or female.
  • Able to give assent or consent.
  • Scheduled for an upper gastrointestinal endoscopy with biopsies on the same day to assess response to therapy and make decisions regarding further management.

Exclusion Criteria:

  • Unable to swallow the capsule.
  • Unable to give assent or consent.
  • History of esophageal stricture on either upper gastrointestinal barium study or previous upper gastrointestinal endoscopy of food impaction that required removal.
  • History of portal hypertension or esophageal varices.
  • History of solid organ transplantation.
  • Known bleeding diathesis.
  • On anticoagulation therapy.
  • Known platelet count less than normal for age.
  • Pregnancy.
  • Need for intubation during endoscopy.
  • History of previous esophageal surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Histology
Specimen samples from the tradition pinch esophageal biopsy and the supernatant sample obtained from the mesh sponge (Cytosponge TM) will each be fixed and stained. The eosinophil count per high power field for the mesh sponge sample and the traditional biopsy sample will be compared for each subject.
Diagnostic test: Using a swallowed expanding sponge (Cytosponge TM) to obtain sampling of the esophageal musosa
A gelatin capsule containing the collapsed mesh sponge is swallowed with an attached string fixed to the cheek. After 8 minutes the gelatin capsule will have dissolved and the expanded soft mesh sponge can be with drawn sampling the surface of the esophagus on the way out. The sponge then will be spun and the supernant fixed, processed and stained.
Other Names:
  • Cytosponge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eosinophil count per high power field obtained from Cytosponge supernant and endoscopic esophageal biopsies will be compared
Time Frame: 1 week
Comparison of histology by counting the number of eosinophilis seen per high power field results from supernatant sample obtained via mesh sponge withdrawal thru the esophagus to samples obtained by the gold standard traditional esophageal biopsy.
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Likert scale (10 point) evaluating patient and caregiver satisfaction
Time Frame: immediately following the endoscopy procedure
Both patient and caregiver satisfaction will be assessed comparing the sponge method verses tradition upper will endoscopy with biopsy using a 10 point likert scale (1 to 10) with 10 being the better outcome.
immediately following the endoscopy procedure
Questionairre evaluating Patient and caregiver satisfaction
Time Frame: immediately following endoscopy procedure
Both patient and caregiver satisfaction will be assessed comparing the sponge method verses tradition upper will endoscopy with biopsy using a satisfaction questionnaire.
immediately following endoscopy procedure
Histology comparison of supernant obtained from sponge and esophageal pinch biopses
Time Frame: one week
Supernant samples and esophageal biopsies will be fixed and stained and then reviewed by the study pathologist to compare findings
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Margaret Marcon, MD, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

March 25, 2021

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 18, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10000073082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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