Recruiting

Histology Comparison

Sponsor:

The Hospital for Sick Children

Code:

NCT05342168

Conditions

Eosinophilic Esophagitis

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

Interventions

Using a swallowed expanding sponge (Cytosponge TM) to obtain sampling of the esophageal musosa

Study Details

Brief summary:

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.

Conditions

Eosinophilic Esophagitis

Study ID

NCT05342168

Start date

Apr 1, 2022

Status verified date

Apr, 2022

Completion date

Sep 1, 2023

Anticipated

Primary completion date

Jul 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Eosinophil count per high power field obtained from Cytosponge supernant and endoscopic esophageal biopsies will be compared [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Kristen Bortolin, MD

4168137735kristen.bortolin@sickkids.ca

Margaret Marcon, MD

4168137735peggy.marcon@sickkids.ca

Locations

Sickkids

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Kristen Bortolin, MD

4168137735kristen.bortolin@sickkids.ca

Margaret Marcon, MD

14168135217peggy.marcon@sickkids.ca

Principal Investigator:

Jessie Hulst, MD

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Apr 22, 2022

Last verified

Apr, 2022

Keywords

  • cytosponge
  • esophageal biopsy
  • Histology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2022-04-22.