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

Overseen By Margaret Marcon, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Must not be taking: Anticoagulants

Disqualifiers: Esophageal stricture, Portal hypertension, Solid organ transplantation, Bleeding diathesis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if the CytospongeTM, a small sponge in a capsule, can safely and effectively collect tissue samples from the esophagus in children and teens with a specific condition. The goal is to see if it can replace traditional methods, which are more invasive. The sponge collects tissue as it is pulled back up after swallowing. The Cytosponge is a minimally invasive device developed to collect esophageal tissue samples.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on anticoagulation therapy, you may not be eligible to participate.

Is the Cytosponge safe for human use?

The Cytosponge, a device used to sample cells from the esophagus, has been shown to be safe and well-accepted by patients in various studies. It involves swallowing a capsule that dissolves to release a sponge, which collects cells as it is pulled out. Studies have reported high patient acceptability and no significant safety concerns. ^{1 2 3 4 5}

How does this esophageal sampling treatment differ from other methods?

This treatment uses a novel esophageal balloon with debriding strips for sampling, which allows for more precise site localization and potentially faster procedures compared to traditional brush biopsy and blind balloon sampling methods. ^{1 3 4 6 7}

Research Team

Margaret Marcon, MD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

Inclusion Criteria

10 to 18 years of age

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)

Exclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the Cytosponge procedure and traditional endoscopy for histological comparison

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedures

1 week

1 visit (in-person)

Treatment Details

Interventions

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

Participant Groups

Group I: Histology Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Findings from Research

The Cytosponge is a novel, patient-friendly device designed to efficiently sample the esophageal mucosa, showing promising results in detecting esophageal conditions compared to traditional endoscopy and biopsy methods.

High patient acceptability and the potential to reduce the need for costly endoscopic surveillance make the Cytosponge a significant advancement in the early detection of esophageal pathology, pending further validation in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a minimally invasive cell sampling device ('Cytosponge') in the diagnosis of esophageal pathology: a systematic review. Iqbal, U., Siddique, O., Ovalle, A., et al.[2019]

Sponge cytology is a highly effective and safe method for obtaining esophageal specimens, with 100% success in swallowing the sponge and satisfactory evaluation material from all participants.

The results showed that 86.6% of smears were negative for lesions, while 10% showed intestinal metaplasia, and 1.7% indicated high-grade lesions or squamous cell carcinoma, demonstrating good agreement with endoscopic findings and suggesting its potential as a primary screening tool in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esophageal cytology sponge diagnostic test results in kenyatta national referral hospital, kenya. Muriithi, RW., Muchiri, LW., Lule, GN.[2014]

References

1. England pubmed.ncbi.nlm.nih.gov

Regional variation in distal esophagus distensibility assessed using the functional luminal imaging probe (FLIP). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Minimally invasive esophageal sponge cytology sampling is feasible in a Tanzanian community setting. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Elastic plastic tube for detecting exfoliative cancer cells in the esophagus. [2004]

4. United States pubmed.ncbi.nlm.nih.gov

Directed balloon cytology of the esophagus: A novel device for obtaining circumferential cytologic sampling. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a minimally invasive cell sampling device ('Cytosponge') in the diagnosis of esophageal pathology: a systematic review. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Esophageal cytology sponge diagnostic test results in kenyatta national referral hospital, kenya. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Morphometric histology for infant gastroesophageal reflux disease: evaluation of reliability in 497 esophageal biopsies. [2007]