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

NCT05342168 | Unknown DMC

• 1 other identifier: 10000073082
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

cytosponge; esophageal biopsy; Histology

Outcome Measures

Primary Outcomes (1)

• Eosinophil count per high power field obtained from Cytosponge supernant and endoscopic esophageal biopsies will be compared

  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 Outcomes (3)

• Likert scale (10 point) evaluating patient and caregiver satisfaction

  immediately following the endoscopy procedure

• Questionairre evaluating Patient and caregiver satisfaction

  immediately following endoscopy procedure

• Histology comparison of supernant obtained from sponge and esophageal pinch biopses

  one week

Study Arms (1)

Histology

EXPERIMENTAL

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

Interventions

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

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.

Also known as: Cytosponge

Histology

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Sickkids

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

Related Publications (5)

• Katzka DA, Geno DM, Ravi A, Smyrk TC, Lao-Sirieix P, Miremadi A, Debiram I, O'Donovan M, Kita H, Kephart GM, Kryzer LA, Camilleri M, Alexander JA, Fitzgerald RC. Accuracy, safety, and tolerability of tissue collection by Cytosponge vs endoscopy for evaluation of eosinophilic esophagitis. Clin Gastroenterol Hepatol. 2015 Jan;13(1):77-83.e2. doi: 10.1016/j.cgh.2014.06.026. Epub 2014 Jul 3.

  PMID: 24997328 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 BACKGROUND

• Januszewicz W, Tan WK, Lehovsky K, Debiram-Beecham I, Nuckcheddy T, Moist S, Kadri S, di Pietro M, Boussioutas A, Shaheen NJ, Katzka DA, Dellon ES, Fitzgerald RC; BEST1 and BEST2 study investigators. Safety and Acceptability of Esophageal Cytosponge Cell Collection Device in a Pooled Analysis of Data From Individual Patients. Clin Gastroenterol Hepatol. 2019 Mar;17(4):647-656.e1. doi: 10.1016/j.cgh.2018.07.043. Epub 2018 Aug 9.

  PMID: 30099104 BACKGROUND

• Benaglia T, Sharples LD, Fitzgerald RC, Lyratzopoulos G. Health benefits and cost effectiveness of endoscopic and nonendoscopic cytosponge screening for Barrett's esophagus. Gastroenterology. 2013 Jan;144(1):62-73.e6. doi: 10.1053/j.gastro.2012.09.060. Epub 2012 Oct 3.

  PMID: 23041329 BACKGROUND

• Dellon ES, Liacouras CA, Molina-Infante J, Furuta GT, Spergel JM, Zevit N, Spechler SJ, Attwood SE, Straumann A, Aceves SS, Alexander JA, Atkins D, Arva NC, Blanchard C, Bonis PA, Book WM, Capocelli KE, Chehade M, Cheng E, Collins MH, Davis CM, Dias JA, Di Lorenzo C, Dohil R, Dupont C, Falk GW, Ferreira CT, Fox A, Gonsalves NP, Gupta SK, Katzka DA, Kinoshita Y, Menard-Katcher C, Kodroff E, Metz DC, Miehlke S, Muir AB, Mukkada VA, Murch S, Nurko S, Ohtsuka Y, Orel R, Papadopoulou A, Peterson KA, Philpott H, Putnam PE, Richter JE, Rosen R, Rothenberg ME, Schoepfer A, Scott MM, Shah N, Sheikh J, Souza RF, Strobel MJ, Talley NJ, Vaezi MF, Vandenplas Y, Vieira MC, Walker MM, Wechsler JB, Wershil BK, Wen T, Yang GY, Hirano I, Bredenoord AJ. Updated International Consensus Diagnostic Criteria for Eosinophilic Esophagitis: Proceedings of the AGREE Conference. Gastroenterology. 2018 Oct;155(4):1022-1033.e10. doi: 10.1053/j.gastro.2018.07.009. Epub 2018 Sep 6.

  PMID: 30009819 BACKGROUND

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

Study Officials

• Margaret Marcon, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen Bortolin, MD

CONTACT

4168137735; kristen.bortolin@sickkids.ca

Margaret Marcon, MD

CONTACT

4168137735; peggy.marcon@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Each sample type is read by a pathologist blinded to the traditional ly obtained biopsy
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: cross sectional study comparing to tissue sampling methods

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 22, 2022
• Study Start: April 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)