Eosinophilic Esophagitis Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Sickkids | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children |
Canada,
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. Erratum in: Clin Gastroenterol Hepatol. 2015 Aug;13(8):1552. Miramedi, Ahmed [corrected to Miremadi, Ahmed]. — View Citation
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. Erratum in: Am J Gastroenterol. 2017 Dec 19;:. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Likert scale (10 point) evaluating patient and caregiver satisfaction | 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 | |
Secondary | Questionairre evaluating Patient and caregiver satisfaction | 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 | |
Secondary | Histology comparison of supernant obtained from sponge and esophageal pinch biopses | Supernant samples and esophageal biopsies will be fixed and stained and then reviewed by the study pathologist to compare findings | one week |
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