Capsule Sponge Study in Eosinophilic Oesophagitis

NCT06501274 | Recruiting DMC

• 1 other identifier: RD2022-43 314770
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Open pragmatic, descriptive single site study in adult patients with non-stenotic eosinophilic oesophagitis. To assess the clinical value of Capsule sponge in the assessment of treatment response in patients with known non-stenosing eosinophilic oesophagitis, as an alternative to gastroscopy in a real world setting. To assess patient preference for Capsule sponge or gastroscopy. All patients with non-stenosing eosinophilic oesophagitis who are reviewed in clinic that have not had reassessment of their oesophagus post treatment initiation or change in treatment will be offered Capsule sponge as an alternative to gastroscopy. A standardised clinical symptom questionnaire will be self-administered for 2w prior to clinic visits and Capsule sponge. Telephone triage for safety check and exclusion criteria by Capsule sponge nurse. A patient symptom questionnaire at the time of procedure by research nurse. A patient satisfaction survey will be delivered after the Capsule sponge procedure by Capsule sponge nurse. Cytological assessment of the Capsule sponge and eosinophil count and other markers of inflammation will be reported by Cyted. Clinic follow up will occur at approximately 6-8 weeks post Capsule sponge. Descriptive Changes in management as a result of the Capsule sponge findings and /or symptoms will be recorded by clinician.

Conditions

Eosinophilic Esophagitis

Keywords

capsule sponge

Outcome Measures

Primary Outcomes (5)

• • Descriptive Changes in clinical management of EOE following Capsule sponge assessment

  has the results of the capsule sponge resulted in a decision to change treatment drug, or drug dose?-yes/ no response

  through study completion, an average of 1 year

• • symptom score

  Dysphagia symptom score (DSQ) scored as continuous variable in 2 weeks prior to capsule sponge

  through study completion, an average of 1 year

• • Eosinophil count on cytology

  no of eosinophils per high powered field on cytology

  through study completion, an average of 1 year

• • Patient pain evaluation

  wong -baker faces visual scale from 0 to 10 with 0 being no pain and 10 being maximum pain

  through study completion, an average of 1 year

• patient preference for endoscopy or capsule sponge

  tick box

  through study completion, an average of 1 year

Secondary Outcomes (5)

• • Failure to swallow rate

  through study completion, an average of 1 year

• • Inadequate sample rate

  through study completion, an average of 1 year

• • Complications

  through study completion, an average of 1 year

• • Repeat gastroscopy rate

  through study completion, an average of 1 year

• Cost evaluation

  at end of study at 2 years

Study Arms (1)

all eligible patients with non stenotic eosinophilic oesophagitis

OTHER

single arm observational study

Device: capsule sponge

Interventions

capsule sponge DEVICE

capsule sponge sampling device of the oesophagus

all eligible patients with non stenotic eosinophilic oesophagitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients diagnosed with non -stenotic eosinophilic oesophagitis who have a change in treatment

You may not qualify if:

• Strictures or rings at most recent endoscopy that prevent passage of adult gastroscope
• Previous oesophageal dilatation
• Previous oesophageal perforation or surgical resection
• Oesophago-gastric malignancy
• Oesophageal varices
• Bolus obstruction since last endoscopy requiring hospital visit
• Previous fundoplication or complicated hiatus hernia
• Patient on Warfarin with INR\>=3
• Suspected new diagnosis of EOE without prior endoscopic confirmation

Sponsors & Collaborators

• East and North Hertfordshire NHS Trust: lead

Study Sites (1)

East and North Herts NHS Trust

Stevenage, Hertfordshire, SG1 4AB, United Kingdom

RECRUITING

Related Publications (8)

• Dhar A, Haboubi HN, Attwood SE, Auth MKH, Dunn JM, Sweis R, Morris D, Epstein J, Novelli MR, Hunter H, Cordell A, Hall S, Hayat JO, Kapur K, Moore AR, Read C, Sami SS, Turner PJ, Trudgill NJ. British Society of Gastroenterology (BSG) and British Society of Paediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN) joint consensus guidelines on the diagnosis and management of eosinophilic oesophagitis in children and adults. Gut. 2022 Aug;71(8):1459-1487. doi: 10.1136/gutjnl-2022-327326. Epub 2022 May 23.

  PMID: 35606089 BACKGROUND

• di Pietro M, Modolell I, O'Donovan M, Price C, Pilonis ND, Debiram-Beecham I, Fitzgerald RC. Use of Cytosponge as a triaging tool to upper gastrointestinal endoscopy during the COVID-19 pandemic. Lancet Gastroenterol Hepatol. 2020 Sep;5(9):805-806. doi: 10.1016/S2468-1253(20)30242-9. Epub 2020 Jul 30. No abstract available.

  PMID: 32738939 BACKGROUND

• Paterson AL, Lao-Sirieix P, O'Donovan M, Debiram-Beecham I, di Pietro M, Miremadi A, Attwood SE, Walter FM, Sasieni PD, Fitzgerald RC; BEST and BEST2 study groups. Range of pathologies diagnosed using a minimally invasive capsule sponge to evaluate patients with reflux symptoms. Histopathology. 2017 Jan;70(2):203-210. doi: 10.1111/his.13039. Epub 2016 Oct 12.

  PMID: 27417524 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

• Swart N, Maroni R, Muldrew B, Sasieni P, Fitzgerald RC, Morris S; BEST3 Consortium. Economic evaluation of Cytosponge(R)-trefoil factor 3 for Barrett esophagus: A cost-utility analysis of randomised controlled trial data. EClinicalMedicine. 2021 Jun 18;37:100969. doi: 10.1016/j.eclinm.2021.100969. eCollection 2021 Jul.

  PMID: 34195582 BACKGROUND

• Hudgens S, Evans C, Phillips E, Hill M. Psychometric validation of the Dysphagia Symptom Questionnaire in patients with eosinophilic esophagitis treated with budesonide oral suspension. J Patient Rep Outcomes. 2017;1(1):3. doi: 10.1186/s41687-017-0006-5. Epub 2017 Sep 12.

  PMID: 29757322 BACKGROUND

• Dellon ES, Irani AM, Hill MR, Hirano I. Development and field testing of a novel patient-reported outcome measure of dysphagia in patients with eosinophilic esophagitis. Aliment Pharmacol Ther. 2013 Sep;38(6):634-42. doi: 10.1111/apt.12413. Epub 2013 Jul 9.

  PMID: 23837796 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

• Danielle Morris, MD FRCP

  East and North Herts NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Toral Odedra

CONTACT

01438 314333; toral.odedra@nhs.net

Toral Odedra

CONTACT

toral.odedra@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: July 15, 2024
• Study Start: July 31, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)