Cytosponge Study in Eosinophilic oesophagitis (CoSiE)
Research type
Research Study
Full title
A pragmatic interventional study to assess the clinical value of Cytosponge in the assessment of response to treatment of non-stenotic eosinophilic oesophagitis in a single district general hospital
IRAS ID
314770
Contact name
Danielle Morris
Contact email
Sponsor organisation
East and North Herts NHS Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Eosinophilic oesophagitis (EOE) is an allergic and inflammatory condition of the oesophagus that is increasing in incidence in the UK .It causes difficulty in swallowing (dysphagia) and often results in admission to hospital with food sticking (bolus obstruction) that requires removal with a tube down the mouth called a gastroscopy .
Evidence suggests that if inadequately treated there is increased risk of oesophageal narrowing of the oesophagus( called fibrosis and stricture formation) that can lead to worsening symptoms, food bolus obstruction and admissions to hospital to remove food blockages.
Current guidelines from Europe and new guidelines from the UK recommend reassessment of oesophageal inflammation (called eosinophilia) after treatment to ensure response.
This has previously involved repeating a gastroscopy and taking samples (biopsies) after each treatment which is unpleasant for patients, expensive and labour intensive.
The study aims to use an alternative to gastroscopy called a Cytosponge which is a cell collection device also described as the ‘sponge on the string’ test. This is a much less invasive , quicker and cheaper alternative to gastroscopy.
The study aims are
1. to observe the effects of Cytosponge on clinical decision making when used as an alternative to gastroscopy
2.To assess the clinical value of Cytosponge in the assessment of treatment response in patients with known non-stenosing eosinophilic oesophagitis as an alternative to gastroscopy.
3.To assess the patient satisfaction and preference for Cytosponge or gastroscopy
The study will take place in a non-specialist secondary care setting where Cytosponge is being used extensively in the investigation of other oesophageal conditions: Barrett’s oesophagus and Gastro-oesophageal reflux. The study aims to recruit 50-70 patients per year with EOE, 100-140 patients over a 2 year period.
The study is supported by Dr Falk Pharma who manufacture a licensed treatment for EOE and Cyted who supply and process the cytosponge.REC name
Wales REC 1
REC reference
23/WA/0091
Date of REC Opinion
11 Apr 2023
REC opinion
Further Information Favourable Opinion