Are tests of oesophageal (food pipe) function useful and acceptable to patients with eosinophilic oesophagitis?
- Conditions
- Eosinophilic oesophagitisDigestive System
- Registration Number
- ISRCTN17786884
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 60
1. Patients from County Durham and Darlington NHS Foundation Trust (CDDFT) or University College London Hospitals (UCLH)
2. Aged 18 years or over
3. New diagnosis of eosinophilic oesophagitis (>15/high-powered field (hpf) or 0.3 mm² on oesophageal biopsy and index oesophageal symptoms
4. Known diagnosis of eosinophilic oesophagitis (current histological and symptom status documented but does not impact inclusion)
1. <18 years old
2. Current involvement in a Clinical Trial of an Investigational Medicinal Product (CTIMP) for eosinophilic oesophagitis (EoE)
3. Eosinophilia as a result of other known causes (local or systemic)
4. Oesophageal stricture on oesophagogastric duodenoscopy
5. Previous upper GI surgery
6. Active oesophageal comorbidity including Barrett’s oesophagus, oesophageal varices, coagulation disorders
7. Significant nasopharyngeal pathology, preventing nasogastric intubation
8. Opiate use
9. Unable to provide informed consent
10. Limited verbal communication
11. Non English speaker
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Recruitment rate, recorded as the number of eligible participants who consent to participate in the study during the 21-month recruitment period <br>2. Attrition rate, assessed using the number of consented participants who do not remain in the study until the end of follow-up, defined as completing physiological assessments on visit 1 (single day) and where new medication is initiated, repeat investigations 2-4 months following this
- Secondary Outcome Measures
Name Time Method