Eosinophilic oesophagitis Digestive System
Conditions
Interventions
High-resolution manometry (HRM) testing forms the initial part of this serial diagnostic study, assessing oesophageal function during eating in patients with EoE. Comparison will be made to diagnostic
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate, recorded as the number of eligible participants who consent to participate in the study during the 21-month recruitment period 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
| Measure | Time frame |
|---|---|
| 1. Swallowing parameters measured whilst participants eat a solid test meal using high-resolution manometry at visit 1/baseline (before any new treatment is instigated as part of routine clinical care) and at 2-4 months after a new treatment is instigated as part of routine clinical care where applicable 2. Temporal relationship between symptoms and swallowing parameters measured using high-resolution manometry during the solid test meal consumption both at visit 1/baseline and 2-4 months after a new treatment is instigated as part of routine clinical care where applicable 3. Mean nocturnal baseline impedance of the oesophageal mucosa measured using 24-hour ambulatory pH/impedance testing at visit 1/baseline (before a new treatment is instigated as part of routine clinical care) and at 2-4 months after a new treatment is instigated as part of routine clinical care where applicable 4. Gastro-oesophageal reflux exposure measured using 24-hour ambulatory pH/impedance testing at visit 1/baseline (before a new treatment is instigated as part of routine clinical care) and 2-4 months after a new treatment is instigated as part of routine clinical care where applicable 5. Dysphagia, reflux symptoms and oesophageal hypervigilance and anxiety measured using the Brief Esophageal Dysphagia Questionnaire, Reflux Disease Questionnaire and the Esophageal Hypervigilance and Anxiety Scale respectively, at visit 1 and 2-4 months after a new treatment is initiated (where applicable) 6. Routine markers of eosinophilic oesophagitis (e.g. histology, endoscopic appearances) measured as part of routine care will be compared to study findings from closest visits, e.g. baseline endoscopy compared to baseline tests and follow-up endoscopy 2-4 months after treatment initiation compared to follow-up tests | — |
Countries
England, United Kingdom
Outcome results
None listed