Endoscopic Characterisation of Inflammation in EoE (ECI-EoE)
Eosinophilic Esophagitis
About this trial
This is an interventional diagnostic trial for Eosinophilic Esophagitis
Eligibility Criteria
Inclusion Criteria:
Eligible are patients with histology-proven EoE in whom a follow-up endoscopy is indicated. Indications for follow-up endoscopy are i) determination of the response to PPI-Trial or ii) inadequate symptomatic relief despite established therapy.
Type of treatment, or response to, have no implications on eligibility.
Participants fulfilling all of the following inclusion criteria are eligible for the study:
- Patient is capable of giving informed consent
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Have histology proven EoE and are due to undergo follow-up gastroscopy or are due to undergo gastroscopy to investigate dyspepsia (control group)
- Male and Female patients 18 years to 80 years of age
Exclusion Criteria:
- Contraindications to outpatient gastroscopy
- Contraindication for Non-anesthesia Provider Procedural Sedation and Analgesia: ASA class III or higher, morbid obesity (BMI > 40 kg/m^2), severe OSAS
- Contraindications to tissue sampling: oral anticoagulation in combination with antiaggregant such as aspirin or clopidogrel,
- Patients without subcutaneous veins that allow for insertion of peripheral venous catheters
- Women who are pregnant or breast feeding
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
- Participation in another study with investigational drug/device within the 30 days preceding and during the present study
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard Imaging
High Magnification Imaging
In 20 randomly assigned patients, the area of endoscopically highest activity will be biopsied as determined by standard imaging. A total of 10 biopsies will be taken in 4 sets: 1 = one single biopsy at best guess of highest activity; 2 = one single biopsy at second best guess of highest activitiy, 3 = 4 biopsies in proximal esophagus with presumed activity, 4 = 4 biopsies in distal esophagus with presumed activity. Overall qualitative (eosinophilic inflammation present vs. absent) and semi-quantitative (estimation of the number of eosinophilic neutrophils according to the following categories 1: 0, 2: 1-6, 3. 7-14, 4. 15-50, 5. :50-100, 6. > 100, together with an estimation of an absolute number of eosinophilic neutrophils) inflammatory activity will be rated for the presumed localization of maximal histologic activity and subsequently for all other 10 biopsies using this imaging modality by endoscopist.
In 20 randomly assigned patients, the area of endoscopically highest activity will be biopsied as determined by high magnification imaging. A total of 10 biopsies will be taken in 4 sets: 1 = one single biopsy at best guess of highest activity; 2 = one single biopsy at second best guess of highest activitiy, 3 = 4 biopsies in proximal esophagus with presumed activity, 4 = 4 biopsies in distal esophagus with presumed activity. Overall qualitative (eosinophilic inflammation present vs. absent) and semi-quantitative (see above) inflammatory activity will be rated for the presumed localization of maximal histologic activity and subsequently all other 10 biopsies using this imaging modality by endoscopist.