Endoscopic Characterisation of Inflammation in EoE

Eosinophilic Esophagitis Clinical Trial

— ECI-EoE  

Official title:

Endoscopic Characterisation of Inflammatory Activity in EoE: Comparison of Two Gastroscopes With High Magnification to the Goldstandard Histology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04769232
• Other study ID #: 2020-00817
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2021
• Est. completion date: November 2021

Study information

• Verified date: February 2021
• Source: University of Zurich
• Contact: Bernhard Morell
• Phone: 0041442551111
• Email: bernhard.morell[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, we plan to investigate the accuracy of the EG-760Z endoscope (135x zoom) compared with standard imaging with histology as gold standard in detecting and grading inflammatory activity in patients with eosinophilic esophagitis (EoE).

Description:

Eosinophilic esophagitis (EoE) is a chronic-inflammatory disease of the esophagus. If left untreated, eosinophilic inflammation induces fibrosis, angiogenesis and stricture formation, finally resulting in a so called remodelling with structural and functional damage of the organ. In addition, patients with untreated EoE are permanently at risk of experiencing food impactions. It is therefore widely accepted that active EoE should be recognized and treated as such. Any treatment applied in EoE should ideally achieve two therapeutic goals: first, resolution of symptoms, and, second, control of inflammation. However, in some cases of EoE, there is a dissociation between symptoms and histological response. Furthermore, characteristic endoscopic findings may occur together but are not all seen in every EoE patient. As an example, in 7% to 10% of cases the esophagus may appear normal. Lastly, inflammatory infiltration of the esophageal wall may be discontinuous. In order to define endoscopic activity of EoE in a standardized fashion, the endoscopic reference score (EREFS) is usually applied. Several endoscopic findings, including linear furrows, concentric rings, white exudates, decreased vasculature in the esophageal mucosa, esophageal strictures, and the esophagus of narrow caliber have been reported to be the characteristic findings of EoE, although neither of these is specific. According to a meta-analysis from 2012, consisting primarily of retrospective studies involving adult cohorts, the overall pooled prevalence of endoscopic findings in patients with EoE was 44% rings, 21% strictures, 9% narrow caliber esophagus, 48% linear furrows, 27% white exudates, and 41% decreased vascularity, with a wide variation in the prevalence of those endoscopic findings between each report. Lastly, inflammatory infiltration of the esophageal wall may be discontinuous. Taken together, endoscopic recognition of EoE remains a major clinical challenge and diagnosis still relies on histological sampling which in turn renders the diagnosis prone to sampling errors. In addition to that, it is well known that optimal control of inflammatory activity is crucial in order to prevent progression of fibrosis. Therefore, monitoring inflammatory activity (determined by the EoE histologic scoring system; EoE-HSS) is part of clinical routine in patients with EoE. As outlined above, endoscopic assessment, however, does not reliably reflect the underlying process of the disease during the index endoscopy and cannot be regarded as reliable follow-up test. The investigators hypothesize that novel endoscopic technologies overcome the shortcomings of the standard endoscopic imaging. It is therefore planned to compare images of the esophageal mucosa using the EG-760Z endoscope by Fujifilm (Fujifilm Europe, Düsseldorf, Germany) to standard imaging with high magnification imaging. This novel endoscope acquires images with a magnification by a factor of 135. As gold standard, histological assessment of the inflammatory activity will be used.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Eosinophilic Esophagitis
• Esophagitis

Intervention

Device:
• EG-760Z endoscope by Fujifilm
Within a single endoscopic procedure under propofol sedation, images of the esophageal wall will be acquired and biopsies will be taken. All patients will be examined using the EG-760Z endoscope by Fujifilm. In all patients as part of the clinical routine 4 biopsies of the proximal and 4 biopsies of the distal esophagus will be taken.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

References & Publications (3)

Bisschops R, Hassan C, Bhandari P, Coron E, Neumann H, Pech O, Correale L, Repici A. BASIC (BLI Adenoma Serrated International Classification) classification for colorectal polyp characterization with blue light imaging. Endoscopy. 2018 Mar;50(3):211-220. doi: 10.1055/s-0043-121570. Epub 2017 Oct 24. — View Citation

Kim HP, Vance RB, Shaheen NJ, Dellon ES. The prevalence and diagnostic utility of endoscopic features of eosinophilic esophagitis: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Sep;10(9):988-96.e5. doi: 10.1016/j.cgh.2012.04.019. Epub 2012 May 18. Review. — View Citation

Straumann A. Medical therapy in eosinophilic oesophagitis. Best Pract Res Clin Gastroenterol. 2015 Oct;29(5):805-814. doi: 10.1016/j.bpg.2015.06.012. Epub 2015 Jul 26. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High magnification leeds to more accurate histologic sampling	High magnification by a factor of 135, using the EG-760Z endoscope by Fujifilm, enables biopsies in areas with higher degree of inflammation.; Biopsies will be analyzed by an experienced pathologist in the field of EoE. The pathologist will count the number of eosinophilic neurtophils in a high-power field (HPF). The absolut number of eosinophilic neutrophils per HPF will be compared to biopsies taken with standard imaging.	6 months
Secondary	Target biopsies are non-inferior to standard biopsies	Target single biopsies with high magnification by a factor of 135, using the EG-760Z endoscope by Fujifilm, in the proximal and distal esophagus are non-inferior to goldstandard biopsies taken with a standard endoscope (4 biopsies proximally and distally) in disease monitoring.; Biopsies will be analyzed by an experienced pathologist in the field of EoE. The pathologist will count the number of eosinophilic neurtophils in a high-power field (HPF). The absolut number of eosinophilic neutrophils per HPF will be compared to biopsies taken with standard imaging.	6 months

External Links

•   Clinical investigation of medical devices for human subjects -- Good clinical practice