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Endoscopic Characterisation of Inflammation in EoE (ECI-EoE)

Primary Purpose

Eosinophilic Esophagitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EG-760Z endoscope by Fujifilm
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Eosinophilic Esophagitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard Imaging

    High Magnification Imaging

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    January 29, 2021
    Last Updated
    February 21, 2021
    Sponsor
    University of Zurich
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04769232
    Brief Title
    Endoscopic Characterisation of Inflammation in EoE
    Acronym
    ECI-EoE
    Official Title
    Endoscopic Characterisation of Inflammatory Activity in EoE: Comparison of Two Gastroscopes With High Magnification to the Goldstandard Histology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2021 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    November 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Zurich

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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).
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eosinophilic Esophagitis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Imaging
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    High Magnification Imaging
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    EG-760Z endoscope by Fujifilm
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    High magnification leeds to more accurate histologic sampling
    Description
    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.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Target biopsies are non-inferior to standard biopsies
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bernhard Morell
    Phone
    0041442551111
    Email
    bernhard.morell@usz.ch
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fritz Murray
    Phone
    0041442551111
    Email
    fritz.murray@usz.ch
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luc Biedermann
    Organizational Affiliation
    Universitätsspital Zürich
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26552779
    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.
    Results Reference
    background
    PubMed Identifier
    29065437
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22610003
    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.
    Results Reference
    background
    Links:
    URL
    https://www.iso.org/home.html
    Description
    Clinical investigation of medical devices for human subjects -- Good clinical practice

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