NCT04769232

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

6 months

First QC Date

January 29, 2021

Last Update Submit

February 21, 2021

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Target biopsies are non-inferior to standard biopsies

    6 months

Study Arms (2)

Standard Imaging

ACTIVE COMPARATOR

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.

Device: EG-760Z endoscope by Fujifilm

High Magnification Imaging

EXPERIMENTAL

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.

Device: EG-760Z endoscope by Fujifilm

Interventions

EG-760Z endoscope by FujifilmDEVICE

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.

High Magnification ImagingStandard Imaging

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 26552779BACKGROUND

  • 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.

    PMID: 29065437BACKGROUND

  • 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.

    PMID: 22610003BACKGROUND

Related Links

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Luc Biedermann

    Universitätsspital Zürich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernhard Morell

CONTACT

0041442551111bernhard.morell@usz.ch

Fritz Murray

CONTACT

0041442551111fritz.murray@usz.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 24, 2021

Study Start

March 1, 2021

Primary Completion

September 1, 2021

Study Completion

November 1, 2021

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share