Multispectral Imaging Endoscopy in Digestive Inflammation (ENDOSPECTRALE)
Primary Purpose
Digestive Inflammation
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Record during endoscopy of video-endoscopy sequences and reflectance
Sponsored by
About this trial
This is an interventional diagnostic trial for Digestive Inflammation focused on measuring digestive inflammation, multispectral imaging, multispectral gastroscopy, multispectral coloscopy
Eligibility Criteria
Inclusion Criteria:
- Patients needing a digestive endoscopy under general anesthesia, or a rectoscopy without anesthesia, with indicators of systematic biopsy regardless of reason;
- Aged ≥ 18 years;
- Covered by a public health insurance regime;
- Signed consent.
Exclusion Criteria:
- History of gastric or rectal surgery regardless of nature;
- Gastrointestinal bleeding by hematemesis or rectal bleeding;
- Hemostasis disorders preventing biopsy.
- Difficulties in understanding french language;
- Pregnant or breast feeding woman;
- Woman of childbearing age without reliable contraception;
- Adult under legal protection with tutor or curator.
Sites / Locations
- Service Hépato-Gastroentérologie, Hôpital Ambroise Paré
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
video recording of endoscopy
Arm Description
Record of sequences of video-endoscopy and the reflectance of light through fibroscopy
Outcomes
Primary Outcome Measures
Reflectance endoscopy for gastric mucosa with lesions
The reflectance endoscopy for gastric and rectal mucosa in different wavelength of presence of the lesions, in comparison with anatomopathological analysis on gastric and rectal mucosa, to diagnosis acute and chronic inflammation, glandular atrophy and intestinal metaplasia.
This outcome will show reflectance for mucosa in presence of lesions which classified by anatomopathological analysis: comparison report.
Secondary Outcome Measures
Statistic association between profiles of reflectance and anatomopathological classifications
Statistic association between the profiles of reflectance in different frequencies and anatomopathological classifications in stomach and rectal analysis (such as acute or chronic inflammation, glandular atrophy and intestinal metaplasia).
Correlation between reflectance and intensity of inflammation
Correlation between reflectance to different frequencies and intensity of inflammation in stomach (according to the Classification of Sydney) and in rectum (according to Erben et al).
Sub-study: morphological comparison between 2D/3D reconstruction and endoscopist's description
Morphological comparison between reconstruction in 2D or 3D and morphological description of mucosa (the antra and the cardia) by endoscopist.
The type of method as structure from motion (SFM) should be used to map in 3D or 2D the antra, few publication show method of mapping in 3D or 2D for hollow organs, potentially transformable and utilisable under clinical condition.
Full Information
NCT ID
NCT04287569
First Posted
December 16, 2019
Last Updated
August 25, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04287569
Brief Title
Multispectral Imaging Endoscopy in Digestive Inflammation
Acronym
ENDOSPECTRALE
Official Title
Use of Multispectral Imaging in Digestive Inflammation Diagnosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 2, 2020 (Actual)
Primary Completion Date
December 22, 2021 (Actual)
Study Completion Date
December 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims as principal objective to show the association between reflectance intensity of mucosa at different wave lengths and
the presence of acute or chronic inflammation in stomach or rectum and normal mucosa;
the presence of glandular atrophy in stomach or intestinal metaplasia.
The secondary objectives are:
to identify reflectance profile which characterize an acute or a chronic inflammation, a glandular atrophy or an intestinal metaplasia, respectively;
to find a correlation between the reflectance to different frequencies and intensity of inflammation according to Sydney Classification in stomach (Dixon M F 1994) and in rectum (Erben U 2014).
Detailed Description
This is a comparative, prospective, non randomized, controled, mono-centric study.
Eligible patients: patients planned to undergo an upper gastrointestinal endoscopy or a rectosigmoidoscopy with biopsy in the digestive endoscopy unit of Hôpital Ambroise Paré. For patients accept participating to the study and sign the informed consent, they will be enrolled in the study and the recorded imaging of stomach or rectum will be obtained.
Patient management will not be modified in this study as compared to usual endoscopy procedure. Multispectral endoscopy will only prolong the examination 1 minute in order to obtain the imaging. The study consists of video records of endoscopy with white light and the reflected light projected by the fibre introduced 60 seconds in examined channel. This reflected light will be redirected to a multispectral camera.
The endoscopy examinations will be performed in gastric antrum and cardia when theses sites present abnormal position or contour. The biopsies samples of gastric mucosa will be performed in the antrum or the cardia according to the Guideline of the Société Française d'Endoscopie Digestive.
6 groups of patients will be constituted (included 2 groups of control) as described below and compared posteriorly:
The control group of rectum: 20 patients with negative result of endoscopy examination (-) and negative result of anatomopathological analysis (-);
The group of 20 patients with positive result of endoscopy examination (+) and positive result of anatomopathological analysis (+) in rectum;
The group of 20 patients with negative result of endoscopy examination (-) and positive result of anatomopathological analysis (+) in rectum;
The control group of stomach: 60 patients with negative result of endoscopy examination (-) and negative result in anatomopathological analysis (-);
The group of 45 patients with positive result of endoscopy examination (+) and positive result of anatomopathological analysis (+) in stomach;
The group of 30 patients with negative result of endoscopy examination (-) and positive result of anatomopathological analysis (+) in stomach.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive Inflammation
Keywords
digestive inflammation, multispectral imaging, multispectral gastroscopy, multispectral coloscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
video recording of endoscopy
Arm Type
Experimental
Arm Description
Record of sequences of video-endoscopy and the reflectance of light through fibroscopy
Intervention Type
Device
Intervention Name(s)
Record during endoscopy of video-endoscopy sequences and reflectance
Intervention Description
Record of video-endoscopy sequences and reflectance, during endoscopy with biopsy.
Primary Outcome Measure Information:
Title
Reflectance endoscopy for gastric mucosa with lesions
Description
The reflectance endoscopy for gastric and rectal mucosa in different wavelength of presence of the lesions, in comparison with anatomopathological analysis on gastric and rectal mucosa, to diagnosis acute and chronic inflammation, glandular atrophy and intestinal metaplasia.
This outcome will show reflectance for mucosa in presence of lesions which classified by anatomopathological analysis: comparison report.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Statistic association between profiles of reflectance and anatomopathological classifications
Description
Statistic association between the profiles of reflectance in different frequencies and anatomopathological classifications in stomach and rectal analysis (such as acute or chronic inflammation, glandular atrophy and intestinal metaplasia).
Time Frame
Up to 12 months
Title
Correlation between reflectance and intensity of inflammation
Description
Correlation between reflectance to different frequencies and intensity of inflammation in stomach (according to the Classification of Sydney) and in rectum (according to Erben et al).
Time Frame
Up to 12 months
Title
Sub-study: morphological comparison between 2D/3D reconstruction and endoscopist's description
Description
Morphological comparison between reconstruction in 2D or 3D and morphological description of mucosa (the antra and the cardia) by endoscopist.
The type of method as structure from motion (SFM) should be used to map in 3D or 2D the antra, few publication show method of mapping in 3D or 2D for hollow organs, potentially transformable and utilisable under clinical condition.
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients needing a digestive endoscopy under general anesthesia, or a rectoscopy without anesthesia, with indicators of systematic biopsy regardless of reason;
Aged ≥ 18 years;
Covered by a public health insurance regime;
Signed consent.
Exclusion Criteria:
History of gastric or rectal surgery regardless of nature;
Gastrointestinal bleeding by hematemesis or rectal bleeding;
Hemostasis disorders preventing biopsy.
Difficulties in understanding french language;
Pregnant or breast feeding woman;
Woman of childbearing age without reliable contraception;
Adult under legal protection with tutor or curator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Lamarque, MD, PhD
Organizational Affiliation
Service Hépato-Gastroentérologie, Hôpital Ambroise Paré, Boulogne Billancourt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service Hépato-Gastroentérologie, Hôpital Ambroise Paré
City
Boulogne-Billancourt
State/Province
Île-de-France
ZIP/Postal Code
92100
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multispectral Imaging Endoscopy in Digestive Inflammation
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