Service Hépato-Gastroentérologie, Hôpital Ambroise Paré
Boulogne-Billancourt, Île-de-France Region, 92100, France
NCT Number: NCT04287569
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Boulogne-Billancourt, Île-de-France Region, 92100, France
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Record of video-endoscopy sequences and reflectance, during endoscopy with biopsy.
Time frame: Up to 12 months
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
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
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
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.
Assistance Publique - Hôpitaux de Paris
Other
Use of Multispectral Imaging in Digestive Inflammation Diagnosis
Acronym: ENDOSPECTRALE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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