Multispectral Imaging Endoscopy in Digestive Inflammation

Digestive Inflammation Clinical Trial

— ENDOSPECTRALE  

Official title:

Use of Multispectral Imaging in Digestive Inflammation Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04287569
• Other study ID #: P160409J
• Secondary ID: 2019-A01602-55
• Status: Completed
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: December 22, 2021

Study information

• Verified date: April 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 22, 2021
• Est. primary completion date: December 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Digestive Inflammation
• Inflammation

Intervention

Device:
• Record during endoscopy of video-endoscopy sequences and reflectance
Record of video-endoscopy sequences and reflectance, during endoscopy with biopsy.

Locations

Country	Name	City	State
France	Service Hépato-Gastroentérologie, Hôpital Ambroise Paré	Boulogne-Billancourt	Île-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 12 months
Secondary	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).	Up to 12 months
Secondary	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).	Up to 12 months
Secondary	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.	Up to 12 months