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LCI in Chronic Atrophic Gastritis and Early Gastric Cancer

NCT ID: NCT06152263

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-30

Study Completion Date

2023-12-30

Brief Summary

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Color change is a useful marker for the endoscopic identification of chronic atrophic gastritis (CAG) and gastric cancer (GC). Several histopathological studies have suggested a correlation between certain gastrointestinal lesions and intramucosal vascularity. The aim of this study is to investigate the association between the color and mucosal microvascular density of CAG and early GC using linked color imaging (LCI). In this study, Lesions diagnosed as CAG and early GC will be observed using LCI. In each image, the color values of atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be quantified using the International Commission on Illumination 1976 (L∗, a∗, b∗) color space. Histological microvascular density in biopsy or resected specimens will be evaluated using CD31 immunostaining. Color differences at the atrophic border and cancerous border, defined as Euclidean distances of color values between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be calculated according to mucosal microvascular density.

Detailed Description

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In this study, 10 patients diagnosed with CAG or early GC by esophagogastroduodenoscopy at Fifth Medical Center of Chinese PLA General Hospital between September 2023 and December 2023 will be enrolled. The following equipment will be used for the study: LCI endoscope (EG-760Z, FUJIFILM Co., Tokyo, Japan), light sources (LASEREO LL-4450; Fujifilm Co.), and video processors (AdvanciaHD VP-4450HD; FUJIFILM Co.). During esophagogastroduodenography, the atrophic or cancerous border will be identified. Following identical compositions, images will be continuously captured via LCI. Endoscopic biopsy or resection will be performed, and the mucosal microvascular density will be histopathologically analyzed using the specimens. The color values of atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be quantified using the International Commission on Illumination 1976 (L∗, a∗, b∗) color space. Histological microvascular density in biopsy or resected specimens will be evaluated using CD31 immunostaining. Color differences at the atrophic border and cancerous border, defined as Euclidean distances of color values between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be calculated according to mucosal microvascular density.

Conditions

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CAG - Chronic Atrophic Gastritis EGC - Early Gastric Cancer

Keywords

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color information linked color imaging mucosal microvascular density chronic atrophic gastritis early gastric cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Atrophic or Cancerous

In each image, the color values of atrophic or cancerous will be quantified using the International Commission on Illumination 1976 (L∗, a∗, b∗) color space. Histological microvascular density in biopsy or resected specimens will be evaluated using CD31 immunostaining. Color differences at the atrophic border and cancerous border, defined as Euclidean distances of color values between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be calculated according to mucosal microvascular density.

Compare color information and mucosal microvascular density

Intervention Type OTHER

To investigate the association between the color and mucosal microvascular density of CAG and EGC using linked color imaging.

Non-atrophic or Non-cancerous

In each image, the color values of non-atrophic or non-cancerous will be quantified using the International Commission on Illumination 1976 (L∗, a∗, b∗) color space. Histological microvascular density in biopsy or resected specimens will be evaluated using CD31 immunostaining. Color differences at the atrophic border and cancerous border, defined as Euclidean distances of color values between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be calculated according to mucosal microvascular density.

No interventions assigned to this group

Interventions

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Compare color information and mucosal microvascular density

To investigate the association between the color and mucosal microvascular density of CAG and EGC using linked color imaging.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with chronic atrophic gastritis (CAG) and early gastric cancer (EGC). by esophagogastroduodenoscopy

Exclusion Criteria

* Inappropriate LCI images as a result of bleeding, ulceration, or excessive mucosal congestion
* Patients with severe anemia or portal hypertension
* Patients diagnosed as having a mixture of the differentiated and undifferentiated types of gastric carcinoma, or having helicobacter pylori infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Liu, MD

Role: PRINCIPAL_INVESTIGATOR

The Fifth Medical Center of Chinese PLA General Hosptial

Locations

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The Fifth Medical Center of Chinese PLA General Hosptial

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liang Wu, MD

Role: CONTACT

Phone: +8613911058553

Email: [email protected]

Facility Contacts

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Yan Liu, MD

Role: primary

Other Identifiers

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LCI in CAG and EGC

Identifier Type: -

Identifier Source: org_study_id