LCI in Chronic Atrophic Gastritis and Early Gastric Cancer

Recruiting

• Conditions: CAG - Chronic Atrophic Gastritis; EGC - Early Gastric Cancer
• Interventions: Other: Compare color information and mucosal microvascular density

• Registration Number: NCT06152263
• Lead Sponsor: Affiliated Hospital to Academy of Military Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-09-30
• Study First Submitted: 2023-10-29
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-11-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-14
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Atrophic or Cancerous	Compare color information and mucosal microvascular density	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.

Primary Outcome Measures

Name	Time	Method
Microvascular density differences between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa	up to 2 weeks	Histological microvascular density of atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be evaluated by using CD31 immunostaining. It is speculated that there is a significant difference in the mucosal microvascular density between atrophic and non-atrophic mucosa and between cancerous and non-cancerous mucosa.
Color differences between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa	up to 4 weeks	The color values of atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa, will be quantified by using the International Commission on Illumination 1976 (L∗, a∗, b∗) color space. It is speculated that there is a significant difference in the color difference between atrophic and non-atrophic mucosa and between cancerous and non-cancerous mucosa.

Trial Locations

Locations (1)

The Fifth Medical Center of Chinese PLA General Hosptial; 🇨🇳 Beijing, Beijing, China