Clinical trial NCT06152263: LCI in Chronic Atrophic Gastritis and Early Gastric Cancer
Official title: Color Information From Linked Color Imaging is Associated With Mucosal Microvascular Density in Chronic Atrophic Gastritis and Early Gastric Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: CAG - Chronic Atrophic Gastritis
EGC - Early Gastric Cancer
Keywords: color information
linked color imaging
mucosal microvascular density
chronic atrophic gastritis
early gastric cancer
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with CAG or EGC by esophagogastroduodenoscopy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Color differences between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa
timeFrame: up to 4 weeks
measure: Microvascular density differences between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa
timeFrame: up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of Chinese PLA General Hosptial
state: Beijing
Study officials:
affiliation: The Fifth Medical Center of Chinese PLA General Hosptial
name: Yan Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: