LCI in Chronic Atrophic Gastritis and Early Gastric Cancer

Trial Title: LCI in Chronic Atrophic Gastritis and Early Gastric Cancer

NCT ID: NCT06152263

Condition: CAG - Chronic Atrophic Gastritis
EGC - Early Gastric Cancer

Conditions: Official terms:
Stomach Neoplasms
Gastritis
Gastritis, Atrophic
Atrophy

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

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Compare color information and mucosal microvascular density
Description: To investigate the association between the color and mucosal microvascular density of CAG and EGC using linked color imaging.
Arm group label: Atrophic or Cancerous

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.

Criteria for eligibility:

Study pop:
Patients diagnosed with CAG or EGC by esophagogastroduodenoscopy

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: The Fifth Medical Center of Chinese PLA General Hosptial

Address:
City: Beijing
Zip: 100039
Country: China

Status: Recruiting

Contact:
Last name: Yan Liu, MD

Phone: +8613911798288
Email: 13911798288@163.com

Start date: September 30, 2023

Completion date: December 30, 2023

Lead sponsor:
Agency: Affiliated Hospital to Academy of Military Medical Sciences
Agency class: Other

Source: Affiliated Hospital to Academy of Military Medical Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06152263