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临床试验/NCT06152263
NCT06152263招募中不适用

Color Information From Linked Color Imaging is Associated With Mucosal Microvascular Density in Chronic Atrophic Gastritis and Early Gastric Cancer

Affiliated Hospital to Academy of Military Medical Sciences1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10
试验地点
1
主要终点
Microvascular density differences between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Microvascular density differences between the atrophic and non-atrophic mucosa, as well as cancerous and non-cancerous mucosa

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Affiliated Hospital to Academy of Military Medical Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

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