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临床试验/NCT07253948
NCT07253948招募中不适用

Distribution Characteristics of Helicobacter Pylori in Different Gastritis and Early Gastric Cancer States Using Immunohistochemical Staining

Jilin University1 个研究点 分布在 1 个国家目标入组 231 人开始时间: 2025年10月22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
231
试验地点
1
主要终点
The status of Helicobacter pylori(H. pylori)

研究概览

简要总结

This study aimed to analyze the distribution characteristics of Helicobacter pylori(H. pylori) in varying stages of atrophic gastritis and early gastric cancer using immunohistochemical staining, with the goal of providing guidance for the early screening of gastric cancer.

A retrospective analysis was conducted on gastric biopsy cases that underwent H. pylori immunohistochemical staining at our center from March 1, 2023, to August 15, 2025. Cases were classified into non-atrophic and atrophic groups based on the presence or absence of gastric atrophy. All cases were further divided into non-open and open atrophy groups and additionally into early gastric cancer and non-cancer groups. The distribution of H. pylori across subgroups was compared, and multivariate analyses were performed to identify risk factors associated with the development of early gastric cancer.

详细描述

A retrospective analysis was performed on cases that underwent gastric H. pylori immunohistochemical staining at our center from March 1, 2023, to August 15, 2025.

Immunohistochemical results were reviewed independently by two experienced pathologists, with disagreements resolved by a third. After applying inclusion and exclusion criteria, cases were classified according to the Kimura-Takemoto classification : First, patients were categorized into non-atrophic and atrophic groups based on the presence of atrophy. Second, all cases were further divided into non-open and open atrophy groups. Open atrophy was defined as a degree of O1 or greater (endoscopic atrophic border extending beyond the cardia). All cases were additionally categorized into early gastric cancer and non-cancer groups depending on whether early gastric cancer lesions were present or had previously been identified. Early gastric cancer was defined based on endoscopic submucosal dissection (ESD) indications: (i) UL0 cT1a differentiated-type carcinomas; (ii) UL1 cT1a differentiated-type carcinomas with a long diameter ≤3 cm; or (iii) UL0 cT1a undifferentiated-type carcinomas with a long diameter ≤2 cm. Immunohistochemical staining was performed using an anti-H. pylori antibody (Beijing Zhongshan Golden Bridge Biotechnology Co., Ltd, Beijing, China). Positive results were graded as mild (1+): occasional bacteria or colonization in <1/3 of the specimen length; moderate (2+): colonization exceeding 1/3 but <2/3 of the specimen, or continuous but sparse distribution on the epithelial surface; and severe (3+): clusters of H. pylori distributed across the full length of the specimen. The gastric body and antrum were assessed separately, and distribution patterns were classified as gastric antrum > gastric body, gastric antrum = gastric body, or gastric body > gastric antrum. The distribution of H. pylori across subgroups was compared, and multivariate analyses were performed to identify risk factors associated with the development of early gastric cancer.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Retrospective

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
否

入选标准

  • •age 18-80 years
  • •received H. pylori immunohistochemical testing at our center and tested positive.

排除标准

  • •biopsies not collected from both the greater and lesser curvatures of the gastric antrum and body
  • •history of stomach surgery
  • •suspected autoimmune gastritis under endoscopy
  • •liver cirrhosis
  • •severe comorbidities such as advanced cancer or renal failure
  • •advanced gastric cancer or gastric lymphoma

结局指标

主要结局

The status of Helicobacter pylori(H. pylori)

时间窗: one week after the endoscopic submucosal dissection (ESD)

The status of H. pylori included negative and positive status. Positve results were graded as mild (1+): occasional bacteria or colonization in \<1/3 of the specimen length; moderate (2+): colonization exceeding 1/3 but \<2/3 of the specimen, or continuous but sparse distribution on the epithelial surface; and severe (3+): clusters of H. pylori distributed across the full length of the specimen. The gastric body and antrum were assessed separately.

次要结局

  • the percentage of H. pylori positive status of gastric antrum in early gastric cancer(one year after the endoscopic submucosal dissection (ESD))

研究者

发起方
Jilin University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong Yang

Principal Investigator

Jilin University

研究点 (1)

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