Distribution Characteristics of Helicobacter Pylori

Jilin University

Status: Enrolling

Conditions: Early Gastric Cancer; Helicobacter Pylori

Treatments: Diagnostic Test: immunohistochemical testing

Study type: Observational

Funder types: Other

Identifiers

NCT07253948

130029

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 231 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

231 participants in 1 patient group

received H. pylori immunohistochemical testing at our center and tested positive

Treatment:

Diagnostic Test: immunohistochemical testing