RecruitingNCT07253948

Distribution Characteristics of Helicobacter Pylori

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

Sponsor

Jilin University

Enrollment

231 participants

Start Date

Oct 22, 2025

Study Type

OBSERVATIONAL

Conditions

Early Gastric Cancer Helicobacter Pylori

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This observational study maps where H. pylori bacteria are found in different parts of the stomach in patients who have already tested positive for this infection. H. pylori is a common bacterium that can cause stomach ulcers and increase the risk of stomach cancer. Understanding its distribution may help improve detection and treatment strategies. **You may be eligible if...** - You are between 18 and 80 years old - You have already tested positive for H. pylori by immunohistochemistry (a laboratory test on tissue) at the study center - Biopsies were taken from multiple areas of your stomach (both the greater and lesser curvature of the antrum and body) **You may NOT be eligible if...** - Tissue samples were not collected from both the greater and lesser curvature areas - You have a history of stomach surgery - You have autoimmune gastritis - You have liver cirrhosis - You have severe conditions such as advanced cancer or kidney failure - You have advanced stomach cancer or stomach lymphoma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTimmunohistochemical testing

Immunohistochemical results were reviewed independently by two experienced pathologists, with disagreements resolved by a third. 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.