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

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

Inclusion Criteria2

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

Exclusion Criteria6

  • 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

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.


Locations(1)

the First Hospital of Jilin University

Changchun, Jilin, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07253948


Related Trials