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Distribution Characteristics of Helicobacter Pylori

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07253948
Enrollment
231
Registered
2025-11-28
Start date
2025-10-22
Completion date
2025-12-31
Last updated
2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Gastric Cancer, Helicobacter Pylori

Keywords

Helicobacter pylori, Immunohistochemical staining, Atrophic gastritis, Early gastric cancer screening

Brief 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.

Detailed 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.

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.

Sponsors

Jilin University
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The status of Helicobacter pylori(H. pylori)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.

Secondary

MeasureTime frameDescription
the percentage of H. pylori positive status of gastric antrum in early gastric cancerone year after the endoscopic submucosal dissection (ESD)the percentage of H. pylori positive status of gastric antrum in early gastric cancer was assessed

Other

MeasureTime frameDescription
the percentage of H. pylori positive status of gastric body in early gastric cancerone year after the endoscopic submucosal dissection (ESD)the percentage of H. pylori positive status of gastric body in early gastric cancer was assessed
the percentage of H. pylori positive status of gastric antrum in gastritisone year after the endoscopic submucosal dissection (ESD)the percentage of H. pylori positive status of gastric antrum in gastritis was assessed
the percentage of H. pylori positive status of gastric body in gastritisone year after the endoscopic submucosal dissection (ESD)the percentage of H. pylori positive status of gastric body in gastritis was assessed

Countries

China

Contacts

Primary ContactDong Yang, Doctor
714488468@qq.com86-18844097668
Backup ContactHong Xu, Professor
x_hong@jlu.edu.cn0431-88782821

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026