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NCT Number: NCT07253948

Distribution Characteristics of Helicobacter Pylori

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location status: Recruiting

Location contact

Dong Yang, Master

CONTACT

[email protected]

Hong Xu, Professor

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

immunohistochemical testing

Diagnostic Test

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.

Primary outcomes

  1. The status of Helicobacter pylori(H. pylori)

    Time frame: 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 outcomes

  1. the percentage of H. pylori positive status of gastric antrum in early gastric cancer

    Time frame: one year after the endoscopic submucosal dissection (ESD)

    the percentage of H. pylori positive status of gastric antrum in early gastric cancer was assessed

Other outcomes

  1. the percentage of H. pylori positive status of gastric body in early gastric cancer

    Time frame: one year after the endoscopic submucosal dissection (ESD)

    the percentage of H. pylori positive status of gastric body in early gastric cancer was assessed

  2. the percentage of H. pylori positive status of gastric antrum in gastritis

    Time frame: one year after the endoscopic submucosal dissection (ESD)

    the percentage of H. pylori positive status of gastric antrum in gastritis was assessed

  3. the percentage of H. pylori positive status of gastric body in gastritis

    Time frame: one year after the endoscopic submucosal dissection (ESD)

    the percentage of H. pylori positive status of gastric body in gastritis was assessed

Study contacts

Contact information is provided by the study sponsor or research team.

Dong Yang, Doctor

CONTACT

[email protected]

86-18844097668

Hong Xu, Professor

CONTACT

[email protected]

0431-88782821

Sponsors and collaborators

Lead sponsor

Jilin University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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