Distribution Characteristics of Helicobacter Pylori

November 26, 2025 updated by: Dong Yang, Jilin University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

231

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cases that underwent gastric H. pylori immunohistochemical staining at our center from March 1, 2023, to August 15, 2025.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
received H. pylori immunohistochemical testing at our center and tested positive
Diagnostic test: immunohistochemical 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one week after the endoscopic submucosal dissection (ESD)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year after the endoscopic submucosal dissection (ESD)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
one year after the endoscopic submucosal dissection (ESD)
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
one year after the endoscopic submucosal dissection (ESD)
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
one year after the endoscopic submucosal dissection (ESD)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 13, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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