Distribution Characteristics of Helicobacter Pylori
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorJilin University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
age 18-80 years
received H. pylori immunohistochemical testing at our center and tested positive.
Disqualifiers
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
Trial population
Cases that underwent gastric H. pylori immunohistochemical staining at our center from March 1, 2023, to August 15, 2025.
Trial design
Design model
Ecologic or community
Time perspective
Retrospective
Treatments tested in this trial
immunohistochemical testing
Diagnostic testImmunohistochemical 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.
Treatment groups
231 Participants
are divided into 1 treatment groupGroup A: received H. pylori immunohistochemical testing at our center and tested positive1 intervention
Trial outcomes
Primary outcomes
1
The status of Helicobacter pylori(H. pylori)
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.
Time frame
one week after the endoscopic submucosal dissection (ESD)Secondary outcomes
1
the percentage of H. pylori positive status of gastric antrum in early gastric cancer
the percentage of H. pylori positive status of gastric antrum in early gastric cancer was assessed
Time frame
one year after the endoscopic submucosal dissection (ESD)Other outcomes
1
the percentage of H. pylori positive status of gastric body in early gastric cancer
the percentage of H. pylori positive status of gastric body in early gastric cancer was assessed
Time frame
one year after the endoscopic submucosal dissection (ESD)2
the percentage of H. pylori positive status of gastric antrum in gastritis
the percentage of H. pylori positive status of gastric antrum in gastritis was assessed
Time frame
one year after the endoscopic submucosal dissection (ESD)3
the percentage of H. pylori positive status of gastric body in gastritis
the percentage of H. pylori positive status of gastric body in gastritis was assessed
Time frame
one year after the endoscopic submucosal dissection (ESD)Sponsors and contacts
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Source ClinicalTrials.gov