Comparison of endoscopic diagnostic performance between early gastric cancer detected after Helicobacter pylori eradication and early gastric cancer currently infected with Helicobacter pylori, a pilot study.

Comparison of endoscopic diagnostic performance between early gastric cancer detected after Helicobacter pylori eradication and early gastric cancer currently infected with Helicobacter pylori, a pilot study. - Gastric cancer after Helicobacter pylori eradication study.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000047709

Enrollment

200

Registered

2022-05-10

Start date

2022-05-10

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Early gastric cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with early-stage gastric cancer who are scheduled to undergo endoscopic or surgical resection with a diagnosis of Vienna Classification Category 4 or 5 on biopsy histopathology of the lesion. 2. Patients with ECOG-performance status 0 or 1. 3. Patients must be at least 20 years of age at the time of consent. 4. Patients who have given written consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients with postoperative stomach or gastrointestinal tract. 2. Patients who are determined to be Helicobacter pylori uninfected. 3. Patients who are judged by the physician to have a serious underlying disease such as cerebral infarction or severe heart failure. 4. Patients who are judged by the investigator or subinvestigator to be inappropriate to conduct this study. 5. Patients with gastric cancer detected by endoscopy less than 6 months after Helicobacter pylori eradication.

Design outcomes

Primary

Measure	Time frame
To compare the qualitative diagnostic performance of M-NBI observation using the vessel plus surface classification system for early gastric cancer detected after H. pylori eradication and early gastric cancer currently infected with H. pylori.	—

Secondary

Measure	Time frame
1. To compare the qualitative diagnostic performance of conventional white-light observation including dye endoscopic observation using color plus surface classification system for gastric cancer after H. pylori eradication and gastric cancer currently infected with H. pylori. 2. To compare the diagnostic performance of M-NBI and C-WLI+CE for the horizontal extent of early gastric cancer by M-NBI and C-WLI+CE for gastric cancer after H. pylori eradication and gastric cancer currently infected with H. pylori. 3. To compare the diagnostic performance of M-NBI and C-WLI+CE for the diagnosis of gastric carcinoma after H. pylori eradication and gastric carcinoma infected with H. pylori by histopathological classification into low atypia and other lesions. 4. To compare the range diagnostic performance of M-NBI and C-WLI+CE for gastric cancer after H. pylori eradication and gastric cancer currently infected with H. pylori according to the presence or absence and extent of noncancerous epithelial covering on the surface of intramucosal carcinoma nests.	—

Measure

Time frame

1. To compare the qualitative diagnostic performance of conventional white-light observation including dye endoscopic observation using color plus surface classification system for gastric cancer after H. pylori eradication and gastric cancer currently infected with H. pylori. 2. To compare the diagnostic performance of M-NBI and C-WLI+CE for the horizontal extent of early gastric cancer by M-NBI and C-WLI+CE for gastric cancer after H. pylori eradication and gastric cancer currently infected with H. pylori. 3. To compare the diagnostic performance of M-NBI and C-WLI+CE for the diagnosis of gastric carcinoma after H. pylori eradication and gastric carcinoma infected with H. pylori by histopathological classification into low atypia and other lesions. 4. To compare the range diagnostic performance of M-NBI and C-WLI+CE for gastric cancer after H. pylori eradication and gastric cancer currently infected with H. pylori according to the presence or absence and extent of noncancerous epithelial covering on the surface of intramucosal carcinoma nests.

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Countries

Japan

Contacts

Public ContactTakayuki Hirase

Fukuoka University Chikushi Hospital Gastroenterology

d.r.g.b0116@gmail.com+81929211011

Outcome results