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Effects of Helicobacter pylori eradication on the development of metachronous gastric cancer after endoscopic treatment: Analysis of molecular alterations by a randomized controlled trial

Effects of Helicobacter pylori eradication on the development of metachronous gastric cancer after endoscopic treatment: Analysis of molecular alterations by a randomized controlled trial - H. pylori eradication and gastric cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006206
Enrollment
100
Registered
2011-08-21
Start date
2010-11-01
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 or adenoma

Interventions

H. pylori un-eradicated group H. pylori eradicated group

Sponsors

Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The indications for ESD for gastric neoplasms such as intramucosal gastric cancer and adenoma; (1) intramucosal papillary, well- or moderately-differentiated tubular adenocarcinoma of any size without ulceration, (2) intramucosal differentiated-type adenocarcinoma of less than 3 cm with an ulcer scar, (3) submucosal invasive cancer limited to 500 micrometer or less in invasion depth and differentiated-type adenocarcinoma of less than 3 cm without an ulcer scar and venous/lymphatic invasion

Exclusion criteria

Exclusion criteria: (1)Patients with malignancy in other organs (2)Patients with having allergy to drugs used for H. pylori eradication (3)Past episode of H. pylori treatment (4)Patients with regularly taking non-steroidal anti-inflammatory drugs (5)Patients with having a past history of esophagectomy or gastrectomy (6)Patients who have determined by the physicians to have any reasons of unqualified

Design outcomes

Primary

MeasureTime frame
Changes of biomarkers related to carcinogenesis are evaluated at baseline and 1-yr after intervention with/without H. pylori eradication Primary endpoint: Change of microsatellite instability

Secondary

MeasureTime frame
Secondary endpoint: Changes of promoter hypermethylation of some tumor-related genes

Countries

Japan

Contacts

Public ContactJiro Watari

Hyogo College of Medicine Division of Gastroenterology, Department of Internal Medicine

watarij@hyo-med.ac.jp0798-45-6662

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026