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Effect of Helicobacter Pylori Eradication on the New Tumor Development After Endoscopic Resection of Gastric Tumors

Phase 3
20 Years
75 Years
Not Enrolling
Gastric Tumor, Helicobacter Pylori, Endoscopic Resection, Metachronous Neoplasms

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Trial Information

Effect of Helicobacter Pylori Eradication on the New Tumor Development After Endoscopic Resection of Gastric Tumors

The association between Helicobacter pylori infection and development of gastric cancer has
been established by epidemiologic studies. Conversely, eradication of H. pylori showed no
significant reduction of the incidence of gastric cancer in a large-scale, double-blind,
randomized controlled trial. Eradication of H. pylori to prevent cancer was only effective
in the subgroup without precancerous lesions (i,e, dysplasia, intestinal metaplasia, and
atrophy). In contrast, randomized prospective study in Japan showed that H. pylori
eradication after endoscopic resection of early gastric cancer significantly reduced
metachronous gastric cancer. To solve this conflicting issue is critical because gastric
cancer is the second leading cancer incidence worldwide, particularly Korea, Japan, and
China have highest cancer incidence, and its incidence might decrease by H. pylori
eradication treatment.

With respect to therapeutic modality, endoscopic resection for early gastric cancer is
currently the established treatment of choice in Korea and Japan because it has been proven
to be both minimally invasive and effective in the curative treatment of early gastric

Endoscopic resection has also been performed in the gastric dysplasia because dysplasia has
to some extent malignant potential although firm evidence is lacking. In comparison with
surgical resection, endoscopic resection conserves remnant stomach. Accordingly, patients
treated with endoscopic resection have higher possibility for metachronous gastric cancer
than those treated with surgical resection.

So far, it has not yet been clearly established whether H pylori eradication for gastric
tumors (early gastric cancer and gastric dysplasia) could reduce metachronous cancer. We
performed randomized controlled, open-label trial on the effect of new cancer development
after H pylori eradication for gastric tumors.

Inclusion Criteria:

- H pylori infected patients with gastric low-grade dysplasia, high-grade dysplasia,
and early gastric cancer

- Gastric tumor is completely removed through endoscopic resection.

Exclusion Criteria:

- Patients underwent gastrectomy before enrollment

- patients underwent endoscopic resection before enrollment

- Previous history of eradication for H. pylori

- Pregnancy

- Aged <20 yr old or aged >75 yr old

- Patients underwent additional gastrectomy due to incomplete endoscopic resection

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of gastric tumor.

Outcome Description:

Primary outcome is the incidence of new cancer development after endoscopic resection of gastric tumors between eradication and control groups. Previous reports showed the incidence of new cancer between two groups differs at least 3years.

Outcome Time Frame:

we set the time frame as at least three years.

Safety Issue:


Principal Investigator

Sang Gyun Kim, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Internal Medicine and Liver Research Institute


Korea: Institutional Review Board

Study ID:




Start Date:

January 2005

Completion Date:

February 2011

Related Keywords:

  • Gastric Tumor
  • Helicobacter Pylori
  • Endoscopic Resection
  • Metachronous Neoplasms
  • gastric tumor
  • Helicobacter pylori
  • endoscopic resection
  • metachronous neoplasms
  • Neoplasms
  • Stomach Neoplasms
  • Neoplasms, Second Primary