Efficacy Study of Helicobacter Pylori Eradication in Patients Undergoing Subtotal Gastrectomy for Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Helicobacter pylori (H. pylori) is associated with gastric cancer in epidemiological
      studies.Gastric atrophy and intestinal metaplasia caused by H. pylori are considered as
      precancerous lesions, but whether H. pylori eradication improves these lesions is
      controversial.The primary objective of this study is to evaluate whether Helicobacter pylori
      eradication improves glandular atrophy and intestinal metaplasia which are known to be
      precancerous condition in patients undergoing subtotal gastrectomy for gastric cancer.
    

Detailed description: 
      Helicobacter pylori (H. pylori) is a primary etiological agent leading to chronic gastritis
      and peptic ulcer. The organism is also associated with gastric cancer in epidemiological
      studies. However, detailed mechanism of carcinogenesis remains unknown. Histolopathological
      studies indicate that chronic H. pylori infection progresses over decades through stages of
      chronic gastritis, atrophy, intestinal metaplasia, dysplasia and cancer. Gastric atrophy and
      intestinal metaplasia are considered as precancerous lesions, but whether H. pylori
      eradication improves these lesions is controversial. And the issue has not been evaluated in
      gastric cancer patients. However, despite the lack of evidence proven by a well-designed
      study, current guidelines from Europe and Japan recommend H. pylori eradication treatment in
      patients who were treated for gastric cancer by surgically or endoscopically. Thus, it is
      important to evaluate whether H. pylori eradication can improve known precancerous lesion,
      i.e. glandular atrophy and intestinal metaplasia in gastric cancer patients. Such
      histological improvement may eventually reduce secondary gastric cancer development and
      provide evidence for current guidelines. Helicobacter pylori is a primary etiological agent
      leading to chronic gastritis and peptic ulcer. The organism is also associated with gastric
      cancer in epidemiological studies. However, detailed mechanism of carcinogenesis remains
      unknown. Histolopathological studies indicate that chronic H. pylori infection progresses
      over decades through stages of chronic gastritis, atrophy, intestinal metaplasia, dysplasia
      and cancer. Gastric atrophy and intestinal metaplasia are considered as precancerous lesions,
      but whether H. pylori eradication improves these lesions is controversial. And the issue has
      not been evaluated in gastric cancer patients. However, despite the lack of evidence proven
      by a well-designed study, current guidelines from Europe and Japan recommend H. pylori
      eradication treatment in patients who were treated for gastric cancer by surgically or
      endoscopically. Thus, it is important to evaluate whether H. pylori eradication can improve
      known precancerous lesion, i.e. glandular atrophy and intestinal metaplasia in gastric cancer
      patients. Such histological improvement may eventually reduce secondary gastric cancer
      development and provide evidence for current guidelines.
    

Intervention name(s): Helicobacter pylori eradication; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Omeprazole 20 mg or Rabeprazole 10 mg bid + clarithromycin 500 mg and amoxicillin 1,000 mg bid for 7 days; Omeprazole 20 mg or Rabeprazole 10 mg bid + two placebo (for antibiotics) for 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Helicobacter pylori; glandular atrophy; intestinal metaplasia; subtotal gastrectomy; gastric cancer; Precancerous lesion of gastric cancer