Effects of H. Pylori Eradication on the Gastric Preneoplastic Lesion and Neoplasm After ESD

National Cancer Center (NCC)

Status and phase: Active, not recruiting; Phase 3

Conditions: Early Gastric Cancer; Helicobacter Pylori Infection; Endoscopic Resection

Treatments: Drug: 7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin; Drug: Placebo, Omeprazole or Rabeprazole, Clarithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02407119

NCCCTS03-062

1310280 (Other Grant/Funding Number)

Details and patient eligibility

About

This study evaluates whether Helicobacter pylori eradication improves precancerous lesions including glandular atrophy and intestinal metaplasia as well as metachronous cancers or dysplasias after endoscopic mucosal resection for gastric cancer.

Full description

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 and prevents metachronous gastric cancer is controversial. And the issue has not been evaluated in gastric cancer patients. However, despite the conflicting evidences from two open labelled randomized controlled trials, current guidelines from various regions 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 can eventually reduce secondary gastric cancer development and provide evidence for current guidelines.

Enrollment: 470 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Early Gastric cancer or high grade dysplasia confirmed by endoscopy

  • Histologically confirmed well or moderately differentiated adenocarcinoma, or high grade dysplasia
  • Submucosal invasion is not suspected
  • No evidence of ulceration or ulcer scar within the lesion

• Helicobacter pylori infection was confirmed by histological evaluation and rapid urease test

• Pre op CT stage: IA (T1N0M0) according to UICC TNM classification system

• Informed consent should be signed

Exclusion criteria

• Recurrent gastric cancer
• Previous serious side effect to antibiotics
• H. pylori eradication treatment history
• Poorly differentiated adenocarcinoma or Signet ring cell carcinoma
• Undergoing operation due to complication of EMR
• Undergoing operation due to remnant cancer
• Other malignancy within the past 5 years
• Pregnant or nursing women
• Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases
• Psychiatric disorder that would preclude compliance

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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470 participants in 2 patient groups, including a placebo group

7 day H.pylori eradication

Active Comparator group

Description:

Treatment: Omeprazole 20 mg or Rabeprazole 10 mg bid + clarithromycin 500 mg and amoxicillin 1,000 mg bid for 7 days

Treatment:

Drug: 7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin

Placebo

Placebo Comparator group

Description:

Omeprazole 20 mg or Rabeprazole 10 mg bid + Placebo for two antibiotics (clarithromycin and amoxicillin) bid for 7 days

Treatment:

Drug: Placebo, Omeprazole or Rabeprazole, Clarithromycin