Early Gastric Cancer, Endoscopic Resection, Helicobacter Pylori Infection
Conditions
Keywords
H. pylori eradication, Atrophy, Intestinal metaplasia, Endoscopic resection, Stomach neoplasm
Brief summary
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.
Detailed 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.
Interventions
DRUG7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin
Omeprazole 20 mg or Rabeprazole 10 mg bid for 7 days, Clarithromycin 500 mg bid for 7 days, Amoxicillin 1,000 mg bid for 7 days.
DRUGPlacebo, Omeprazole or Rabeprazole, Clarithromycin
Omeprazole 20 mg or Rabeprazole 10 mg bid for 7 days, Placebo for clarithromycin 500 mg bid for 7 days, Placebo for amoxicillin 1,000 mg bid for 7 days.
Sponsors
National Cancer Center, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement (histological) of glandular atrophy | 3 years after enrollment | Improvement of glandular atrophy at the corpus lesser curvature |
| Incidence of metachronous gastric cancer | 3 years after last patient enrollment | Comparison of metachronous gastric cancer according to the allocated treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of new gastric dysplasia | 3 years after last patient enrollment | Comparison of new gastric dysplasia according to the allocated treatment |
| Overall survival | 3 years after last patient enrollment | Comparison of overall survival according to the allocated treatment |
Countries
South Korea
Outcome results
None listed