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| ID | Type | Description | Link |
|---|---|---|---|
| 1310280 | Other Grant/Funding Number | National Cancer Center, Korea |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7 day H.pylori eradication | Active Comparator | Treatment: Omeprazole 20 mg or Rabeprazole 10 mg bid + clarithromycin 500 mg and amoxicillin 1,000 mg bid for 7 days |
|
| Placebo | Placebo Comparator | Omeprazole 20 mg or Rabeprazole 10 mg bid + Placebo for two antibiotics (clarithromycin and amoxicillin) bid for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement (histological) of glandular atrophy | Improvement of glandular atrophy at the corpus lesser curvature | 3 years after enrollment |
| Incidence of metachronous gastric cancer | Comparison of metachronous gastric cancer according to the allocated treatment | 3 years after last patient enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of new gastric dysplasia | Comparison of new gastric dysplasia according to the allocated treatment | 3 years after last patient enrollment |
| Overall survival | Comparison of overall survival according to the allocated treatment |
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Inclusion Criteria:
Early Gastric cancer or high grade dysplasia confirmed by endoscopy
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:
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| Name | Affiliation | Role |
|---|---|---|
| Il Ju Choi, MD, PhD | National Cancer Center, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center, Korea | Goyang-si | Gyeonggi-do | 410-769 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29562147 | Derived | Choi IJ, Kook MC, Kim YI, Cho SJ, Lee JY, Kim CG, Park B, Nam BH. Helicobacter pylori Therapy for the Prevention of Metachronous Gastric Cancer. N Engl J Med. 2018 Mar 22;378(12):1085-1095. doi: 10.1056/NEJMoa1708423. |
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|
| Placebo, Omeprazole or Rabeprazole, Clarithromycin | Drug | 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. |
|
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| 3 years after last patient enrollment |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D001284 | Atrophy |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| D017291 | Clarithromycin |
| D000658 | Amoxicillin |
| D054328 | Proton Pump Inhibitors |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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