The aim of this study is to define the role of H. pylori eradication in the prevention of gastric cancer and its precursors in the context of a population-based endoscopic screening program.
Despite the decreasing incidence observed in the US and West European countries, gastric cancer is still an important global public health problem, especially in East Asian countries, where the burden of the disease is substantial. In the Republic of Korea, gastric cancer remains the leading cause of cancer in men and the fourth most common cancer in women. There is sufficient epidemiological and experimental evidence supporting a causal link between bacterial infection with H. pylori and gastric cancer development. However, evidence from clinical trials on the efficacy of H. pylori eradication with antimicrobial therapy to reduce the risk of gastric cancer is still limited. In addition, the beneficial or deleterious health impact of mass eradication at the population level has not been defined. In Korea, the prevalence of H. pylori infection in adults is still relatively high (\~60%, \>16 years old), and despite important reductions in mortality attributed to the screening program, incidence of gastric cancer remains elevated. The investigators propose to conduct a randomized controlled clinical trial in Korea to evaluate the efficacy of H. pylori eradication to prevent gastric cancer incidence in different population subgroups including age and baseline gastric pathology. This study will be conducted in the context of the National Cancer Screening Program and the Korean Central Cancer Registry. The proposed study will be a collaborative investigation between the National Cancer Center, Korea and the International Agency for Research on Cancer of the World Health Organization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
5,224
Bismuth 300 mg (4 times a day), lansoprazole 30 mg (twice a day), metronidazole 500 mg (3 times a day), and tetracycline 500 mg (4 times a day) for 10 days
Placebo for bismuth-based quadruple therapy
Kosin University Gospel Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, South Korea
The incidence of gastric cancer between the intervention and placebo groups
Histologically confirmed gastric adenocarcinoma stage 1A or more advanced defined at endoscopy or through cancer registry
Time frame: Up to 10 years After H. pylori eradication
Incidence of gastric dysplasia
Diagnosis of histologically confirmed gastric dysplasia
Time frame: Up to 10 years After H. pylori eradication
Occurrence of adverse events caused by antibiotic treatment
Solicited/unsolicited adverse events
Time frame: During 10 days of H. pylori eradication, and Up To 1 month after the treatment completion
Incidence and mortality from other medical conditions such as obesity, diabetes, circulatory diseases, oesophageal diseases as well as other cancers and cognitive impairment
Assessed through record linkage or direct assessment during screening visits
Time frame: Up to 10 years After H. pylori eradication
Mortality from gastric cancer
Cancer registry or other reports
Time frame: Up to 10 years after eradication
All-cause mortality
Korean National Health Insurance records or other reports
Time frame: Up to 10 years After H. pylori eradication
Modification of atrophy score
Change in histologic atrophy grade from enrollment to subsequent endoscopic assessment
Time frame: Up to 10 years After H. pylori eradication
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Kyungpook National University Hospital
Daegu, South Korea
National Cancer Center
Goyang, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Incheon St.Mary's Hospital/The Catholic University
Incheon, South Korea
Kandong Sacred Heart Hospital
Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, South Korea
Chung-Ang University Hospital
Seoul, South Korea
...and 1 more locations