8022
document
Helicobacter pylori and gastric cancer : current status of the Austrain Czech German gastric cancer prevention trial ( PRISMA Study ) . AIM To test the hypothesis that Helicobacter pylori eradication alone can reduce the incidence of gastric cancer in a subgroup of individuals with an increased risk for this fatal disease . METHODS It is a prospective , randomized , double blind , placebo controlled multinational multicenter trial . Men between 55 and 65 years of age with a gastric cancer phenotype of Helicobacter pylori gastritis are randomized to receive a 7 day course of omeprazole 2 X 20mg , clarithromycin 2 X 500mg , and amoxicillin 2 X 1g for 7 days , or omeprazole 2 X 20mg plus placebo . Follow-up endoscopy is scheduled 3 months after therapy , and thereafter in one-year intervals . Predefined study endpoints are gastric cancer , precancerous lesions ( dysplasia , adenoma ) , other cancers , and death . RESULTS Since March 1998 , 1524 target patients have been screened , 279 patients ( 18.3 % ) had a corpus dominant type of H. pylori gastritis , and 167 of those were randomized ( 58.8 % ) . In the active treatment group ( r = 86 ) , H. pylori infection infection was cured in 88.9 % of patients . Currently , the cumulative follow-up time is 3046 months ( 253.38 patient years , median follow up 16 months ) . So far , none of the patients developed gastric cancer or any precancerous lesion . Three ( 1.8 % ) patients reached study endpoints other than gastric cancer . CONCLUSION Among men between 55 and 65 years of age , the gastric cancer phenotype of H. pylori gastritis appears to be more common than expected . Further follow up and continuing recruitment are necessary to fulfil the main aim of the study .
8023
Intervention_Control
placebo
8024
Intervention_Pharmacological
omeprazole 2 X 20mg
8025
Intervention_Pharmacological
clarithromycin 2 X 500mg
8026
Intervention_Pharmacological
amoxicillin 2 X 1g
8027
Intervention_Control
omeprazole 2 X 20mg
8028
Intervention_Control
placebo
8029
Outcome_Physical
gastric cancer
8030
Outcome_Physical
gastric cancer
8031
Outcome_Physical
precancerous lesions ( dysplasia , adenoma ) , other cancers
8032
Outcome_Mortality
death
8033
Outcome_Other
cured
8034
Outcome_Physical
gastric cancer
8035
Outcome_Physical
any precancerous lesion
8036
Outcome_Physical
gastric cancer
8037
Participant_Condition
Austrain Czech German gastric cancer
8038
Participant_Condition
subgroup of individuals with an increased risk for this fatal disease .
8039
Participant_Condition
Men between 55 and 65 years of age with a gastric cancer phenotype of Helicobacter pylori gastritis are randomized