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The objective of this study was to determine whether there is an association between <jats:italic>H. pylori<\/jats:italic> in bile and biliary tract carcinoma.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>The authors used polymerase chain reaction (PCR) assays to detect the presence of <jats:italic>H. pylori<\/jats:italic> in the stomach and bile from 89 patients: Sixty\u2010three disease free patients had biliary calculi, 15 patients had carcinoma of the biliary tract, and 11 patients had neither gallstones nor carcinoma. Bile was considered to contain <jats:italic>H. pylori<\/jats:italic> only if the results of PCR determinations were positive in two or more samples assayed independently in two separate laboratories.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>There was a strong association between the presence of <jats:italic>H. pylori<\/jats:italic> in the stomach and in the bile (<jats:italic>P<\/jats:italic> \u2264 0.01). Biliary <jats:italic>H. pylori<\/jats:italic> was associated with age but not with gender, and it was associated strongly with the clinical diagnosis. Patients with gallstones were 3.5 times as likely to have <jats:italic>H. pylori<\/jats:italic> in the bile compared with patients in a control group (95% confidence interval [95%CI], 0.8\u201315.8; <jats:italic>P<\/jats:italic> = 0.100), and <jats:italic>H. pylori<\/jats:italic> was 9.9 times more frequent in patients with biliary tract carcinoma compared with patients in the control group (95%CI, 1.4\u201370.5; <jats:italic>P<\/jats:italic> = 0.022).<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>There is a strong association between biliary tract carcinoma and <jats:italic>H. pylori<\/jats:italic> in bile. If these results are confirmed by prospective studies, <jats:italic>H. pylori<\/jats:italic> may be responsible for a significant proportion of malignant biliary tract disease. Cancer 2002;95:1946\u201353. \u00a9 2002 American Cancer Society.<\/jats:p><jats:p>DOI 10.1002\/cncr.10893<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.10893","type":"journal-article","created":{"date-parts":[[2002,10,29]],"date-time":"2002-10-29T08:57:53Z","timestamp":1035881873000},"page":"1946-1953","source":"Crossref","is-referenced-by-count":86,"title":["<i>Helicobacter pylori<\/i> and the risk of benign and malignant biliary tract 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