Jeongmin Choi1, Sang Gyun Kim2, Hyuk Yoon1, Jong Pil Im1, Joo Sung Kim1, Woo Ho Kim3, Hyun Chae Jung1. 1. Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea. 2. Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea. Electronic address: harley1333@hanmail.net. 3. Department of Pathology, Seoul National University College of Medicine, Seoul, Korea.
Abstract
BACKGROUND & AIMS: It is not clear whether eradication of Helicobacter pylori infection reduces the risk for metachronous gastric carcinoma. We performed a prospective, randomized, open-label trial of the effects of H pylori eradication on the incidence of metachronous carcinoma after endoscopic resection of gastric tumors. METHODS:From April 2005 through February 2011 there were 901 consecutive patients with H pylori infection who had been treated with endoscopic resection for gastric dysplasia or cancer and who were assigned randomly to groups given therapy to eradicate the infection (n = 444) or no therapy (controls, n = 457). The eradication group received 20 mg omeprazole, 1 g amoxicillin, and 500 mg clarithromycin twice daily for 1 week. Patients underwent endoscopic examination 3, 6, and 12 months after treatment, and then yearly thereafter. The primary outcome was development of metachronous gastric carcinoma. RESULTS: During a median follow-up period of 3 years, 10 patients who received H pylori eradication and 17 controls developed metachronous carcinoma; this difference was not significant (P = .15). The incidence of metachronous carcinoma between the 2 groups did not differ significantly at 1, 2, 3, and 4 years after administration of the therapy. There were no significant differences in the development of metachronous carcinoma among patients who were positive (n = 16) or negative (n = 11) for H pylori infection (P = .32). CONCLUSIONS: In this prospective trial, eradication of H pylori after endoscopic resection of gastric tumors did not significantly reduce the incidence of metachronous gastric carcinoma. ClinicalTrials.gov Number: NCT01510730.
RCT Entities:
BACKGROUND & AIMS: It is not clear whether eradication of Helicobacter pyloriinfection reduces the risk for metachronous gastric carcinoma. We performed a prospective, randomized, open-label trial of the effects of H pylori eradication on the incidence of metachronous carcinoma after endoscopic resection of gastric tumors. METHODS: From April 2005 through February 2011 there were 901 consecutive patients with H pylori infection who had been treated with endoscopic resection for gastric dysplasia or cancer and who were assigned randomly to groups given therapy to eradicate the infection (n = 444) or no therapy (controls, n = 457). The eradication group received 20 mg omeprazole, 1 g amoxicillin, and 500 mg clarithromycin twice daily for 1 week. Patients underwent endoscopic examination 3, 6, and 12 months after treatment, and then yearly thereafter. The primary outcome was development of metachronous gastric carcinoma. RESULTS: During a median follow-up period of 3 years, 10 patients who received H pylori eradication and 17 controls developed metachronous carcinoma; this difference was not significant (P = .15). The incidence of metachronous carcinoma between the 2 groups did not differ significantly at 1, 2, 3, and 4 years after administration of the therapy. There were no significant differences in the development of metachronous carcinoma among patients who were positive (n = 16) or negative (n = 11) for H pylori infection (P = .32). CONCLUSIONS: In this prospective trial, eradication of H pylori after endoscopic resection of gastric tumors did not significantly reduce the incidence of metachronous gastric carcinoma. ClinicalTrials.gov Number: NCT01510730.