Http://www.thelancet.com/journals/lancet/article/piis0140673608

The Lancet 2008; 372:392-397
Articles
Effect of eradication of Helicobacter pylori on incidence of metachronous gastric
carcinoma after endoscopic resection of early gastric cancer: an open-label, randomised
controlled trial
Kazutoshi FukaseMD a, Mototsugu KatoMD b, Shogo KikuchiMD c, Kazuhiko InoueMD d, Naomi UemuraMD e,
Shiro OkamotoMD f, Shuichi TeraoMD g, Kenji AmagaiMD h, Shunji HayashiMD i and Dr Masahiro AsakaMD
‡Members listed at end of paper
Background
The relation between Helicobacter pylori infection and gastric cancer has been proven in epidemiological studies and animal experiments. Our aim was to investigate the prophylactic effect of H pylori eradication on the development of metachronous gastric carcinoma after endoscopic resection for early gastric cancer. In this multi-centre, open-label, randomised controlled trial, 544 patients with early gastric cancer, either newly diagnosed and planning to have endoscopic treatment or in post-resection follow-up after endoscopic treatment, were randomly assigned to receive an H pylori eradication regimen (n=272) or control (n=272). Randomisation was done by a computer-generated randomisation list and was stratified by whether the patient was newly diagnosed or post-resection. Patients in the eradication group received lansoprazole 30 mg twice daily, amoxicillin 750 mg twice daily, and clarithromycin 200 mg twice daily for a week; those in the control group received standard care, but no treatment for H pylori. Patients were examined endoscopically at 6, 12, 24, and 36 months after allocation. The primary endpoint was diagnosis of new carcinoma at another site in the stomach. Analyses were by intention to treat. This trial is registered with the UMIN Clinical Trials Registry, number UMIN000001169. Findings
At 3-year follow-up, metachronous gastric carcinoma had developed in nine patients in the eradication group and 24 in the control group. In the full intention-to-treat population, including all patients irrespective of length of follow-up (272 patients in each group), the odds ratio for metachronous gastric carcinoma was 0·353 (95% CI 0·161–0·775; p=0·009); in the modified intention-to-treat population, including patients with at least one post-randomisation assessment of tumour status and adjusting for loss to follow-up (255 patients in the eradication group, 250 in the control group), the hazard ratio for metachronous gastric carcinoma was 0·339 (95% CI 0·157–0·729; p=0·003). In the eradication group, 19 (7%) patients had diarrhoea and 32 (12%) had soft stools. Interpretation
Prophylactic eradication of H pylori after endoscopic resection of early gastric cancer should be used to prevent the development of metachronous gastric carcinoma. Affiliations
http://www.thelancet.com/journals/lancet/article/PIIS0140673608611599/abstractprint. 23.09.2008 a. Department of Gastroenterology, Yamagata Prefectural Central Hospital, Yamagata, Japan b. Division of Endoscopy, Hokkaido University Hospital, Sapporo, Japan c. Department of Public Health, Aichi Medical University School of Medicine, Aichi, Japan d. Department of Gastroenterology, Matsue Red Cross Hospital, Matsue, Japan e. Department of Endoscopy, International Medical Center of Japan, Tokyo, Japan f. Department of Gastroenterology, Kure Kyosai Hospital, Kure, Japan g. Department of Gastroenterology, Kyoto Min-I-Ren Chuoh Hospital, Kyoto, Japan h. Department of Gastroenterology, Ibaraki Prefectural Central Hospital, Ibaraki, Japan i. Department of Infection and Immunity, Jichi Medical University, Shimotsuke, Japan j. Department of Gastroenterology, Hokkaido University Graduate School of Medicine, Sapporo, Japan Correspondence to: Dr M Asaka, Department of Gastroenterology, Hokkaido University Graduate School of Medicine, North 14, West 7, Kita- http://www.thelancet.com/journals/lancet/article/PIIS0140673608611599/abstractprint. 23.09.2008

Source: http://www.mcbonn.de/infos/www.mcbonn.de_%20Effect_of_eradication_of_Helicobacte_%20pylori.pdf