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.
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
Prophylactic eradication of H pylori after endoscopic resection of early gastric cancer should be used to prevent the development of metachronous gastric carcinoma.


BACKGROUND
Hiroshima Cancer Seminar Foundation.
Fukase
Kazutoshi
K
Department of Gastroenterology, Yamagata Prefectural Central Hospital, Yamagata, Japan.
Kato
Mototsugu
M
Kikuchi
Shogo
S
Inoue
Kazuhiko
K
Uemura
Naomi
N
Okamoto
Shiro
S
Terao
Shuichi
S
Amagai
Kenji
K
Hayashi
Shunji
S
Asaka
Masahiro
M
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use*; D000368:Aged; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D017291:Clarithromycin / Q000627:therapeutic use*; D016099:Endoscopy, Gastrointestinal; D023381:Endpoint Determination; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects / Q000472:pathogenicity*; D006801:Humans; D007564:Japan; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000473:pathology* / Q000517:prevention & control; D013274:Stomach Neoplasms / Q000209:etiology / Q000517:prevention & control* / Q000601:surgery
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000890:Anti-Infective Agents; D064747:Lansoprazole; D017291:Clarithromycin