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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

N = 544

Population
Patients with early gastric cancer, newly diagnosed and planning endoscopic treatment or in follow-up after endoscopic resection.
Design
Multi-centre, open-label randomised trial of 544 patients with early gastric cancer (newly diagnosed and planning endoscopic treatment, or in post-resection follow-up): H. pylori eradication (lansoprazole, amoxicillin, clarithromycin for a week; n = 272) or no H. pylori treatment (n = 272). Endoscopy at 6, 12, 24 and 36 months. Primary endpoint: diagnosis of new carcinoma at another site in the stomach. Registered as UMIN000001169.
Primary endpoint
Metachronous gastric cancer
Arms
  • Control (control, n = 272): Standard care, no H. pylori treatment
  • H. pylori eradication (experimental, n = 272): Lansoprazole 30 mg, amoxicillin 750 mg and clarithromycin 200 mg, each twice daily for a week
People
Fukase K, senior author Japan Gast Study Group
Metachronous gastric cancerHR 0.339 (95% CI 0.157–0.729)
Show the numbers
Results reported for 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
EndpointAnalysisH. pylori eradicationControlEffect
Metachronous gastric cancerModified ITT: patients with at least one post-randomisation tumour assessment, adjusted for loss to follow-up (255 eradication, 250 control)primaryFukase 2008——HR 0.339 (95% CI 0.157–0.729)P=0.003In the full ITT population (272 per arm) the abstract gives an odds ratio of 0.353 (95% CI 0.161 to 0.775; p=0.009), with metachronous carcinoma in nine patients in the eradication group and 24 in the control group at 3 years.
Results reported for 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
EndpointAnalysisH. pylori eradicationControlEffect
Metachronous gastric cancerModified ITT: patients with at least one post-randomisation tumour assessment, adjusted for loss to follow-up (255 eradication, 250 control)primaryFukase 2008——HR 0.339 (95% CI 0.157–0.729)P=0.003In the full ITT population (272 per arm) the abstract gives an odds ratio of 0.353 (95% CI 0.161 to 0.775; p=0.009), with metachronous carcinoma in nine patients in the eradication group and 24 in the control group at 3 years.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
Metachronous gastric cancer0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
Metachronous gastric cancer0.3390.157–0.729
Primary publication: Fukase K, Kato M, Kikuchi S, Inoue K, Uemura N, Okamoto S, et al. 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. Lancet. 2008;372(9636):392-7. PubMedDOI

Appears in

Sources

  1. Fukase K, Kato M, Kikuchi S, Inoue K, Uemura N, Okamoto S, et al. 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. Lancet. 2008;372(9636):392-7.

    PubMedDOI