Background and Aims

Whether eradication of Helicobacter pylori reduces the incidence of metachronous gastric cancer (MGC) is still debatable. We aimed to evaluate the long-term effect of H pylori eradication on the development of MGC after endoscopic gastric tumor resection.

Methods

We undertook an open-label, prospective, randomized controlled trial at a tertiary hospital in Seoul, Korea. Participants were recruited during April 2005 to February 2011 and followed until December 2016. We assigned 898 patients with H pylori infection treated with endoscopic resection (ER) for gastric dysplasia or early gastric cancer to receive (n =442) or not receive (n =456) eradication therapy using a random-number chart. Eradication group patients received oral omeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily for a week, whereas control group patients received no H pylori treatment. The primary outcome was the incidence of MGC (intention-to-treat analysis).

Results

The 877 patients who attended ≥1 follow-up examination (eradication group, 437; control group, 440) were analyzed. Median follow-up was 71.6 months (interquartile range, 42.1-90.0). MGC developed in 18 (4.1%) eradication and 36 (8.2%) control group patients (log-rank test, P = .01). In our yearly analysis, the effect of eradication showed a significant difference in 5 years after allocation (log-rank test, P = .02). The adjusted hazard ratio for the control group was 2.02 (95% CI, 1.14-3.56; P = .02), compared with the eradication group.

Conclusions

H pylori eradication significantly reduces the incidence of MGC after ER of gastric tumors and should be considered for H pylori–positive gastric tumor patients treated with ER. (Clinical trial registration number: NCT01510730.)

中文翻译：

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的影响幽门螺杆菌根除对胃癌异时防癌：一项随机对照试验

背景和目标

根除幽门螺杆菌是否可以降低异时性胃癌（MGC）的发病率仍有争议。我们旨在评估根除幽门螺杆菌对内镜胃肿瘤切除术后MGC发生的长期影响。

方法

我们在韩国首尔的一家三级医院进行了一项开放性，前瞻性，随机对照试验。参加者为2005年4月至2011年2月，然后随访至2016年12月。我们分配了898例接受内镜切除术（ER）治疗的胃异型增生或早期胃癌的幽门螺杆菌感染患者（n = 442）或未接受（n = 456）使用随机数图表进行根除治疗。根除组患者每周两次口服口服奥美拉唑20 mg，阿莫西林1 g和克拉霉素500 mg，一周，而对照组患者未接受幽门螺杆菌治疗。主要结果是MGC的发生率（意向性治疗分析）。

结果

分析了参加≥1次随访检查的877例患者（根除组437例；对照组440例）。中位随访时间为71.6个月（四分位间距为42.1-90.0）。MGC在18例（4.1％）的根除和36例（8.2％）的对照组患者中发展（对数秩检验，P  = 0.01）。在我们的年度分析中，根除的效果在分配后的5年内显示出显着差异（对数秩检验，P  = .02）。 与根除组相比，对照组的调整后风险比为2.02（95％CI，1.14-3.56；P = .02）。

结论

根除幽门螺杆菌可显着降低胃肿瘤内镜治疗后MGC的发生率，对于接受内科治疗的幽门螺杆菌阳性胃肿瘤患者应考虑。（临床试验注册号：NCT01510730。）