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临床试验/JPRN-UMIN000002669
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Helicobacter pylori eradication therapy in gastric cancer patients who undergo pylorogastrectomy - Helicobacter pylori eradication therapy in gastric cancer patients who undergo pylorogastrectomy

The Cancer Institute Hospital of JFCR, Gastroenterological Surgery0 个研究点目标入组 300 人开始时间: 2009年11月1日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
300

研究概览

简要总结

BACKGROUND: The Maastricht, Asia-Pacific consensus guidelines strongly recommend eradication of Helicobacter pylori in patients who have a history of gastric cancer. This open-label, single-center, randomized controlled trial was conducted to investigate the appropriate timing of eradication for patients undergoing gastrectomy. STUDY DESIGN: One hundred and fifty patients scheduled to undergo gastrectomy were allocated to either a preoperative or a postoperative group. The eradication regimen was a common triple therapy: rabeprazole, amoxicillin, and clarithromycin [corrected]. Patients in the preoperative group were treated with the regimen, followed by surgery, and patients in the postoperative group were treated after postoperative day 8. The primary end point was the proportion of patients achieving successful eradication in the remnant stomach. The definition of successful eradication was negativity in both the C13 urea breath test and for the antigen in feces at 6 months after surgery. RESULTS: Eight patients were excluded, and the remaining one hundred and forty-two, 70 in the preoperative group and 72 in the postoperative group, were included on an intention to treat basis. The procedures used were gastrectomy with Billroth I, Roux-en-Y, and pylorus-preserving gastrectomy in 18, 70, and 57 patients, respectively. The proportion of patients showing successful eradication hardly differed between the 2 groups, 68.6% vs 69.4% (p = 1.000) in the pre- and postoperative groups, respectively. Subgroup analysis also demonstrated no significant difference among the reconstruction methods used. CONCLUSIONS: Preoperative H pylori eradication therapy for gastric cancer patients scheduled for gastrectomy is not necessary, regardless of the planned reconstruction procedure.

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • Recurrent gastric cancer,Previous gastric surgery,stage4,underwent total gastrectomy,history of H.pylori eradication therapy,contraindication of H.pylori triple therapy

研究者

发起方
The Cancer Institute Hospital of JFCR, Gastroenterological Surgery

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