The efficacy of Leukotriene receptor antagonist for human rectal aberrant crypt foci: nonrandomized open label controlled trial

Misawa Noboru0 个研究点目标入组 40 人开始时间: 2019年1月25日最近更新: 2023年10月17日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 40

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

During the study period, 30 patients in the LTRA group and 10 patients in the no-treatment follow-up group were enrolled. In the LTRA group, the number of ACF decreased significantly from 7.9 +/- 3.0 (pre-treatment) to 5.5 +/- 3.3 (post-treatment, after 8 weeks of LTRA treatment) (p<0.001). While the number of ACFs in the no-treatment follow-up group was 11.0 +/- 5.4 at the baseline to 11.4+/- 5.8 after 8 weeks, no significant change the number of ACFs was observed (p=0.578).

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 30age old 至 < 80age old（—）
性别: All

入选标准

•1.Patients with resectable polyps.
•2.Patients with more than 5 rectal ACF
•3.Willingness to provide written informed consent

排除标准

•1.Patients with lesion which preferred early resection.
•2.History of use of LTRA within 2months before trial entry.
•3.History of malignant disease within 5 yeears before trial entry.
•4.History of heart failure, renal failure, liver cirrhosis or chronic hepatic failure
•5.History of familial adenomatous polyposis, hereditary non-polyposis colorectal cancer and inflammatory bowel disease
•6.Pregnancy or possibility of pregnancy
•7.Contraindication to Montelukast
•8.Allergy to Montelukast
•9.Patients judged as inappropriate candidates for the trial by the investigators

研究者

发起方

Misawa Noboru

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