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临床试验/NCT02594813
NCT02594813招募中不适用

Bleeding Rate After EGD and Colonoscopy in Patients Who Continue to Take Antithrombotic Agents

Showa Inan General Hospital1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
the rate of delayed bleeding

研究概览

简要总结

The bleeding rate of both EGD (including biopsy) and colonoscopy (including biopsy, cold or hot snare polypectomy, or EMR) in patients who continue to take various antithrombotic drugs is studied prospectively. The immediate or delayed bleeding that requires hemostatic clipping or other endoscopic treatments is defined as the bleeding. Immediate bleeding requiring hemostatic clipping is defined as spurting or oozing which continued for more than 30 seconds. Delayed bleeding is defined as bleeding that requires the endoscopic treatment within 2 weeks after endoscopy. Prophylactic clipping is not performed after taking biopsy and doing polypectomy. Additionally, investigators evaluate the rate of injured submucosal arteries of the excised specimen when the bleeding occurs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria is all patients who continue to take antithrombotic drugs and undergo EGD or colonoscopy

排除标准

  • Patients who take prophylactic clipping after biopsy or polypectomy American Society of Anesthesiologists physical status of class IV or V

结局指标

主要结局

the rate of delayed bleeding

时间窗: 10 years

Delayed bleeding defined as bleeding that required endoscopic treatment within 2 weeks after the procedure.

次要结局

  • the number of clip used(10 years)
  • the rate of immediate bleeding(10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Akira Horiuchi

Chief

Showa Inan General Hospital

研究点 (1)

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