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临床试验/NCT02219568
NCT02219568已完成不适用

Efficacy of Wireless Capsule Endoscopy and CT Enterography in Obscure Gastrointestinal Bleeding : Prospective Blinded Comparative Study

Mahidol University2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
2
主要终点
number of significant gastrointestinal lesions detected

研究概览

简要总结

The purpose of this study is to compare the efficacy between video capsule endoscopy and CT enterography in diagnosis of obscure gastrointestinal bleeding.

详细描述

All adult patients with obscure gastrointestinal bleeding will undergo both video capsule endoscopy and CT enterography. The interval between two tests will be less than 1 month. The capsule reading gastroenterologist and the CT reading radiologist are blinded to each others' results.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • patients who present with passing melena or hematochezia or have iron deficiency anemia
  • no lesion found on both esophagogastroduodenoscopy and colonoscopy
  • age at least 18 years

排除标准

  • allergy to iodinated intravenous contrast
  • chronic kidney disease stage at least 3 patients who do not on regular dialysis
  • suspected small bowel obstruction

结局指标

主要结局

number of significant gastrointestinal lesions detected

时间窗: up to 1 month

Significant gastrointestinal lesions are ulcers, mucosal inflammation, angiodysplasia, and mass.

次要结局

未报告次要终点

研究者

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

Julajak Limsrivilai

Instructor in Internal medicine, Gastroenterlogy Division, Siriraj Hospital

Mahidol University

研究点 (2)

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