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临床试验/NCT01065324
NCT01065324Unknown不适用

Intestinal Barrier Permeability Defects, Recovery, and Risk of Bacterial Translocation Induced After Deep Intestinal Manipulation by Balloon-assisted Enteroscopy: From Basic to Clinical Research

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
molecular bacteremia

研究概览

简要总结

  1. Balloon-assisted enteroscopy (BAE) is a new tool to investigate small intestinal diseases.
  2. Deep enteroscopy made possible by balloon expansion and manipulation of small intestines.
  3. However, whether intestinal barrier injured during BAE predispose patients to bacteremia or clinical relevant infection is not studied.
  4. We will also examine relevant patient factors.

详细描述

The newly developed balloon-assisted enteroscopy systems allow insertion of the enteroscopy deeply into the small intestines by fixation of the soft, redundant small intestines with an inflatable balloon over the tip of the overtube. However, the inflation of balloon might stimulate the intestinal mucosa, and the deep manipulation of intestinal segments might also compromise the intestinal barrier function. According to our preliminary experience of balloon-assisted enteroscopy (which is among the first groups in Taiwan), we experienced a significant case of suspected post-procedural bactermia patient. Besides, there is also a published case report from the UK reporting Streptococcus milleri bacteremia which is suspected as bacterial translocation after balloon-assisted enteroscopy. However, currently there is no original study focusing on the intestinal barrier / permeability defects or bacterial translocation. This is a timely and novel research topic in the current developing era of balloon-assisted enteroscopy.

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
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients with clinical suspicions of small intestinal lesions in need of balloon-assisted enteroscopy examinations
  • signed written informed consents

排除标准

  • Patients with active infection or receiving systemic (oral or intravenous) antibiotics within recent 3 months (this may decrease effect of bacterial translocation) or taking drugs that may affect renal function within 3 months
  • Unstable health condition for balloon-assisted enteroscopy (unstable hemodynamics, severe cardiopulmonary compromise)
  • Pregnancy
  • known allergy to lactulose, mannitol
  • Refuse to sign written informed consent of this study.
  • patients would be advised to hold prokinetic agents

结局指标

主要结局

molecular bacteremia

时间窗: 7d

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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