跳至主要内容
临床试验/NCT01504048
NCT01504048Unknown不适用

Prospective Study on the Usefulness of Chromoendoscopy in Detecting Microscopic Colitis in Patients Undergoing Colonoscopy Due to Chronic Watery Diarrhoea

Karolinska University Hospital2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2009年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
2
主要终点
Detection of microscopic colitis using chromoendoscopy

研究概览

简要总结

The purpose of this study is to determine whether chromoendoscopy using Indigo-Carmine dye spray is useful in diagnosing microscopic colitis among patients undergoing colonoscopy due to chronic watery diarrhea.

详细描述

Microscopic colitis is a common disease found in 10% to 20% of cases having chronic watery diarrhea. Obvious endoscopically identifiable changes of the mucosal surface are usually absent, thus diagnosing microscopic colitis relies on multiple biopsy sampling from all segments of the colon. Chromoendoscopy using indigo-carmine dye spray might, however, unravel mucosal changes in microscopic colitis (Suzuki 2011).

The aim of this study is to investigate if chromoendoscopy using Indigo-Carmine 0.2-0.5% in patients with chronic watery diarrhea is useful in diagnosing microscopic colitis.

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 with chronic non-bloody diarrhea for at least one month

排除标准

  • Patients who decline to participate
  • Unable to give informed consent

研究组 & 干预措施

Chromoendoscopy

Experimental

干预措施: Colonoscopy with Indigo-Carmine Chromoendoscopy (Procedure)

结局指标

主要结局

Detection of microscopic colitis using chromoendoscopy

时间窗: 12 month

To investigate the usefullness of chromoendoscopy in diagnosing microscopic colitis using 0.2-0.5% Indigo-Carmine dye spray. The golden standard is the results of histological examination of biopsies from the colo-rectal mucosa.

次要结局

未报告次要终点

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Thelin Schmidt

Head of Endoscopy

Karolinska University Hospital

研究点 (2)

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