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临床试验/NCT01737567
NCT01737567撤回不适用

A Randomised Comparison Between White Light Endoscopy (WLE) and Bright Narrow Band Imaging (B-NBI) in the Diagnosis of Colonic Adenomas in Asymptomatic Subjects Undergoing Screening Colonoscopy.

Professor Michael Bourke2 个研究点 分布在 1 个国家开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Improvement in detection of colorectal adenomas.

研究概览

简要总结

Removal of colorectal adenomas prevents the occurence of colorectal cancers. The use of chromo-endoscopy has been shown to improve the detection of flat adenomas. Narrow band imaging enables endoscopists to accurately describe the pit pattern of adenomas. By comparing White Light Endoscopy and Bright Narrow Band Imaging it will show if there is any comparable advantage to using one or the other for lesion detection and assessment.

详细描述

Removal of colorectal adenomas prevents occurrence of cancers [1]. It is recognized that colonoscopy can miss colorectal adenomas and early cancers [2]. There is a need to further improve performance of colonoscopy. The use of chromoendoscopy has been shown to improve detection of flat adenomas [3]. Narrow band imaging was introduced in year 2006. It is similar to chromoendoscopy in that it provides more mucosal details. This enables endoscopists to accurately describe the pit pattern of adenomas. NBI has been used as a substitute to chromoendoscopy.

In pooled analysis, NBI is comparable to chromoendoscopy in their sensitivity and specificity in the diagnosis of malignant colorectal adenomas [4]. Unfortunately, the use of NBI has not been shown to conclusively improve rate of colorectal adenoma detection. Two of 3 randomized trials that compared WLE to NBI showed a higher adenoma detection rate with the use of NBI [5, 6]. In a study by Rex et al., the rate was however similar with either modality. In a pooled analysis, NBI was only marginally better than WLE [7].

The effective use of NBI depends on the quality of bowel preparation and the experience of endoscopist. In the presence of fecal matters, NBI tends to be dark and detection of small adenomas becomes difficult. The prototype bright NBI coupled with high definition resolution is likely to overcome this drawback of original NBI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
50 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Asymptomatic subjects undergoing screening colonoscopy, age > 50, average risk subjects and, ability to provide a written consent to trial participation.

排除标准

  • personal history of inflammatory bowel disease, colon adenoma or cancer
  • family history of FAP or Familial nonpolyposis syndrome
  • first degree relatives having diagnosed to have colorectal carcinoma
  • no colonoscopy in past 5 years

结局指标

主要结局

Improvement in detection of colorectal adenomas.

时间窗: One year

It is anticipated that colorectal adenomas will be more easily identifiable using Bright Narrow Band Imaging.

次要结局

  • Improvement of histological prediction(One year)

研究者

发起方
Professor Michael Bourke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Professor Michael Bourke

Director of Gastrointestinal Endoscopy

Western Sydney Local Health District

研究点 (2)

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