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临床试验/NCT05935124
NCT05935124招募中不适用

A Randomized Comparison Between White Light Endoscopy (WLE) and Bright Narrow Band Imaging (B-NBI) in the Diagnosis of Right Sided Colonic Polyps in Asymptomatic Subjects Undergoing Screening Colonoscopy

Western Sydney Local Health District2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2015年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
600
试验地点
2
主要终点
Rate of right sided polyp detection with WLE and B-NBI

研究概览

简要总结

A randomized controlled crossover study to determine if narrow band imaging or white light endoscopy is superior in detecting right colonic polyps in average risk subjects undergoing screening colonoscopy

详细描述

Removal of colorectal adenomas prevents occurrence of cancers. It is recognized that colonoscopy can miss colorectal adenomas and early cancers. Proximal colon polyp detection rate is lower compared to distal colon detection rates. This may be partially due to the higher prevalence of flat polyps and sessile serrated adenomas (SSAs) which are harder to visualize. There is a need to further improve performance of colonoscopy. A second evaluation of the right colon within the same procedure may yield an additional detection rate of 5-10%, however retro-flexion has not proven to be superior to a second forward viewing examination. The use of chromo-endoscopy has been shown to improve detection of flat adenomas. Narrow band imaging was introduced in year 2006. It is similar to chromo-endoscopy 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 chromo-endoscopy. In pooled analysis, NBI is comparable to chromo-endoscopy in their sensitivity and specificity in the diagnosis of malignant colorectal adenomas. 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. 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.

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
Diagnostic
盲法
Single (Participant)

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

  • Asymptomatic subjects undergoing screening colonoscopy
  • average risk subjects defined as those without a personal history of inflammatory bowel disease, colon adenoma or cancer or family history of FAP or Familial non-polyposis syndrome or first degree relatives having diagnosed to have colo-rectal carcinoma, no colonoscopy in past 5 years and, ability to provide a written consent to trial participation

排除标准

  • unable to consent

结局指标

主要结局

Rate of right sided polyp detection with WLE and B-NBI

时间窗: 1 day

次要结局

  • Rate of the detection of SSPs in the right colon with WLE and B-NBI(1 day)

研究者

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

Professor Michael Bourke

Director of Endoscopy

Western Sydney Local Health District

研究点 (2)

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