跳至主要内容
临床试验/NCT01422577
NCT01422577已完成不适用

A Randomized 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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 1,006 人开始时间: 2010年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,006
试验地点
1
主要终点
Colorectal adenoma detection rate

研究概览

简要总结

Early detection of colo-rectal adenoma using colonoscopy can prevent occurrence of colon cancers. While colonoscopy is a standard technique, it can miss early cancers. To improve the detection rate, Narrow Band Imaging (NBI) was introduced in 2006. It has been shown to compare favorably with chromo-endoscopy in the sensitivity and specificity in the diagnosis of malignant colo-rectal neoplasms. The major drawback of NBI is that images become dark in the presence of blood and fecal matters. The bright-NBI is a prototype imaging technology that enables endoscopists to obtain better images in suboptimal conditions. The study proposes to compare the performance of colonoscopy using either white light or bright NBI in subjects undergoing screening colonoscopy in search for colon adenomas.

Purpose

To determine that bright -NBI is superior to WLE in detecting colorectal adenomas in average risk subjects undergoing screening colonoscopy.

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 chromo-endoscopy has been shown to improve detection of flat adenomas [3]. 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 [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 [4].

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
None

入排标准

年龄范围
40 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 Familial adenomatous polyposis (FAP) or Familial non-polyposis syndrome or first degree relatives having diagnosed to have colo-rectal carcinoma
  • no colonoscopy in past 5 years
  • ability to provide a written consent to trial participation

排除标准

  • Patient age < 50
  • Patients with prior colorectal surgery
  • Pregnant or lactating women
  • Colonoscopy done within the past 5 years
  • Lack of consent

研究组 & 干预措施

Bright Narrow Band Imaging

Active Comparator

Bright Narrow Band Imaging

干预措施: Bright Narrow Band Imaging (Device)

White Light Endoscopy

Active Comparator

White Light Endoscopy

干预措施: White light Endoscopy (Device)

结局指标

主要结局

Colorectal adenoma detection rate

时间窗: 2 years

compare the rate in colorectal adenoma detection between B-NBI and conventional colonoscopy

次要结局

  • 1. Rate in the detection of advanced neoplasms (defined by adenomas >10 mm in size, with high grade dysplasia or with >25% villous features).(2 years)
  • 2. Sensitivity and specificity of either image modality in the diagnosis of malignant adenomas using pathology(2 years)

研究者

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

James Yun-wong Lau

Professor

Chinese University of Hong Kong

研究点 (1)

Loading locations...

相似试验