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临床试验/NCT01945177
NCT01945177已完成不适用

A Randomized Comparison Between White Light Endoscopy (WLE) and Bright Narrow Band Imaging (B-NBI) in Subjects Undergoing Upper Gastrointestinal Endoscopy

Changi General Hospital2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
2
主要终点
Detection rate of intestinal metaplasia

研究概览

简要总结

It is recognized that gastroscopy can miss intestinal metaplasia, dysplasia and early gastric cancer. This could conceivably be due to the fact that these lesions may only present as subtle mucosal changes on conventional white light endoscopy (WLE) and thus be easily missed. In narrow band imaging (NBI) a rotating interference narrow band filter is interposed after the xenon light source such that when the NBI mode is switched on, discrete blue and green wavelengths are used and this improves mucosal surface contrast and facilitates visualization of mucosal details. A new NBI system is available that allows brighter illumination. We hypothesize that bright -NBI is superior to WLE in detecting focal gastric lesions such as gastric intestinal metaplasia, dysplasia and early gastric cancer in subjects undergoing gastroscopy.

详细描述

Background It is recognized that gastroscopy can miss intestinal metaplasia, dysplasia and early gastric cancer (EGC)[1-3]. This could conceivably be due to the fact that EGC, as well as premalignant changes, may only present as subtle mucosal changes on conventional white light endoscopy (WLE) and thus be easily missed.

Chromoendoscopy has been used routinely in some centers during upper gastrointestinal (UGI) endoscopy in an attempt to improve mucosal contrast and detect subtle mucosal lesions[4]. However, this is not the norm in most centers due to the inconvenience of dye spray. Narrow band imaging (NBI) facilitates the examination of the mucosal surface without a need for chromoendoscopy. It is based on the principle that the depth of penetration of light is wavelength dependent, with shorter wavelengths resulting in more superficial penetration i.e. blue light penetrates most superficially (mucosal imaging) while red light penetrates the deepest (submucosal imaging). In NBI a rotating interference narrow band filter is interposed after the xenon light source such that when the NBI mode is switched on, discrete blue and green wavelengths are used and this improves mucosal surface contrast and facilitates visualization of mucosal details[5]. Magnifying endoscopy (ME) is useful in assessing the gastric mucosal pit pattern and microvessel of gastric mucosal lesions, thus providing the possibility of predicting the histological nature of the mucosal lesion. Studies from Japan, a country with a high population risk for gastric cancer, which were based on preselected high risk patients or patients with known precancerous lesions or EGC, showed that NBI and NBI-ME could diagnose precancerous lesions such as intestinal metaplasia (IM)[6] as well as EGC[7-11].

However, there is a lack of published data on the clinical utility of NBI in the detection of gastric intestinal metaplasia, dysplasia and EGC in the unselected general population. A recent study from Singapore looked at the utility of NBI and NBI-ME in patients aged 35 to 70 years undergoing diagnostic UGI endoscopy and found that the detection rate of focal lesions was increased from 43.7% to 58.8% with NBI, compared to WLE. Among the additional lesions detected, NBI-ME identified 97.1% as IM, 1.4% as EGC and 1.4% as benign. The EGC was a synchronous cancer missed by WLE but detected by NBI[12].

The current NBI system is limited by the dark endoscopic view. This has the potential limitation of making the detection of subtle lesions more difficult and lesions could be missed. A new prototype NBI system has been designed that has a brighter appearance. This prototype bright NBI coupled with high definition resolution is likely to overcome this drawback of original NBI.

Hypothesis We hypothesize that bright -NBI is superior to WLE in detecting focal gastric lesions such as gastric intestinal metaplasia, dysplasia and EGC in subjects undergoing diagnostic upper GI endoscopy.

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects aged > 50 years undergoing diagnostic or screening upper GI endoscopy
  • ability to provide a written consent to trial participation.

排除标准

  • presence of active gastrointestinal bleeding
  • presence of coagulopathy precluding biopsies
  • absence of informed consent.

结局指标

主要结局

Detection rate of intestinal metaplasia

时间窗: At the point of gastroscopy

Detection rate of intestinal metaplasia by white light endoscopy and by narrow band imaging

次要结局

  • Aggregate detection rate of focal gastric lesions(At completion of gastroscopy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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