跳至主要内容
临床试验/NCT01976351
NCT01976351终止不适用

Imaging Enhanced Endoscopy for the Screening of Barrett's Esophagus and Evaluation of Its Invasiveness in Patients With Gastroesophageal Reflux Disease

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
51
试验地点
1
主要终点
The relationship between the mucosal morphology by imaging enhanced endoscopy and the presence of high-grade intraepithelial neoplasia from non-dysplastic specialized intestinal metaplasia.

研究概览

简要总结

Imaging enhanced endoscopy can improve the efficacy of screening of Barrett's esophagus and predict its invasiveness. There is potentially molecular change over the Barrett's esophagus in this Chinese population.

To evaluate the efficacy of imaging enhanced endoscopy for screening of Barrett's esophagus and evaluation of invasiveness

详细描述

Barrett ' s esophagus, defined as a pathological finding of metaplastic change of esophageal mucosa from squamous to columnar epithelium, is a tongue-like extension of salmon-colored mucosa from the gastroesophageal junction by endoscopy (1 2,3) . Endoscopic abnormalities suggestive of BE which has not been confirmed by histology, are defined as endoscopically suspected esophageal metaplasia (ESEM) (2). Barrett's esophagus is considered a precancerous lesion of esophageal adenocarcinoma (4 5) and it's mandatory for accurate diagnosis of BE. The pathogenesis of BE has also been closely associated with gastroesophageal reflux disease (6). In Western countries the reported prevalence of BE has varied from 0.9 to 4.5 % (3,7,8) in the general population and 6.3 to 13.6 % (9 - 12) in patients with GERD. For reliably rating differences of severity of endoscopically identified lesions among studies or quantify progression or regression of BE, International Working Group for the Classification of Oesophagitis (IWGCOA) proposed new classification of BE, the Prague C and M criteria (13) for defining the extent of BE based on the circumference (C) and maximum (M) of the lesion. This standard grading system could allow comparison of the severity of BE and aid in following the natural course of BE Image-enhanced endoscopy (IEE) compromises various means of enhancing contrast during endoscopy using dye, optical, and/or electronic methods IEE allows improved visualization of lesions and can be used to gain insight into the pathology of the lesion, Recent progress in optics and computerized processing of endoscopic images, such as narrow band image (NBI) and Fuji intelligent Chromoendoscopy (FICE), provide an optical and/or electronic enhancement of the mucosal structures. Most recently, the EPKi-processor (Pentax, Tokyo, Japan) developed i-Scan, a novel endoscopic post-processing light filter technology using delicate software algorithms with real-time image mapping technology, which can provide detailed analysis based on vessel (i-Scan V), pattern (i-Scan P), or surface architecture (i-Scan SE). Resolution of about 1.25 mega pixels per image could be provided by the computer-controlled digital processing. The SE-mode could be used for the identification of the morphological changes of esophageal mucosa. Accordingly, i-Scan e- and b-modes could be used to further evaluate the lesions, such as the regularity of vascular pattern and the presence of the abnormal vessels.

According to previous study (14), Ki67 and p53 immuno-histochemistry could reduce interobserver variation in assessment of Barrett's oesophagus. These IHC methods correlate with the severity of dysplasia very well and are useful supplementary prognostic markers In our study, we use the image enhanced endoscopy to observe the endoscopically suspected esophageal metaplasia and record it with Prague C and M criteria grading system. Immuno-histochemical staining was used as supplementary prognostic markers. Our aim is to evaluate the efficacy of imaging enhanced endoscopy for screening of Barrett's esophagus and evaluation of invasiveness.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • suspected or a history of Barrett's esophagus for endoscopic exam

排除标准

  • younger than 20 years of age
  • patients with esophageal or cardiac varices
  • pregnant women.

结局指标

主要结局

The relationship between the mucosal morphology by imaging enhanced endoscopy and the presence of high-grade intraepithelial neoplasia from non-dysplastic specialized intestinal metaplasia.

时间窗: Up to one month

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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