跳至主要内容
临床试验/NCT02033980
NCT02033980Unknown不适用

Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions ----- a Multicenter Study in China

Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
1
主要终点
Accuracy of NICE classification in histological prediction by gastroenterological fellows

研究概览

简要总结

Recently, a new category classification (NICE classification) using non-magnified NBI has been proposed. We design this multicenter study to evaluate the reliability and validity of the NICE classification in diagnosing colorectal polyps by Chinese endoscopists during both image and real-time process.

详细描述

Many reports have demonstrated the efficacy of narrow band imaging (NBI) with magnification in predicting the histology and invasion depth of colorectal polyps. In China, however, the magnifying endoscope is not used in some medical centers. Even in centers equipped with this technique, the magnifying colonoscope is not sufficiently used in daily practice. Recently, a simple category classification (NICE classification) using non-magnified NBI has been proposed, which classifies colorectal tumors into types 1-3 based on different characteristics of color, surface pattern, and microvessels. Type-1 is considered an index for hyperplastic lesions, type-2 is an index for adenoma or mucosal/SM scanty invasive carcinoma and type-3 is an index for deep SM invasive carcinoma. The new classification has soon arouse attention and been validated in some centers on the efficacy of differentiating adenomatous and hyperplastic polyps. However, most studies enrolled diminutive polyps less than 5mm and the efficacy of non-magnified NBI in differentiating type-2 and type-3 lesions has not been reported. To promote this simple classification, we design this multicenter study to evaluate the predictive validity and performance characteristics of the non-magnified NBI in diagnosing polyps during both image and real-time process.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with colorectal lesions during colonoscopy examination
  • Informed consent available

排除标准

  • Suspect of advanced colorectal cancer
  • History of colorectal surgery, familial adenomatous polyposis or inflammatory bowel disease
  • Poor bowel preparation
  • Patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc

结局指标

主要结局

Accuracy of NICE classification in histological prediction by gastroenterological fellows

时间窗: within two weeks after polypectomy

Diagnostic accuracy of gastroenterological fellows using non-magnified NBI according to NICE classification in histological prediction of polyps, compared with histologic examination

次要结局

  • Diagnostic accuracy of high-definition and magnifying NBI for type 2 and type 3 lesions.(two weeks after endoscopical or surgical resection)

研究者

发起方
Shanghai Jiao Tong University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhizheng Ge

Ren Ji Hospital, School of medicine, Shanghai Jiao Tong University

Shanghai Jiao Tong University School of Medicine

研究点 (1)

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