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临床试验/NCT04111601
NCT04111601已完成不适用

BLI Based Adenoma Surveillance Strategy: BLAST Study

Portsmouth Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 217 人开始时间: 2019年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
217
试验地点
1
主要终点
Percentage of adenomas correctly identified with BLI

研究概览

简要总结

Bowel cancer is the third most common cancer in the UK. It develops through smaller growths in the bowel called polyps. Early recognition and removal of these polyps result in prevention of developing bowel cancer in an individual. However, not all polyps will lead to cancer, certain polyps are just growths of normal tissue and can be left in the bowel. We therefore need to know which polyps to remove and which ones to leave. One way of doing this is to have a better look at these polyps. This can be done by new technologies. One of them is called Blue Light Imaging (BLI). This is a new light source at the end of the camera which is activated by the push of a button. It will help us in looking at these polyps more closely.

This helps us decide which polyps to remove and which ones are safe to leave as there is always a small risk in removing a polyp. It would also give us a better idea as to when to repeat the camera test if necessary (endoscopic surveillance). By reducing the number of polyps resected and sent to the pathology labs for diagnosis, the work load on the pathology department is also reduced and in the process, providing cost savings to the Trust, The study aims to see if using Blue Light during endoscopy helps us to identify and characterize small polyps better

详细描述

Advanced endoscopic imaging can facilitate the characterisation of neoplastic and non-neoplastic polyps. Accurate identification of small non-neoplastic polyps (e.g. rectosigmoid hyperplastic polyps) that do not harbour malignant potential can lead to future implementation of a 'resect and discard' or 'diagnose and leave' strategy. However, there is insufficient evidence that endoscopists are able to attain high enough levels of optical diagnostic performance in-vivo in order to implement this strategy safely. Blue Light Imaging (BLI) is a new enhanced imaging technology that enhances mucosal surface and vessel patterns. A specific BLI classification was recently developed to enable better characterisation of colorectal polyps (BLI Adenoma Serrated International Classification - BASIC). The use of this technology with the appropriate classification to enhance its performance has not yet been tested in clinical settings of polyp surveillance and screening colonoscopy amongst general endoscopists.

BLAST is a multicentre prospective observational study which will compare BLI optical diagnosis with histological assessment (as a reference standard) for patients with small polyps (<10mm) identified at colonoscopy.

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

入选标准

  • > 18 years of age Able to provide informed consent

排除标准

  • History of polyposis syndrome History of Inflammatory bowel disease History of poor bowel prep

结局指标

主要结局

Percentage of adenomas correctly identified with BLI

时间窗: 12 months

Accuracy of BLI in optical diagnosis of small colorectal polyps

次要结局

  • Amount of money saved in GBP ( Cost savings)(12 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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