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临床试验/NCT02865382
NCT02865382Unknown不适用

Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy: A Randomized Trial

Yanqing Li1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2016年9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
adenoma detection rate

研究概览

简要总结

Optical Enhancement Technology might be superior to the conventional HD-WL in detecting colorectal adenomas

详细描述

Colorectal cancer is the third most common cancer in the world.Colonoscopy is the gold standard screening test for colorectal cancer.There are also emerging data to support that screening by colonoscopy reduces both the incidence and mortality of colorectal cancer.However,Colonoscopy could still miss colorectal adenomas and even cancer.The miss rate for colonic adenomas was reported to be ranging from 15 to 32% in tandem colonoscopy studies.The reasons for the miss rate may be technical(insufficient during excessively fast instrument withdrawal),but may also be the imaging method.Smaller lesions ,particularly flat ones ,may be missed as a result of their subtle appearance and limited contrast in relation to the surrounding mucosa.

Some image-enhanced modules were developed with an aim to improve colorectal polyp or adenoma detection.The widely available modules is the narrow band imaging(NBI).However,most studies failed to demonstrate any superiority of NBI system over white light colonoscopy in detecting colonic polyps.NBI provides dimmer images of the colonic mucosa ,which may limit its performance on polyp and adenoma detection.

Like NBI,OE technology is image-enhanced module,providing a more intense look at the vascular pattern morphology.Besides,OE technology provides an much brighter image compared to NBI.This may possibly increase polyp detection by enhancing visibility of the colonic mucosa with brighter image.The current study aims to tested whether OE technology would improve adenoma detection when compared with high-definition colonoscopy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • Patients were selected if they presented for diagnostic colonoscopy for a variety of indications(eg positive fecal occult blood test, abdominal pain, diarrhoea,post-polypectomy surveillance).

排除标准

  • Patients with prior resection of the proximal colon, advanced colonic cancer, inflammatory bowel disease, or polyposis syndrome.
  • The cecum could not be intubated.
  • Inadequate bowel preparation (Aronchick Bowel Preparation Scale score poor or inadequate).
  • Biopsies were not available.
  • Unable to provide informed consent.

结局指标

主要结局

adenoma detection rate

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
Yanqing Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yanqing Li

Professor

Shandong University

研究点 (1)

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