跳至主要内容
临床试验/NCT02138318
NCT02138318已完成不适用

Randomized Controlled Trial of High Definition White Light Endoscopy Versus Chromoendoscopy for Dysplasia Detection in Ulcerative Colitis Surveillance

The Leeds Teaching Hospitals NHS Trust2 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2012年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
152
试验地点
2
主要终点
number of lesions

研究概览

简要总结

Patients with ulcerative colitis (UC) have an increased risk for colorectal cancer (CRC) compared to the general population. Regular screening by colonoscopy is an internationally recommended cancer prevention strategy. Random sampling of the mucosa throughout the colon has been the mainstay of conventional surveillance practice to detect abnormalities, known as dysplasia which can progress to CRC. This requires multiple biopsies, to be taken and processed, a practice which is is tedious, expensive, time consuming and has a low pickup rate. Dysplasia in UC is typically flat and patchy and can be easily overlooked with standard conventional white light colonoscopy (WLC).

Detection can be improved by the application of dyes which highlight more subtle abnormalities. This practice, known as chromoendoscopy (CE) is better than WLC at dysplasia detection but more time consuming for the patient and cannot guarantee that the whole colon is covered. CE has only been compared in clinical trials with standard definition endoscopy rather than the recently available high definition endoscopes with better resolution and picture. High definition (HD) endoscopy uses a high definition onitor and a high resolution CCD (charge coupled device) providing much better images than standard video endoscopy. HD colonoscopy promises therefore to provide an alternative to CE in UC surveillance without the need for the extra time and experience required for dye spraying for both endoscopists and nursing staff.

The investigators plan to do a randomized trial to assess HD colonoscopy alone compared to chromoendoscopy (with HD colonoscopies) for dysplasia detection during surveillance for ulcerative colitis. There have been no trials comparing these two modalities and the investigators hope to provide evidence that the additional benefit of CE over HD colonoscopy would be marginal and therefore CE would be reserved for procedures using standard definition scopes.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with longstanding (more than 10 years), extensive (extending proximal to the splenic flexure) colitis attending for surveillance colonoscopy.
  • Patients over 18 years of age

排除标准

  • Pregnancy
  • Unwilling or unable to give informed consent
  • Severe active colitis (as assessed by the endoscopist)

结局指标

主要结局

number of lesions

时间窗: Once annually at routine clinical assessment

The number of lesions with at least low grade dysplasia detected by targeted biopsy to be compared between the two groups by chisquared test.

次要结局

未报告次要终点

研究者

发起方
The Leeds Teaching Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

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