Comparison of Surveillance Colonoscopy Techniques in Patients With IBD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Detection of neoplasia in the 3 cohorts - high definition colonoscopy, HD colonoscopy + iSCAN, HD colonoscopy + dye chromoendoscopy
研究概览
简要总结
We propose a randomized controlled study to determine the detection rates of neoplasia with high definition colonoscopy alone, high definition dye spraying chromoendoscopy or High definition iSCAN virtual chromoendoscopy in patients with long standing colitis (8 years from diagnosis except primary sclerosing cholangitis when surveillance starts at diagnosis) CD or UC.
We hypothesized that these novel endoscopic techniques using High definition colonoscopy with virtual chromoendoscopy -iScan 2 and 3 may be superior to high definition colonoscopy alone and similar to using dye spraying chromoendoscopy for detection of dysplasia and neoplasia in patients with long standing IBD.
We will aim to demonstrate if we can avoid dye spraying during the procedure and save expense and considerable time.
In addition, we can hope to produce evidence and inform the way in which we perform surveillance colonoscopy especially without large number of multiple random biopsies but only few targeted" smart and intelligent" biopsies using high definition colonoscopy with iSCAN technique as is already the European practice in several centres.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and histological diagnosis of UC or colonic CD-extensive or pancolitis.
- •UC -CD Disease duration 8 years from diagnosis UC-CD with associated primary sclerosing cholangitis from diagnosis Ulcerative Colitis Activity Index Mayo score 0-1 (inactive disease) Crohn's disease Activity Index - Harvey Bradshaw score <4 (dysplasia detection requires quiescent inflammatory bowel disease)
排除标准
- •Known intraepithelial neoplasia or colorectal cancer or other neoplasia Coagulopathy which may prevent biopsies Pregnancy Inability to obtain informed consent
结局指标
主要结局
Detection of neoplasia in the 3 cohorts - high definition colonoscopy, HD colonoscopy + iSCAN, HD colonoscopy + dye chromoendoscopy
时间窗: At the time of procedure
次要结局
未报告次要终点
研究者
Iacucci Marietta MD,PhD
Clinical Associate Professor
University of Calgary
