The Clinical Value of Chromoendoscopy as Surveillance Strategy for Dysplasia Detection in Ulcerative Colitis: an Observational Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.
研究概览
简要总结
A recent multicentre randomised controlled trial compared autofluorescence imaging (AFI) with CE for dysplasia detection in colonoscopy surveillance of patients with longstanding UC (FIND-UC). In this study, CE detected significantly more dysplastic lesions per patient compared with AFI. It is unclear whether this increased dysplasia detection also translates to a reduction of dysplasia at follow-up colonoscopy. The aim of this pre-specified study is therefore to prospectively determine whether there is a difference in dysplasia detection at follow-up colonoscopy between UC patients who were randomized to AFI or CE at index colonoscopy for the FIND-UC trial.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.
时间窗: during surveillance colonoscopy
the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.
次要结局
- The proportion of patients in which at least one histological proven neoplastic lesion was detected(during surveillance colonoscopy)
- The proportion of patients in which at least one histological proven sessile serrated lesion was detected(during surveillance colonoscopy)
- The mean number of histological proven neoplastic lesions per patient(during surveillance colonoscopy)
- The mean number of histological proven sessile serrated lesions per patient(during surveillance colonoscopy)
- Description of dysplasia detected at follow-up colonoscopy (colonic segment, location with respect to a resection scar if visible), or in the resection specimen after proctocolectomy. The proportion of lesions defined as new/missed and recurrent lesion(during surveillance colonoscopy)
研究者
Prof. Evelien Dekker, MD, PhD
Clinical Professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)