Impact of Chromoendoscopy on the Detection of Neoplasia in Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prevalence of dysplastic lesions by white light vs. chromoendoscopy
研究概览
简要总结
Long-standing ulcerative colitis is associated with an increased cancer risk. Chromoendoscopy with dye spraying can detect subtle abnormalities that are not visible with standard endoscopy. The purpose of this study is to determine if chromoendoscopy with fewer "targeted biopsies" can replace standard colonoscopy with multiple "random" biopsies.
详细描述
Patients with ulcerative colitis (UC) are at increased risk for colon cancer. Current guidelines recommend periodic surveillance colonoscopy in individuals who fulfill certain high-risk criteria. Endoscopists must perform a high number of biopsies (over 33 per patient) in order to increase the yield of such procedures. Chromoendoscopy (CE) has the ability to identify subtle lesions that are otherwise missed by standard endoscopy. Whether CE can replace standard colonoscopy in the surveillance of patients with UC is unknown.
Comparison: both standard biopsies and targeted biopsies will be obtained during colonoscopy from patients with UC who are candidates for surveillance colonoscopy. The yield of the two methods will be compared based on the number of biopsies required to identify one dysplastic (precancerous) lesion.
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
- •Ulcerative colitis, pancolitis > 8 years; left-sided > 15 years or
- •history of PSC or
- •history of previous dysplasia on colon biopsies or
- •family history of colon cancer in first degree relative
排除标准
- •any condition that precludes colonoscopy
- •expected survival less than 1 year
结局指标
主要结局
Prevalence of dysplastic lesions by white light vs. chromoendoscopy
时间窗: 12 months
次要结局
未报告次要终点
研究者
Michael Chiorean
Associate Professor of Medicine
Indiana University