Improving Colorectal Cancer Screening: Using Narrow Band Imaging for Colonic Sessile Serrated Lesions
试验速览
- 阶段
- 不适用
- 入组人数
- 987
- 试验地点
- 3
- 主要终点
- average number of serrated lesions ≥10 mm detected per colonoscopy
研究概览
简要总结
Colorectal cancer (CRC) is a leading cause of cancer death and its' incidence is rising in most European countries. Colonoscopy has been shown to reduce CRC incidence, however its effectiveness depends on the sensitivity to detect pre-malignant lesions.
Our aim is to evaluate narrow band imaging (NBI) during colonoscopy and serum miRNAs as novel tools for the early detection of colonic sessile serrated lesions (SSL). The investigators will perform a multicenter-randomized-controlled-trial to study the role of NBI in SSL detection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for elective colonoscopies
排除标准
- •known polyposis syndromes
- •primary sclerosing cholangitis
- •inflammatory bowel disease
- •personal colorectal cancer history
研究组 & 干预措施
Narrow band imaging withdrawal
colonoscope withdrawal and mucosal inspection performed under narrow band imaging
干预措施: narrow band imaging withdrawal (Device)
white light withdrawal
colonoscope withdrawal and mucosal inspection performed under white light imaging
干预措施: white light withdrawal (Device)
结局指标
主要结局
average number of serrated lesions ≥10 mm detected per colonoscopy
时间窗: immediate
次要结局
- Serrated lesions <10 mm detected per colonoscopy(immediate)
- Serrated class lesions detection rate(immediate)
- Adenomas detected per colonoscopy(immediate)
- SSL detection rate(immediate)
- Adenoma detection rate(immediate)
- Advanced (malignant) adenocarcinoma detection rate(immediate)
- Incidence of procedure related adverse events(immediate)
研究者
Alexandre Ferreira
Gastroenterologist
Hospital Beatriz Ângelo