COmparison of White Light and Linked COlor Imaging for Detection of RIght COlon Polyps: A Multi Center Prospective Randomized Tandem Colonoscopy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 686
- 试验地点
- 2
- 主要终点
- the number of missed adenomas during the first exploration of the right colon
研究概览
简要总结
Comparison of the number of adenomas missed by the first exploration of the right colon by LCI (linked color imaging) or by white light during a colonoscopy, according to the order of randomization.
详细描述
All patients consecutively admitted for routine colonoscopy will be included in this prospective randomized crossover study. After randomization, a first exploration of the right colon will be performed in linked color imaging (LCI) or white light imaging (WLI) depending of the randomization. Every polyp will be resected as soon it will be detected. After this first examination, colon will be explored a second time with a light system different from the one used for the first exploration. If a polyp will be detected during the second exploration, it will be counted as a polyp missed by the first exploration method.
A- Inclusion criteria:
- Patient consecutively admitted to one of the endoscopy units for routine colonoscopy (screening, positive FIT, personal or family history of polyp or cancer, symptoms)
- Patient whose age is greater than or equal to 18 years and less than 90 years
- Score: ASA 1, ASA 2, ASA 3
- No participation in another clinical study
- Signed informed consent
Exclusion criteria:
History of recto-colic resection Inadequate preparation (none under Boston score <2) Patient referred for resection of a polyp in place, known IBD (inflammatory bowel disease) or known polyposis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient consecutively admitted for routine colonoscopy
排除标准
- •History of recto-colic resection
- •Inadequate preparation (none under Boston score <2)
- •Patient referred for resection of a known polyp
- •known Inflammatory Bowel Disease (IBD) or known polyposis
结局指标
主要结局
the number of missed adenomas during the first exploration of the right colon
时间窗: 1 day
Number of polyps diagnosed on the second exploration and not removed (because not diagnosed) during the first exploration
次要结局
- Serrated Polyp Detection Rate (SPDR)(1 day)
- The characteristics of the missed polyps(1 day)
- Adenoma Detection Rate (ADR)(1 day)
- Advanced Neoplasia Detection Rate (ANDR)(1 day)
- The factors influencing these missed polyp rates(1 day)
研究者
KARSENTI
Principal investigator
Société Française d'Endoscopie Digestive
