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临床试验/NCT04112563
NCT04112563已完成不适用

COmparison of White Light and Linked COlor Imaging for Detection of RIght COlon Polyps: A Multi Center Prospective Randomized Tandem Colonoscopy Study

Société Française d'Endoscopie Digestive2 个研究点 分布在 1 个国家目标入组 686 人开始时间: 2020年1月1日最近更新:
适应症

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:

  1. Patient consecutively admitted to one of the endoscopy units for routine colonoscopy (screening, positive FIT, personal or family history of polyp or cancer, symptoms)
  2. Patient whose age is greater than or equal to 18 years and less than 90 years
  3. Score: ASA 1, ASA 2, ASA 3
  4. No participation in another clinical study
  5. 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

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

发起方
Société Française d'Endoscopie Digestive
申办方类型
Other
责任方
Principal Investigator
主要研究者

KARSENTI

Principal investigator

Société Française d'Endoscopie Digestive

研究点 (2)

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