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临床试验/NCT03856957
NCT03856957已完成不适用

Serrated Lesions Detection With Endocuff-assisted Colonoscopy - A Randomized Controlled Trial

Hospital Beatriz Ângelo2 个研究点 分布在 1 个国家目标入组 257 人开始时间: 2018年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
257
试验地点
2
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 morbidity and mortality worldwide, especially in Western countries. CRC is currently considered a preventable disease and screening has been endorsed by several societies, since it has been shown that screening and surveillance are effective in reducing both CRC incidence and mortality. However, recently, concern has risen regarding colonoscopy effectiveness, especially in the right colon. The most accepted explanation for this effectiveness variability is attributed to sessile serrated lesions (SSL), which are more frequent in the proximal colon, more difficult to detect because of their flat morphology and associated with interval CRC, which is the occurrence of CRC after screening colonoscopy and before the next scheduled procedure. Several techniques are emerging to increase the sensitivity of colonoscopy for pre-cancerous lesions, especially adenomas. Recently an endoscopic cap, the Endocuff, was developed to improve adenoma detection. Several studies demonstrated improved adenoma detection with Endocuff-assisted colonoscopy when compared with conventional colonoscopy. Still, the available data for its' role in detecting SSL is very limited. The aim of this randomized controlled trial is to evaluate the effectiveness of Endocuff-assisted colonoscopy in detection of colorectal SSL.

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
None

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

入选标准

  • Outpatients undergoing elective colonoscopies

排除标准

  • Known polyposis syndromes
  • Personal colorectal cancer history
  • Previous colorectal surgery
  • Severe diverticulosis
  • Colonic stricture
  • Inflammatory bowel disease
  • Primary sclerosing cholangitis
  • Pregnancy and breastfeeding

结局指标

主要结局

Average number of serrated lesions ≥ 10 mm detected per colonoscopy

时间窗: immediate

Average number of serrated lesions ≥ 10 mm detected per colonoscopy

次要结局

  • Average number of adenomas detected per colonoscopy(immediate)
  • Cecal intubation rate(immediate)
  • Withdrawal time(immediate)
  • Incidence of procedure related adverse events(immediate)
  • Average number of serrated lesions < 10 mm detected per colonoscopy(immediate)
  • Serrated lesions detection rate(immediate)
  • Adenoma detection rate(immediate)
  • Adenocarcinoma detection rate(immediate)
  • Cecal incubation time(immediate)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandre Ferreira

Dr

Hospital Beatriz Ângelo

研究点 (2)

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