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临床试验/NCT05153746
NCT05153746招募中不适用

Comparison of Adenoma Detection Rate Between Conventional Colonoscopy and 3D Colonoscopy: a Randomized Controlled Trial

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
Adenoma detection rate

研究概览

简要总结

Adenoma detection rate (ADR) has been the most important quality indicator on colonoscopy because ADR was reversely related with CRC incidence and mortality. Several image enhanced technologies, such as narrow-band imaging (NBI) or linked colour imaging (LCI) had been proved to have ability to increase the ADR. 3D techonology, however, has not been validated on colonoscopy performance. Therefore, current study was to compare the ADR between new 3D colonoscopy and conventional 2D colonoscopy.

详细描述

An accumulating body of evidence has shown that detection and resection of pre-cancerous adenoma by colonoscopy could effectively prevent colorectal cancer (CRC) and its related mortality. Among various colonoscopy quality indicators, such as cecal intubation rate, withdrawal time, and adenoma detection rate (ADR), ADR is the most important one and most closely associated with the subsequent risk of CRC. A recent study further demonstrated the improvement of ADR could reduce subsequent risk of CRC.

To be noted, among all colorectal neoplasm, non-polypoid lesions, such as flat or depressed lesions, carries higher likelihood to be overlooked during conventional colonoscopy and these overlooked lesions were the main etiology of post-colonoscopy colorectal cancer (PCCRC). Nowadays, several colonoscopy technologies had been developed to enhance the detection of colorectal adenoma such as using digital or dye-spray chromoendoscopy or add-on device such as Cap-assisted endoscopy. Among them, some had showed the potential to enhance the detection of non-polypoid lesion, for example, the next-generation NBI or iSCAN.

3D endoscopy is a new technology that using image processing technique to offer more information on tissue depth in comparison with conventional 2D endoscopy. The utility of 3D endoscopy on GI tract was mainly from upper GI tract and it was proved to enhance the diagnostic accuracy on superficial gastric tumors and shortened the procedure time during performing gastric endoscopic submucosal dissection(ESD). However, few is known that whether 3D colonoscopy could enhance the adenoma detection, especially for non-polypoid lesion detection, during colonoscopy examination. Therefore, this prospective, randomized control study is aim to demonstrate the efficacy of 3D colonoscopy on adenoma detection in comparison with conventional 2D colonoscopy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 40 or above
  • Indication for colonoscopy, including screening, surveillance, symptomatic, etc

排除标准

  • Poor and inadequate bowel preparation
  • Incomplete study because of obstructive lesion, including cancer, stenosis, etc.
  • Failure of cecal intubation, difficult insertion
  • Inflammatory bowel disease
  • Hereditary polyposis, (FAP, Lynch syndrome, hyperplastic polyposis, etc.)

结局指标

主要结局

Adenoma detection rate

时间窗: 1 week

The number of subjects with at least one adenomatous polyp found during the colonoscopy

次要结局

  • Sessile serrated adenoma detection rate(1 week)
  • Proximal adenoma detection rate(1 weeks)
  • Adenoma per colonoscopy (APC)(1 week)
  • Flat adenoma detection rate(1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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