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临床试验/NCT06678477
NCT06678477招募中不适用

Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group: a Multi-center, Randomized Controlled Trial

National Taiwan University Hospital3 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
3
主要终点
Adenoma detection rate

研究概览

简要总结

Background:

Adenoma detection rate is one of the most quality indicator: 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 mortality1,2. 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 CRC3,4. A recent study further demonstrated the improvement of ADR could reduce subsequent risk of CRC5.

Equipment and technique to improve ADR: 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)6. Nowadays, several colonoscopy technologies had been developed to enhance the detection of colorectal adenoma such as using digital or dye-spray chromoendoscopy7 or add-on device such as Cap/Endocuff/third eye/FUSE-assisted endoscopy8. Among them, some had showed the potential to enhance the detection of non-polypoid lesion, for example, the next-generation NBI9 or iSCAN10.

Application of 3D endoscopy on GI disease: 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 tumors11 and shortened the procedure time during performing gastric endoscopic submucosal dissection (ESD)12. However, few is known that whether 3D colonoscopy could enhance the ADR, especially for non-polypoid lesion detection, during colonoscopy examination.

Positive fecal immunochemical test(FIT) group Among subjects who receive colonoscopy examination, higher advanced adenoma or invasive caners were found in FIT positive group. However, still about half of positive FIT subjects who received colonoscopy exam, have negative colonoscopy result. Non polypoid lesions could be overlooked during the colonoscopy. Therefore, we tried to use this prospective, multicenter, randomized control study to demonstrate the efficacy of 3D colonoscopy on adenoma detection in comparison with conventional 2D colonoscopy in this kind of high risk group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • •Subjects who are 40 years of older
  • •Subjects who have positive fecal immunochemical test

排除标准

  • •Contraindication for colonoscopy
  • •Subjects with familiar or hereditary polyposis
  • •Subjects with history of colectomy
  • •Inadequate bowel cleansing level
  • •Subjects with inflammatory bowel disease

研究组 & 干预措施

3D colonoscopy

Experimental

Use 3D machine to generate the 3D image

干预措施: 3D device (Device)

2D colonoscopy

No Intervention

Traditional colonoscopy

结局指标

主要结局

Adenoma detection rate

时间窗: 30 minutes

次要结局

  • SSLDR(30 minutes)
  • Flat-ADR(30 minutes)
  • Proximal ADR(30 minutes)
  • AADR(30 minutes)
  • Polyp detection rate(30 minutes)
  • adenoma number per colonoscopy,(30 minutes)
  • polyp number per colonoscopy,(30 minutes)

研究者

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

Statistical Center, NTUHCTC

Dr.

National Taiwan University Hospital

研究点 (3)

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