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临床试验/NCT07076966
NCT07076966招募中不适用

Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Surveillance Colonoscopy: 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 500 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
500
试验地点
3
主要终点
Adenoma detection rate

研究概览

简要总结

There is substantial evidence confirming that identifying and removing colorectal adenomas during colonoscopy helps prevent the development of colorectal cancer. Among the quality indicators for colonoscopy, adenoma detection rate (ADR) is the most important, as it is closely related to the patient's future risk of colorectal cancer. Recent studies have further demonstrated that improving ADR can reduce future mortality from colorectal cancer. Notably, non-polypoid lesions (such as flat or depressed lesions) are more likely to be missed during traditional colonoscopy, making these lesions a leading cause of post-colonoscopy interval colorectal cancer.

In a prospective trial conducted by our team comparing the ADR of 3D colonoscopy with standard 2D colonoscopy, we found that 3D colonoscopy significantly improved overall ADR and the detection rate of non-polypoid adenomas.

According to current international guidelines, after an index colonoscopy, patients are recommended to undergo surveillance colonoscopy 1 to 10 years later, depending on their findings at index colonoscopy. Since these patients represent the majority in clinical practice, increasing the ADR during surveillance colonoscopy not only allows for more precise recommendations for the timing of the next colonoscopy but also effectively reduces the risk of post-colonoscopy colorectal cancer (PCCRC).

Therefore, this multicenter, prospective, randomized trial aims to compare the clinical performance of 3D colonoscopy and standard 2D colonoscopy in the context of surveillance colonoscopy.

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 receive colonoscopy and polypectomy more the 1 year
  • •Subjects who need surveillance colonoscopy

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

2D colonoscopy

No Intervention

3D colonoscopy

Experimental

干预措施: 3D device (Device)

结局指标

主要结局

Adenoma detection rate

时间窗: 30 minutes

次要结局

  • Flat-ADR(30 minutes)
  • Proximal ADR(30 minutes)
  • Distal ADR(30 minutes)
  • SSLDR(30 minutes)
  • AADR(30 minutes)
  • Detection of of adenoma with various size(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

Attending physician, Department of Internal Medicine

National Taiwan University Hospital

研究点 (3)

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