Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Surveillance Colonoscopy: A Multi-center, Randomized Controlled Trial
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
3D colonoscopy
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
Statistical Center, NTUHCTC
Attending physician, Department of Internal Medicine
National Taiwan University Hospital
