Adenoma Detection Rate Using Endocuff Vision in China
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 1,200
- 试验地点
- 5
- 主要终点
- Adenoma detection rate, ADR
研究概览
简要总结
The primary aim of this study is
- to explore the usefulness of Endocuff Vision in colonoscopy on adenoma detection rate (ADR).
Other aims include to explore the data below when Endocuff Vision is used.
Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure, MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT
详细描述
Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and remove them. Removing adenomas is known to reduce the chances of a person developing colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot of researches into how to improve "adenoma detection rates".
A new device, called the Endocuff Vision has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy will be invited in 5 centres, recruiting a total of 1200 participants.
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
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients referred for screening, surveillance, or diagnostic colonoscopy
- •All patients must be able to give informed consent
排除标准
- •Patients with any absolute contraindications to colonoscopy
- •Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
- •Patients with known colon cancer or polyposis syndromes
- •Patients with known colonic strictures
- •Patients with known severe diverticular segments (that is likely to impede colonoscope passage)
- •Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
- •Patients lacking capacity to give informed consent
- •Pregnancy
- •Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure.
- •Patients who are attending for a therapeutic procedure or assessment of a known lesion
结局指标
主要结局
Adenoma detection rate, ADR
时间窗: At the end of the procedure, up to 1 hour.
ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.
次要结局
- Polyp detection rate, PDR(At the end of the procedure, up to 1 hour.)
研究者
En-Da Yu
Director of Department of Colorectal Surgery and Vice Director of GI Endoscopy
Changhai Hospital