Combination of Artificial Intelligence (ENDOAID) and Mucosal Exposure Device (ENDOCUFF) to Enhance Colorectal Neoplasia Detection: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,726
- 试验地点
- 2
- 主要终点
- ADR
研究概览
简要总结
The investigators hypothesize that the combined use of CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) would improve the adenoma detection rate when compared to CADe system alone.
详细描述
High polyp miss rates were reported in standard colonoscopies. As a result, a significant proportion of interval CRC was attributed to the missed lesions during index colonoscopy. Risk factors of missed lesions included proximal location, serrate or flat morphology, poor bowel preparation, short withdrawal time and endoscopist experience.
To overcome this pitfall, various methods were developed to improve adenoma detection rate (ADR), including distal attachment devices. Among the mucosal exposure devices, Endocuff Vision® was shown to be superior than conventional colonoscopies.
Recently, artificial intelligence and automatic computer-aided polyp detection (CADe) systems have developed rapidly and revolutionized the medical field. Nevertheless, there was a potential limitation of 'blind spot' if the endoscopist failed to expose the colonic mucosa adequately leading to missed lesions. To date, no available data or ongoing clinical trial was reported regarding the combined use of CADe and mucosal exposure devices. It may enhance the performance of CADe and provide a novel definitive solution to this unaddressed yet important clinical problem.
In this prospective parallel randomized controlled trial, we aim to evaluate the impact of combined use of a new CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) on colorectal neoplasia detection.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 45-85 years old;
- •They require elective colonoscopy for colorectal cancer screening, polyp surveillance, or investigation of symptoms such as anemia or altered bowel habit;
- •Written informed consent obtained.
排除标准
- •Contraindication to colonoscopy (e.g. intestinal obstruction or perforation)
- •Contraindication or conditions precluding polyp resection (e.g. active gastrointestinal bleeding, uninterrupted anticoagulation or dual antiplatelets)
- •Staged procedure for polypectomy or biopsy of known unresected lesions
- •Previous surgical resection of colon
- •Personal history of colorectal cancer
- •Personal history of familial polyposis syndrome
- •Personal history of inflammatory bowel disease
- •Advanced comorbid conditions (defined as American Society of Anesthesiologists grade 4 or above)
- •Unable to obtain informed consent
研究组 & 干预措施
ENDOAID
CADe system will be used during withdrawal phase of colonoscopy.
ENDOAID with ENDOCUFF
CADe system and mucosal exposure device (ENDOCUFF) will be used during withdrawal phase of colonoscopy.
干预措施: ENDOCUFF (Device)
结局指标
主要结局
ADR
时间窗: During the colonoscopy
adenoma detection rate
次要结局
- ADR for adenomas of different colonic segments(During the colonoscopy)
- Non-neoplastic resection rate(During the colonoscopy)
- False positive rate(During the colonoscopy)
- Withdrawal time(During the colonoscopy)
- Total procedural time(During the colonoscopy)
- Caecal intubation time(During the colonoscopy)
- ADR for adenomas of different sizes(During the colonoscopy)
- Mean number of adenomas per colonoscopy(During the colonoscopy)
- Sessile serrated lesion (SSL) detection rate(During the colonoscopy)
- Advanced adenoma detection rate(During the colonoscopy)
- Polyp detection rate(During the colonoscopy)
研究者
Louis Ho Shing Lau
Assistant Professor
Chinese University of Hong Kong