Assessment of Efficacy of ENDO-AID Assisted Colonoscopy in Adenoma Detection: a Single Centre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Adenoma missed rate
研究概览
简要总结
This study hypothesizes that more adenomas will be detected using the ENDO-AID assisted Colonoscopy compared to conventional colonoscopy.
A single-centre, randomized, same-day, back-to-back tandem colonoscopy trial comparing Adenoma Missed Rate and Adenoma Detection Rate in ENDO-AID assisted colonoscopy and conventional colonoscopy.
详细描述
Colorectal cancer is the third common cancer in the world and the commonest cancer in Hong Kong. Most sporadic colorectal cancers arise from benign polyps via adenoma-carcinoma sequence or the serrated polyp-carcinoma sequence. There are reports of unexpectedly high risk of interval carcinomas, as high as up to 9%, raising concerns about the effectiveness of colonoscopy in preventing colorectal cancers. Different techniques have been described to improve the area of mucosa visualised but lesions may still be missed due to failure of identification by the endoscopist.
Computer Aided diagnosis (CAD) assisted colonoscopy is becoming increasingly popular to address human error. Deep learning technology has surpassed human learning and advancement in technology now allows real-time Artificial Intelligence to assist colonoscopists in polyp 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18years or above
- •Referred to endoscopy unit for diagnostic or surveillance colonoscopy
排除标准
- •Familial history of Familial adenomatous polyposis / Hereditary non-polyposis colorectal cancer
- •Known history of inflammatory bowel disease
- •Known colitis or suspicion of colitis (inflammatory bowel disease, diverticulitis, infective colitis)
- •Emergency endoscopy of any nature (eg gastrointestinal bleeding, colonic decompression)
- •Previous incomplete colonoscopy (not including insufficient preparation) / difficult colonoscopy
- •Patients referred for a therapeutic procedure or assessment of a known non-resected lesion
- •Patients with known palliative colorectal malignancy
- •Patient with coagulopathy
- •Patient with colostomy
- •Patient with multiple co-morbidities (American Society of Anaesthesiologist >3)
- •Inability to give informed consent
结局指标
主要结局
Adenoma missed rate
时间窗: End of study, about 1 year
To compare the adenoma missed rate (AMR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy. AMR is defined as the number of adenomas detected in the second pass colonoscopy divided by the total number of adenomas detected in both passes for the same patients.
次要结局
- Patient missed rate(End of study, about 1 year)
- Serious Adverse Events(At 30 days)
- Adenoma detection rate(End of study, about 1 year)
- Number of polyps removed(End of study, about 1 year)
- Baseline Parameters(End of study, about 1 year)
- Polyp missed rate(End of study, about 1 year)
- Number of CAD assisted abnormality(End of study, about 1 year)
研究者
Kaori Futaba
Assistant Professor
Chinese University of Hong Kong