Clinical Efficacy Evaluation of a Computer-aided Colonoscopy as Compared With the Standard Colonoscopy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Adenoma detection rate
研究概览
简要总结
Colonoscopy is clinically used as the gold standard for detection of colorectal cancer (CRC) and removal of adenomatous polyps of the colon and rectum. Evidence has shown that CRC could be prevented by colonoscopic removal of adenomatous polyps. Despite the success of colonoscopy in reducing cancer-related deaths, there exists a disappointing level of adenomas missed at colonoscopy. In recent years, emerging artificial intelligence (AI) and computer-aided detection (CADe) technology has been shown to improve ADR. Based on a meta-analysis, ADR was demonstrated to be significantly higher in the CADe groups than in the standard colonoscopy groups, representing a relative risk of 25.2%.
In this study, performance of colonoscopy with or without aid of CADe will be compared in terms of quality indicators. The adenoma detection rate (ADR), which is the proportion of average-risk patients undergoing screening colonoscopy in whom an adenoma is found, is regarded as a robust measure of colonoscopy performance quality that correlates with subsequent cancer risk. Thus, ADR is taken as the primary outcome of this study. The target population includes individuals who are undergoing screening, diagnostic, or surveillance colonoscopy.
详细描述
This multiple-site study aims to evaluate whether a computer-aided detection (CADe) device can assist in adenoma detection rate (ADR) when compared with the current standard-of-care procedure. The subject CADe device used in this study contains an artificial intelligence/machine learning (AI/ML) advanced algorithm to aid the endoscopists in detection of colonic mucosal lesions and the detected polyps will be highlighted to the endoscopists during the real-time colonoscopy procedures. This study plans to enroll subjects aged ≥ 40 years and < 80 years, who are scheduled for screening or diagnostic colonoscopy for colorectal cancer (CRC) or surveillance colonoscopy for post-polypectomy follow-up. After being evaluated with the inclusion and exclusion criteria, eligible subjects will be randomized in a 1:1 ratio to receive either the computer-aided colonoscopy (CC) or the standard colonoscopy(SC). Randomization will be stratified by gender, age, and colonoscopy indication (screening, diagnostic, or surveillance) of subjects. The resected polyps will be submitted for histologic examination by one expert pathologist at each site. If any uncertainty or doubt exists, an expert in gastrointestinal pathology will serve as the adjudicator to perform a second review and make the final decision. All of the pathologists (including the final adjudicator) who will perform the histopathologic examinations and produce the pathology assessment will be blinded to the assigned study arm of the specimens. The pathology reports of the subjects will be kept securely at each site as the source data.
The primary endpoint is the ADR of the CC as compared with that of the SC. The ADR is defined as the percentage of subjects undergoing a complete colonoscopy, who have at least one histologically confirmed adenoma detected and removed. In addition, the following secondary endpoints will also be evaluated, including: Polyp detection rate (PDR), Adenomas per colonoscopy (APC), Polyps per colonoscopy (PPC), Non-neoplastic polypectomy rate (NNPR), Non-neoplastic polypectomy (NNP), Sessile serrated lesions per colonoscopy (SPC), Advanced adenomas per colonoscopy (AAPC), and withdrawal time.
Signed written informed consent forms will be obtained from all participating subjects before enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The subject and the pathologist who performs the histopathological review will be blinded to the received procedure, while the operator for colonoscopy will not be blinded to the study arm assigned to the subject.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who have given signed informed consent form
- •Informed consensus has been obtained that endoscopic resection should be performed if a lesion is found
- •Subjects who are scheduled for screening or diagnostic colonoscopy for colorectal cancer (CRC) or surveillance colonoscopy for post-polypectomy follow-up
排除标准
- •Subjects with any of the following prior history or current conditions:
- •Contraindications to colonoscopy
- •Inflammatory bowel disease (IBD)
- •Colorectal cancer (CRC)
- •Familial adenomatous polyposis (FAP)
- •Colonic stenosis
- •Severe organ failure (cirrhosis of Child C, heart failure of ACC / AHA stage D)
- •Active gastrointestinal (GI) Bleeding
- •Prior colorectal surgery, including colonic or rectal resection (except for appendectomy, surgery on the anus, and polypectomy)
- •Undergo colonoscopy within 3 years
- •Subjects with any of the following conditions per the investigator's judgement:
- •High suspicion of IBD, CRC, and FAP.
- •High risk of bleeding after endoscopic treatment, and difficult management of anticoagulation or antiplatelet medication.
结局指标
主要结局
Adenoma detection rate
时间窗: 1 week (after the colonoscopy procedure, when pathology report is released)
The percentage of subjects undergoing a complete colonoscopy, who have at least one histologically confirmed adenoma detected and removed.
次要结局
- Adenomas per colonoscopy (APC)(1 week (after the colonoscopy procedure, when pathology report is released))
- Non-neoplastic polypectomy rate (NNPR)(1 week (after the colonoscopy procedure, when pathology report is released))
- Withdrawal time(1 day(right after the colonoscopy procedure))
- Polyp detection rate (PDR)(1 day(right after the colonoscopy procedure))
- Advanced adenomas per colonoscopy (AAPC)(1 week (after the colonoscopy procedure, when pathology report is released))
- Polyps per colonoscopy (PPC)(1 day(right after the colonoscopy procedure))
- Sessile serrated lesions per colonoscopy (SPC)(1 week (after the colonoscopy procedure, when pathology report is released))