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临床试验/NCT05754229
NCT05754229已完成不适用

Accuracy of Real Time Characterization in Artificial Intelligence-assisted Colonoscopy - A Prospective Quality Assurance Study

Ismail Gögenur8 个研究点 分布在 1 个国家目标入组 395 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
395
试验地点
8
主要终点
True negative findings: Non-adenomas (histopathologically verified) characterized as non-adenomas by the AI system

研究概览

简要总结

The goal of this substudy is to investigate the accuracy of a computer-aided polyp characterization (CADx) system. The main question[s] it aims to answer are:

• How high is the specificity of the AI system when characterizing colorectal polyps

Participants will receive a standard colonoscopy, assisted by the artificial intelligence (AI) assisted system GI Genius.

Researchers will compare the AI system´s characterization with the histopathology to see how accurate the system is.

详细描述

Colorectal cancer (CRC) is the third most common cancer, and the second most common cause of cancer-related death worldwide. CRC screening is used for detection and removal of precancerous lesions before they develop into cancer. Colonoscopy is regarded being superior to other screening tests, and is therefore used as the golden standard.

Screening colonoscopy is associated with a reduced risk of CRC-related death. Since it is not possible for an endoscopist to determine the histopathology of the polyp with certainty during a colonoscopy, detected pre-malignant lesions should be removed and sent for histological examination. Multiple studies have shown that there is a strong association between findings at the baseline screening colonoscopy and rate of serious lesions at the follow up colonoscopy. Risk factors for adenoma, advanced adenoma and cancer at follow-up colonoscopy are multiplicity, size, villousness, and high degree dysplasia of the adenomas at the baseline screening colonoscopy.

Within the last few years there have been published several randomized controlled trials (RCT) investigating the efficacy of real time computer-aided detection. Studies have shown that AI contributes to a significantly higher adenoma detection rate (ADR), compared colonoscopies without assistance of an AI system.There have been concerns about prolonged colonoscopy time, and increased workload if implementing the AI-system, since the increased detection of small polyps may lead to unnecessary polypectomy.

With the development of computer-aided polyp characterization (CADx) systems, it is possible to use AI for decision support and not only for detection. There is no evidence yet that the CADx system increases the sensitivity for small neoplastic polyps when used by non-expert endoscopists (accredited for standard colonoscopy), but it may improve the clinicians confidence, and increase the specificity for optical diagnosis (Barua et al).

Diminutive polyps (1-5 mm) in the rectosigmoid colon can be left in situ when diagnosed with high confidence with a sensitivity of at least 90% and a specificity of at least 80%. To implement the resect-and-discard strategy, a sensitivity of at least 80% is acceptable. This is recommended by the European Society of Gastrointestinal Endoscopy (ESGE) as a strategy to decrease the unnecessary removal of small polyps with a negligible risk of harbouring cancer. Although the resect-and-discard strategy is assessed to be a safe and cost-effective method, it is important to be cautious with lesions in the right colon due to their malignant potential.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Referred for screening colonoscopy due to a positive faecal immunochemical test (FIT) or for
  • Diagnostic colonoscopy due to symptoms/signs or
  • Post-polypectomy surveillance colonoscopy (only patients who had all detected polyps removed in the previous colonoscopy)

排除标准

  • Referral for removal of previous detected polyps
  • Emergency colonoscopy
  • Control colonoscopy due to inflammatory bowel disease (IBD)

结局指标

主要结局

True negative findings: Non-adenomas (histopathologically verified) characterized as non-adenomas by the AI system

时间窗: 5 Months

Data from the AI system will be compared with the histopathological data for each removed polyp

False negative findings: Adenomas (histopathologically verified) characterized as non-adenomas by the AI system

时间窗: 5 Months

Data from the AI system will be compared with the histopathological data for each removed polyp

True positive findings: Adenomas (histopathologically verified) characterized as adenomas by the AI system

时间窗: 5 Months

Data from the AI system will be compared with the histopathological data for each removed polyp

False positive findings: Non-adenomas (histopathologically verified) characterized as adenomas by the AI system

时间窗: 5 Months

Data from the AI system will be compared with the histopathological data for each removed polyp

次要结局

未报告次要终点

研究者

发起方
Ismail Gögenur
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ismail Gögenur

Professor, DMSc

Zealand University Hospital

研究点 (8)

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