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临床试验/NCT04422548
NCT04422548Unknown不适用

Does AI-assisted Colonoscopy Improve Adenoma Detection in Screening Colonoscopy? A Multi-center Randomized Controlled

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 2,994 人开始时间: 2019年11月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
2,994
试验地点
1
主要终点
Per-patient ADR in each group

研究概览

简要总结

To date, there is a lack of large-scale randomized controlled study using AI assistance in the detection of polyps/adenoma in a screening population. The correlation of fecal occult blood test (FIT or FOBT) and the advantage of AI-assisted colonoscopy has not been investigated. There is also a lack of information of the benefit of AI-assisted colonoscopy in experienced colonoscopist versus trainee/resident.

详细描述

There are several studies showing that AI-assisted colonoscopy can help in identifying and characterizing polyps found on colonoscopy.

  • Byrne et al demonstrated that their AI model for real-time assessment of endoscopic video images of colorectal polyp can differentiate between hyperplastic diminutive polyps vs adenomatous polyps with sensitivity of 98% and specificity of 83% (Byrne et al. GUT 2019)
  • Urban et al designed and trained deep CNNs to detect polyps in archived video with a ROC curve of 0.991 and accuracy of 96.4%. The total number of polyps identified is significantly higher but mainly in the small (1-3mm and 4-6mm polyps) (Urban et al. Gastroenterol 2018)
  • Wang et al conducted an open, non-blinded trial consecutive patients (n=1058) prospectively randomized to undergo diagnostic colonoscopy with or without AI assistance. They found that AI system increased ADR from 20.3% to 29.1% and the mean number of adenomas per patients from 0.31 to 0.53. This was due to a higher number of diminutive polyps found while there was no statistic difference in larger adenoma. (Wang et al. GUT 2019). In this study, they excluded patients with IBD, CRC and colorectal surgery. The patients presented with symptoms to hospital for investigation.

To date, there is a lack of large-scale randomized controlled study using AI assistance in the detection of polyps/adenoma in a screening population. The correlation of fecal occult blood test (FIT or FOBT) and the advantage of AI-assisted colonoscopy has not been investigated. There is also a lack of information of the benefit of AI-assisted colonoscopy in experienced colonoscopist versus trainee/resident.

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
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients receiving colonoscopy screening
  • •Patients aged 45-75 years
  • •Both patients who have or have not done a FIT test and both FIT +ve and FIT -ve subjects

排除标准

  • •Patients who have symptom(s) suggestive of colorectal diseases
  • •Patients who have a history of inflammatory bowel disease, colorectal cancer or polyposis syndrome (anaemia, bloody stool, tenesmus and obstructive symptoms)
  • •Patients who had colonoscopy or other investigation of colon and rectum in the past 10 years
  • •Patients who had surgery for colorectal diseases
  • •Patients who cannot tolerate bowel preparation or have suboptimal bowel preparations (Boston Bowel Preparation Scale)
  • •Cannot reach caecum
  • •Patients who are incompetent in giving informed consent

研究组 & 干预措施

AI-assisted Group

Active Comparator

干预措施: AI-assisted Colonoscopy (Procedure)

Standard

Active Comparator

干预措施: Standard Colonoscopy (Procedure)

结局指标

主要结局

Per-patient ADR in each group

时间窗: 12 months

For the AI-Assisted group, it is defined as the number of patients with at least 1 adenoma identified in the colon divided by the total number of patients in the AI-Assisted group.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph JY SUNG

Professor

Chinese University of Hong Kong

研究点 (1)

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