Implementation of Optical Diagnosis of Diminutive Colorectal Polyps in Real Life Clinical Practice: DISCARD3 Study (Incorporating AI-DETECT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 614
- 试验地点
- 1
- 主要终点
- Proportion of cases where optical diagnosis derived surveillance intervals concur with histopathology derived surveillance intervals
研究概览
简要总结
This is a prospective feasibility study. The aim of this work is to assess the acceptability and feasibility of optical diagnosis-led care in bowel cancer screening patients undergoing colonoscopy. This study will determine whether bowel cancer screening colonoscopists are able to consistently record and diagnose diminutive adenomas suitable for a resect and discard strategy allowing assignment of surveillance intervals according to Preservation and Incorporation of Valuable Endoscopic Innovations (PIVI) criteria. A practical quality assurance program around optical diagnosis will be introduced. The use of a CAD polyp-detection system will also be evaluated (AI-DETECT).
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
- None
入排标准
- 年龄范围
- 55 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 60-74
- •with +ve Faecal Occult Blood/Faecal Immunochemical test attending for screening colonoscopy within BCSP (Bowel Cancer Screening Programme)
- •with an established history of adenomas attending for surveillance colonoscopy within BCSP
- •Patients aged 55 - referred for screening colonoscopy following positive Bowel Scope Screening flexible sigmoidoscopy
排除标准
- •Patients with a risk profile (due to family history or other) whose follow-up will be outside standard BCSP
- •Patients with inflammatory bowel disease
- •Unable to consent
- •Pregnancy
研究组 & 干预措施
CAD polyp-detection system
In this arm, a CAD polyp detection system will be used during the colonoscopy.
干预措施: CAD polyp-detection system (Diagnostic Test)
Standard (no CAD polyp-detection system)
In this arm, a CAD polyp detection system will not be used during the colonoscopy.
结局指标
主要结局
Proportion of cases where optical diagnosis derived surveillance intervals concur with histopathology derived surveillance intervals
时间窗: 2 weeks for each participant
For each participant, the surveillance interval according to international guidelines (UK, US, European) will be determined based on optical diagnoses alone and then separately based on histopathology results alone. The proportion of cases where both optical diagnosis derived and histopathology derived surveillance intervals agree will be calculated.
Learning curve to achieve accurate optical diagnosis
时间窗: Through study completion, approximately 18-24 months
The investigators will assess endoscopist learning curve by calculating percentage of accurate optical diagnoses of diminutive polyps (when compared with histopathology) for all endoscopists over the course of the study.
Polyp detection rate (AI-DETECT)
时间窗: 2 weeks for each participant
The investigators will assess the impact on polyp detection rate when using a CAD polyp-detection system.
次要结局
- Adenoma detection rate (AI-DETECT)(2 weeks for each participant)
- Sensitivity of optical diagnosis(2 weeks for each participant)
- Specificity of optical diagnosis(2 weeks for each participant)
- Serrated polyp detection rate (AI-DETECT)(2 weeks for each participant)