Multi-centre Evaluation of a Novel Clinical Decision Support Tool to Predict Submucosal Invasive Cancer Within Large Non-Pedunculated Colorectal Polyps - A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 886
- 试验地点
- 1
- 主要终点
- Accuracy of Endoscopic Assessment of the Risk of Submucosal Invasive Cancer Within LNPCPs Using the Clinical Decision Support Tool Compared to Expert Opinion During Live Endoscopy
研究概览
简要总结
Colorectal cancer can be effectively prevented by removal of pre-malignant polyps during colonoscopy. Large (>=20mm) non-pedunculated colorectal polyps (LNPCPs) require careful assessment before treatment. If submucosal invasive cancer (SMI) is present, it determines whether endoscopic treatment can be curative or whether surgery is needed. Current classification systems to detect SMI are complex, require extensive training, and are underused in non-tertiary hospitals.
A simple web-based clinical decision support tool was created using well-established parameters (presence of a demarcated area, polyp size, Paris classification, location, and granularity) to identify SMI within LNPCPs. Crucially, the tool uses only standard endoscopic imaging available in most endoscopy units.
This prospective multi-centre study evaluates the accuracy of the tool during live endoscopic assessment. Endoscopists of varying experience will assess 10 large colorectal polyps using the tool, then undergo a randomized educational intervention (either a 10-minute instructional video or a 45-minute interactive training session). They will then assess a further 10 polyps using the tool. A third set of 10 assessments at 3 months evaluates durability of learning. Accuracy is compared to expert opinion.
详细描述
Colorectal cancer (CRC) is a leading cause of death in the Western world. Large non-pedunculated colorectal polyps (LNPCPs, >=20mm) represent 2-3% of colorectal polyps and require special attention. The presence of submucosal invasive cancer (SMI) determines whether endoscopic treatment is curative or whether referral for surgery is necessary. Current endoscopic classification systems (JNET, Kudo, NICE) are complex, require specialized equipment, and extensive training, making them underused in non-tertiary practice.
A novel, freely accessible web-based clinical decision support tool (available at gieqs.com/SMI) was developed based on established risk factors for SMI: the presence and characteristics of a demarcated area within the polyp, polyp size (>=40mm), Paris classification, colonic location, and granularity. The tool uses only standard white-light and virtual chromoendoscopy available in the majority of Western endoscopy units.
This is a prospective, multi-centre study conducted across 8 centres in Belgium, the United Kingdom, Israel, and Italy. The study evaluates whether endoscopists of varying experience can accurately detect SMI within LNPCPs during live colonoscopy using this tool.
The study follows a pre-post design with randomization of the educational intervention:
- Phase 1 (Pre-training): Each endoscopist assesses 10 eligible LNPCPs using a standardized assessment and creates a 1-minute standardized video of each lesion.
- Educational Intervention: Endoscopists are randomly allocated (1:1) to either (a) a 10-minute non-dynamic instructional video or (b) a 45-minute interactive educational session.
- Phase 2 (Post-training): Each endoscopist assesses a further 10 LNPCPs using the clinical decision support tool.
- Phase 3 (Durability): At 3 months, a further 10 assessments are performed to evaluate durability of the training effect.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Endoscopist participants
- •Gastrointestinal endoscopists of varying abilities and grades
- •Endoscopists who have not previously encountered the clinical decision support tool Patient participants
- •Referred for colonoscopy with appropriate bowel preparation
- •Colorectal polyp >=20mm in size detected or referred for resection
- •Non-pedunculated morphology
- •Non-sessile serrated morphology
- •Signed informed consent for the procedure and trial participation
排除标准
- •Endoscopist participants:
- •Does not consent to inclusion
- •Does not undergo the learning intervention
- •No connection with endoscopy in gastroenterology
- •Patient participants:
- •Does not consent to data collection for the study
- •Video of inadequate quality as per opinion of the principal investigator
结局指标
主要结局
Accuracy of Endoscopic Assessment of the Risk of Submucosal Invasive Cancer Within LNPCPs Using the Clinical Decision Support Tool Compared to Expert Opinion During Live Endoscopy
时间窗: Through study completion, up to 48 months
The accuracy of each endoscopist's assessment of SMI risk using the tool, compared to expert opinion applied to a standardised video of the same procedure. Measured as sensitivity, specificity, and overall accuracy across pre-training, post-training, and 3-month durability phases.
次要结局
- Difference in Scoring Accuracy Before and After the Educational Intervention, Comparing a 10-minute Instructional Video Versus a 45-minute Interactive Session(Through study completion, up to 48 months)
- Percentage of LNPCP Assessments in Which a Demarcated Area Is Correctly Detected Using the Clinical Decision Support Tool, Compared to Expert Opinion(Through study completion, up to 48 months)
- Inter-observer Agreement Among Endoscopists in Detection of a Demarcated Area Within LNPCPs, Measured by Fleiss' Kappa(Through study completion, up to 48 months)
- Percentage of Demarcated Areas in Which the JNET Classification Is Correctly Determined, Compared to Expert Opinion(Through study completion, up to 48 months)
- Percentage of Lesions in Which Each Morphological Component (Size, Location, Granularity, Paris Classification) Is Correctly Determined, Compared to Expert Opinion(Through study completion, up to 48 months)
- Correct Treatment Decision Based Upon the Tool Score (Rate of Unnecessary Surgery for Benign Disease or Unnecessary Endoscopic Treatment Requiring Subsequent Surgery)(Through study completion, up to 48 months)
- Endoscopist-Reported Utility of the Clinical Decision Support Tool, Measured by a 5-point Likert-Scale Questionnaire(Through study completion, up to 48 months)
- Percentage Accuracy of SMI Detection Using the Clinical Decision Support Tool at 3 Months Post-Intervention(3 months after educational intervention)