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A Novel Clinical Decision Support Tool to Predict Submucosal Invasive Cancer Within Large Non-Pedunculated Colorectal Polyps

2026年7月10日更新者：University Hospital, Ghent

Multi-centre Evaluation of a Novel Clinical Decision Support Tool to Predict Submucosal Invasive Cancer Within Large Non-Pedunculated Colorectal Polyps - A Prospective Study

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.

研究概览

地位

招聘中

条件

详细说明

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.

Expert opinion applied to standardized videos serves as the reference standard. Histopathology results are recorded for all resected specimens. An interim analysis is planned when half the required participants are enrolled.

研究类型

观察性的

注册 (估计的)

886

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：David Tate
电话号码：+3293321063
邮箱：studiestissue.resectie@uzgent.be

学习地点

比利时
- - Ghent、比利时、9000
    - 招聘中
    - UZ Gent
    - 接触：
      
      David Tate
      
      电话号码：+3293321063
      
      邮箱：studiestissue.resectie@uzgent.be

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients with large (≥20mm) non-pedunculated colorectal polyps (LNPCPs) detected during colonoscopy or referred for endoscopic resection. Patients with sessile serrated lesions are excluded. Endoscopists must consent and complete the learning intervention. Patients must provide written informed consent for data collection. Participation is voluntary for both groups.

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
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 大体时间：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.	Through study completion, up to 48 months

次要结果测量

结果测量	措施说明	大体时间
Percentage of LNPCP Assessments in Which a Demarcated Area Is Correctly Detected Using the Clinical Decision Support Tool, Compared to Expert Opinion 大体时间：Through study completion, up to 48 months	Endoscopists assess presence/absence of a demarcated area on a standardised endoscopic video using the SMI clinical decision support tool. Expert opinion is the reference standard (considered 100% accurate). Accuracy = proportion of assessments concordant with the expert.	Through study completion, up to 48 months
Inter-observer Agreement Among Endoscopists in Detection of a Demarcated Area Within LNPCPs, Measured by Fleiss' Kappa 大体时间：Through study completion, up to 48 months	Agreement among the multiple participating endoscopists rating the same standardised endoscopic videos, quantified by Fleiss' kappa (appropriate for 3+ raters; corrects for chance agreement).	Through study completion, up to 48 months
Percentage of Demarcated Areas in Which the JNET Classification Is Correctly Determined, Compared to Expert Opinion 大体时间：Through study completion, up to 48 months	Endoscopists assign the JNET (Japan NBI Expert Team) classification to the demarcated area within each LNPCP. Expert opinion is the reference standard (considered 100% accurate). Accuracy = proportion of assessments in which the endoscopist's JNET category matches the expert reference.	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 大体时间：Through study completion, up to 48 months	Each morphological component is assessed by the endoscopist and compared to the expert reference standard (considered 100% accurate). Accuracy = proportion of assessments concordant with the expert, reported separately for size, location, granularity, and Paris classification.	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) 大体时间：Through study completion, up to 48 months		Through study completion, up to 48 months
Endoscopist-Reported Utility of the Clinical Decision Support Tool, Measured by a 5-point Likert-Scale Questionnaire 大体时间：Through study completion, up to 48 months	Participating endoscopists complete a structured questionnaire rating the usability and perceived clinical utility of the tool on a 1-5 Likert scale (1 = not useful, 5 = very useful).	Through study completion, up to 48 months
Difference in Scoring Accuracy Before and After the Educational Intervention, Comparing a 10-minute Instructional Video Versus a 45-minute Interactive Session 大体时间：Through study completion, up to 48 months		Through study completion, up to 48 months
Percentage Accuracy of SMI Detection Using the Clinical Decision Support Tool at 3 Months Post-Intervention 大体时间：3 months after educational intervention	Endoscopists perform a further 10 LNPCP assessments 3 months after the educational intervention, using the SMI clinical decision support tool. Accuracy = proportion of assessments concordant with the expert reference standard (considered 100% accurate). Compared to immediately post-intervention accuracy to assess durability of the learning effect.	3 months after educational intervention

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Ghent

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年10月1日

初级完成 (估计的)

2030年9月1日

研究完成 (估计的)

2030年9月30日

研究注册日期

首次提交

2026年6月4日

首先提交符合 QC 标准的

2026年7月10日

首次发布 (实际的)

2026年7月15日

研究记录更新

最后更新发布 (实际的)