An observational study in Colorectal Neoplasms and Colonic Polyps, sponsored by University Hospital, Ghent. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University Hospital, Ghent · Observational
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 45-minute structured educational intervention. 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.
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:
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.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 886 is above the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Endoscopist participants
Exclusion Criteria:
Endoscopist participants:
Patient participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 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
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.
Time frame: Through study completion, up to 48 months
Inter-observer Agreement Among Endoscopists in Detection of a Demarcated Area Within LNPCPs, Measured by Fleiss' Kappa
Agreement among the multiple participating endoscopists rating the same standardised endoscopic videos, quantified by Fleiss' kappa (appropriate for 3+ raters; corrects for chance agreement).
Time frame: Through study completion, up to 48 months
Percentage of Demarcated Areas in Which the JNET Classification Is Correctly Determined, Compared to Expert Opinion
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.
Time frame: 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
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.
Time frame: 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)
Time frame: Through study completion, up to 48 months
Endoscopist-Reported Utility of the Clinical Decision Support Tool, Measured by a 5-point Likert-Scale Questionnaire
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).
Time frame: Through study completion, up to 48 months
Difference in Scoring Accuracy Before and After the 45-minute Structured Educational Intervention
Time frame: Through study completion, up to 48 months
Percentage Accuracy of SMI Detection Using the Clinical Decision Support Tool at 3 Months Post-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.
Time frame: 3 months after educational intervention
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