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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Does not consent to inclusion

Does not undergo the learning intervention

No connection with endoscopy in gastroenterology

Does not consent to data collection for the study

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators