MedTrace Logo

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

NCT07705880 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 886

Last updated 2026-07-15

No results posted yet for this study

Summary

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.

Conditions

  • Colorectal Neoplasms
  • Colonic Polyps

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2030-09-30
Completion
2030-09-30

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07705880 on ClinicalTrials.gov