Evaluating a Web-Based Tool to Detect Invasive Cancer in Large Non-Pedunculated Colorectal Polyps During Colonoscopy

What this Trial Is About

Colorectal cancer can often be prevented by removing pre-malignant polyps during colonoscopy. Large non-pedunculated colorectal polyps LNPCPs measuring 20mm or more need careful evaluation because the presence of submucosal invasive cancer SMI determines if endoscopic treatment alone is enough or if surgery is required. Existing classification methods for detecting SMI are complex and underused in many hospitals, so a simpler approach is needed. A new web-based clinical decision support tool has been developed using common endoscopic features like demarcated areas, polyp size, Paris classification, location, and granularity to help identify SMI in LNPCPs. This tool uses standard imaging available in most endoscopy units. The study is a prospective multicenter trial across several countries, where endoscopists of varying experience assess sets of 10 large polyps using the tool before and after randomized educational interventions, including a short instructional video or a longer interactive session. A follow-up assessment at 3 months checks how well the learning is retained. Participants include endoscopists who assess live colonoscopies with the tool and create standardized videos of lesions for expert comparison. Various accuracy and agreement measures are recorded throughout the study, alongside histology results of resected polyps. The study tracks performance before training, immediately after, and three months later, lasting up to 48 months. Safety and data quality are monitored continuously, and expert opinion serves as the reference standard for assessment accuracy.

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