A web-based tool to help predict submucosal invasive cancer in large non-pedunculated colorectal polyps

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-center observational study across eight centers in Europe and Israel. It evaluates a freely accessible web-based clinical decision support tool that uses standard endoscopic imaging to identify submucosal invasive cancer within large non-pedunculated polyps (≥20 mm). Endoscopists of varying experience assess polyps with the tool during live procedures, after which they receive targeted training and re-assess, enabling a pre-post evaluation of diagnostic accuracy. The tool relies on established risk factors such as demarcated area, size, Paris classification, location, and granularity. The trial aims to determine whether the tool improves decision-making about endoscopic treatment versus referral for surgery, in non-tertiary practice settings.

Why it matters

Who can join: the full rules

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

Where it's running

• UZ Gent
  Ghent, Belgium Recruiting

Study contacts

• Study coordinator: David Tate
• Email: studiestissue.resectie@uzgent.be
• Phone: +3293321063

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.