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

NCT07705880 | Recruiting DMC

• 1 other identifier: ONZ-2022-0256
• Study Type: observational
• Target: 886
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

submucosal invasive cancer; Large non-pedunculated colorectal polyps; Clinical decision support tool; Endoscopic assessment; LNPCP

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, up to 48 months

Secondary Outcomes (8)

• Percentage of LNPCP Assessments in Which a Demarcated Area Is Correctly Detected Using the Clinical Decision Support Tool, Compared to Expert Opinion

  Through study completion, up to 48 months

• Inter-observer Agreement Among Endoscopists in Detection of a Demarcated Area Within LNPCPs, Measured by Fleiss' Kappa

  Through study completion, up to 48 months

• Percentage of Demarcated Areas in Which the JNET Classification Is Correctly Determined, Compared to Expert Opinion

  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

  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)

  Through study completion, up to 48 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• Endoscopist participants:
• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

UZ Gent

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

David Tate

CONTACT

+3293321063; studiestissue.resectie@uzgent.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: July 15, 2026
• Study Start: October 1, 2022
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)