Detection of Endoscopic Resection Scars and Delineation of Recurrence is Trainable

NCT06193356 | Recruiting

• 1 other identifier: ONZ-2024-0133 - ID16649
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is prevented by colonoscopy and polypectomy. Failure to recognize the endoscopic resection scar after Endoscopic Mucosal Resection (EMR) risks unrecognized recurrent or residual adenoma (RRA), which may propagate into post-colonoscopy colorectal cancer. Expert series suggest scar recognition and interrogation is well performed with a high negative predictive value of endoscopic imaging vs histopathology. In this study the authors will investigate the performance of endoscopic imaging in detecting RRA at an endoscopic resection scar amongst general endoscopist and the impact of a learning intervention on recognition of RRA. After consent is given, the participant will open the online survey and fill this in. First the participant will be asked to create a pseudonym (name+year of birth) and fill in their demographical information (Grade, years in current role, colonoscopy experience, experience of colonic tissue resection, country of employment The first 15 pictures will be shown prior to a learning intervention. For each picture the same questions will be asked:

• Is this an endoscopic resection scar?
• Based on this image does the scar demonstrate evidence of residual or recurrent adenoma (RRA)?
• What is your level of confidence?
• If the scar shows RRA, how would you treat it? (skip if you feel no RRA).
• If the scar does not show RRA do you feel there is another diagnosis? After the first 15 pictures a video-based learning tool will be shown on detection of RRA. After the learning tool 15 different pictures will be shown, the same questions will be asked. All responses will be collected by the investigators. Statistical analysis will be performed using visual studio code (Microsoft, Redmond, USA) Images will be selected from the 'Australian Colonic LSL Endoscopic Resection Study' (ACE) database, which is an international multicentre registry of images and videos for retrospective analysis of colonic lesions. Images, videos, procedural information, and histopathological data are stored on a secure online web portal after written informed consent of every participating patient.

Conditions

Colorectal Polyp; Colorectal Cancer

Keywords

endoscopy; advanced imaging; post-colonoscopy colorectal cancer; Colorectal polypectomy

Outcome Measures

Primary Outcomes (1)

• Performance of detecting a recurrence at an endoscopic resection scar.

  Performance of detecting a recurrence at an endoscopic resection scar.

  2 years

Secondary Outcomes (3)

• Performance of a learning tool in improving detection of recurrence at an endoscopic resection scar

  2 year

• Difference in performance of detecting a recurrence at an endoscopic resection scar between endoscopists with different experience level

  2 year

• Performance of a learning tool in improving detection of recurrence at an endoscopic resection scar compared between endoscopists with different experience level

  2 year

Study Arms (2)

Pre learning tool

NO INTERVENTION

Assessment of endoscopic images prior to a learning tool about scars and recurrence

post learning tool

EXPERIMENTAL

Assessment of endoscopic images after a learning tool about scars and recurrence

Other: Learning tool

Interventions

Learning tool OTHER

Video based learning tool about detection of endoscopic resection scars and recurrence.

post learning tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Endoscopists of any experience level

You may not qualify if:

• non consenting adults

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

UZ Gent

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• David J Tate, PhD

  UZ Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David J trate, PhD

CONTACT

09 332 21 11; David.tate@uzgent.be

Sander Smeets, MD

CONTACT

09 332 21 11; sander.smeets@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A survey containing 15 High Definition - White Light (HD-WL) and Narrow Band Imaging (NBI) images, a learning intervention on detection of RRA (LT), then another set of 15 images was circulated to a mailing list of the GIEQs (Gastrointestinal Endoscopy Quality and Safety) foundation. Each image contained the same questions: Is this a resection scar? Is there RRA? What is your level of confidence? Information on the participant was obtained: number of EMRs performed, grade (consultant vs trainee) and years of experience. Comparisons were made to expert opinion derived at a consensus meeting of the senior authors regarding the appearances of the scars using the approach set out in Desomer et al. 2017.

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: November 11, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)