NCT06193356 Detection of Endoscopic Resection Scars and Delineation of Recurrence is Trainable
| NCT ID | NCT06193356 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Ghent |
| Condition | Colorectal Polyp |
| Study Type | INTERVENTIONAL |
| Enrollment | 141 participants |
| Start Date | 2024-11-11 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 141 participants in total. It began in 2024-11-11 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Endoscopists of any experience level Exclusion Criteria: * non consenting adults
Contact & Investigator
David J Tate, PhD
PRINCIPAL INVESTIGATOR
UZ Ghent
Frequently Asked Questions
Who can join the NCT06193356 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Polyp. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06193356 currently recruiting?
Yes, NCT06193356 is actively recruiting participants. Contact the research team at David.tate@uzgent.be for enrollment information.
Where is the NCT06193356 trial being conducted?
This trial is being conducted at Ghent, Belgium.
Who is sponsoring the NCT06193356 clinical trial?
NCT06193356 is sponsored by University Hospital, Ghent. The principal investigator is David J Tate, PhD at UZ Ghent. The trial plans to enroll 141 participants.