Detection of Endoscopic Resection Scars and Delineation of Recurrence is Trainable

NCT ID: NCT06193356

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-11

Study Completion Date

2027-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Polyp Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pre learning tool

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

Group Type NO_INTERVENTION

No interventions assigned to this group

post learning tool

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

Group Type EXPERIMENTAL

Learning tool

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Learning tool

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Endoscopists of any experience level

Exclusion Criteria

* non consenting adults
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David J Tate, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Ghent

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UZ Gent

Ghent, , Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

David J trate, PhD

Role: CONTACT

09 332 21 11 ext. +32

Sander Smeets, MD

Role: CONTACT

09 332 21 11 ext. +32

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ONZ-2024-0133 - ID16649

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.