Clinical trial NCT06193356: Detection of Endoscopic Resection Scars and Delineation of Recurrence is Trainable
Official title: Detection of Endoscopic Resection Scars and Delineation of Recurrence Amongst Non-experts is Less Accurate Than Experts But Trainable in a Short Learning Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Polyp
Colorectal Cancer
Keywords: endoscopy
advanced imaging
post-colonoscopy colorectal cancer
Colorectal polypectomy
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: DIAGNOSTIC

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

Primary outcomes:
measure: Performance of detecting a recurrence at an endoscopic resection scar.
timeFrame: 2 years
Secondary outcomes:
measure: Performance of a learning tool in improving detection of recurrence at an endoscopic resection scar
timeFrame: 2 year
measure: Difference in performance of detecting a recurrence at an endoscopic resection scar between endoscopists with different experience level
timeFrame: 2 year
measure: Performance of a learning tool in improving detection of recurrence at an endoscopic resection scar compared between endoscopists with different experience level
timeFrame: 2 year
Other outcomes:
Locations:
Study officials:
affiliation: UZ Ghent
name: David J Tate, PhD
role: PRINCIPAL_INVESTIGATOR
References: