- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06193356
Detection of Endoscopic Resection Scars and Delineation of Recurrence is Trainable (SCAR)
Detection of Endoscopic Resection Scars and Delineation of Recurrence Amongst Non-experts is Less Accurate Than Experts But Trainable in a Short Learning Intervention
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Colorectal cancer is prevented by polypectomy. Failure to recognize the scar after 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David J trate, PhD
- Phone Number: +32 09 332 21 11
- Email: David.tate@uzgent.be
Study Contact Backup
- Name: Sander Smeets, MD
- Phone Number: +32 09 332 21 11
- Email: sander.smeets@uzgent.be
Study Locations
-
-
-
Ghent, Belgium, 9000
- Recruiting
- UZ Gent
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Endoscopists of any experience level
Exclusion Criteria:
- non consenting adults
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Pre learning tool
Assessment of endoscopic images prior to a learning tool about scars and recurrence
|
|
|
Experimental: post learning tool
Assessment of endoscopic images after a learning tool about scars and recurrence
|
Video based learning tool about detection of endoscopic resection scars and recurrence.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance of detecting a recurrence at an endoscopic resection scar.
Time Frame: 2 years
|
Performance of detecting a recurrence at an endoscopic resection scar.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance of a learning tool in improving detection of recurrence at an endoscopic resection scar
Time Frame: 2 year
|
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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David J Tate, PhD, UZ Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONZ-2024-0133 - ID16649
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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