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Clinical Trials/NCT06193356
NCT06193356RecruitingNot Applicable

Detection of Endoscopic Resection Scars and Delineation of Recurrence Amongst Non-experts is Less Accurate Than Experts But Trainable in a Short Learning Intervention

University Hospital, Ghent2 sites in 1 country141 target enrollmentStarted: November 11, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
141
Locations
2
Primary Endpoint
Performance of detecting a recurrence at an endoscopic resection scar.

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Endoscopists of any experience level

Exclusion Criteria

  • non consenting adults

Outcomes

Primary Outcomes

Performance of detecting a recurrence at an endoscopic resection scar.

Time Frame: 2 years

Performance of detecting a recurrence at an endoscopic resection scar.

Secondary Outcomes

  • 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(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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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