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NCT06193356 Clinical Trial

Detection of Endoscopic Resection Scars and Delineation of Recurrence is Trainable

Colorectal Cancer Clinical Trial

— SCAR  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06193356
Other study ID # ONZ-2024-0133
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2024
Est. completion date January 1, 2027

Study information
Verified date April 2024
Source University Hospital, Ghent
Contact David J trate, PhD
Phone 09 332 21 11
Email David.tate@uzgent.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 141
Est. completion date January 1, 2027
Est. primary completion date January 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Endoscopists of any experience level Exclusion Criteria: - non consenting adults

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Learning tool
Video based learning tool about detection of endoscopic resection scars and recurrence.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Outcome
Type Measure Description Time frame Safety issue
Primary Performance of detecting a recurrence at an endoscopic resection scar. Performance of detecting a recurrence at an endoscopic resection scar. 2 years
Secondary Performance of a learning tool in improving detection of recurrence at an endoscopic resection scar Performance of a learning tool in improving detection of recurrence at an endoscopic resection scar 2 year
Secondary Difference in performance of detecting a recurrence at an endoscopic resection scar between endoscopists with different experience level Difference in performance of detecting a recurrence at an endoscopic resection scar between endoscopists with different experience level 2 year
Secondary Performance of a learning tool in improving detection of recurrence at an endoscopic resection scar compared between endoscopists with different experience level Performance of a learning tool in improving detection of recurrence at an endoscopic resection scar compared between endoscopists with different experience level 2 year
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