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
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: June 2024
• Source: University Hospital, Ghent
• Contact: David J trate, PhD
• Phone: 09 332 21 11
• Email: David.tate[@]uzgent.be
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Polyp
• Recurrence

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