Evaluation of a real-time computer aided detection and diagnosis system of Barrett's neoplasia during live endoscopic procedures: A multicenter prospective study

• Conditions: Esophageal Adenocarcinoma; 10017990; esophageal cancer; 10017991

• Registration Number: NL-OMON56957
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

- BE patients without prior treatment that are undergoing regular endoscopic
surveillance, or an endoscopic treatment in the Barrett segment.
- Age >= 18 years
- Signed informed consent

Exclusion Criteria

- Prior endoscopic or surgical treatment of the esophagus for neoplasia
- Reflux esophagitis > grade B (LA classification)
- Inability to undergo EMR/ESD and/or obtain biopsies (e.g. due to
anticoagulation, coagulation disorders, varices)

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Per patient combined CADe/CADx sensitivity (i.e. number of patients with a<br /><br>visible abnormality detected by CAD on at least one Barrett level, divided by<br /><br>the total number of neoplasia patients according to the gold standard). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Per patient combined CADe/CADx specificity (i.e. number of patients without a<br /><br>visible abnormality where CAD does not identify a lesion on any level, divided<br /><br>by the total number of NDBE patients according to the gold standard).<br /><br>- Per level combined CADe/CADx sensitivity and specificity (i.e. number of<br /><br>levels with a visible abnormality identified by CADe/CADx, and number of levels<br /><br>without a visible abnormality where CADe/CADx does not identify a lesion; both<br /><br>divided by the total number of neoplasia/NDBE levels according to the gold<br /><br>standard).<br /><br>- Per patient and per level CADe sensitivity and specificity </p><br>