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Effect of a computer-aided detection system (CAD EYE) on adenoma detection in patients with Lynch syndrome: an international, multicenter parallel randomized controlled trial

Effect of a computer-aided detection system (CAD EYE) on adenoma detection in patients with Lynch syndrome: an international, multicenter parallel randomized controlled trial - CAD EYE LYNCH

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51017
Enrollment
160
Registered
2021-09-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lynch syndrom polyps

Interventions

HD-WL endoscopy with computer aided detection system

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Diagnosis of Lynch-syndrome, with a germline mutation in one of the MMR genes (MLH1, MSH2, MSH6) or deletions in the 3* region of the EpCAM gene - Age >18 years - Surveillance colonoscopy for Lynch syndrome.

Exclusion criteria

Exclusion criteria: - Recent surveillance colonoscopy within 1 year from current exam (e.g. after piecemeal EMR) or patients referred for endoscopic evaluation of known colorectal neoplasia. - Colonoscopy planned for the evaluation of symptoms like rectal blood loss, recent change in bowel habits, weight loss or anemia. - Patients with a concurrent diagnosis of (serrated) polyposis syndrome or inflammatory bowel disease. - Patients who are unwilling or unable to give informed consent.

Design outcomes

Primary

MeasureTime frame
Adenoma detection rate of colonoscopy with CADe system versus colonoscopy without CADe system

Secondary

MeasureTime frame
- The difference in polyp detection rate between colonoscopy with and without CADe system - The difference in mean number of polyps between colonoscopy with and without CADe system - The difference in mean number of adenomas between colonoscopy with and without CADe system - The difference in mean number of serrated polyps between colonoscopy with and without CADe system - The difference in proximal serrated polyp detection rate between colonoscopy with and without CADe system - The difference in mean number of proximal serrated polyps between colonoscopy with and without CADe system - The mean duration of both endoscopic procedures with and without CADe system: time for inspection and time for performing endoscopic resection - False positive detections of the CADe system: a flashing alert (whereby a detection box, circle and/or sound signal appears then disappears) and consistent false detection (whereby the CADe system consistently identifies a non-polyp structure as a polyp but the endoscopist disagrees at close observation)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)