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Endocytoscopic identification of dysplasia in the Barrett’s esophagus using artificial intelligence as a second assessor: a prospective assessment of the interaction between gastroenterologists and a convolutional neural network

Endocytoscopic identification of dysplasia in the Barrett’s esophagus using artificial intelligence as a second assessor: a prospective assessment of the interaction between gastroenterologists and a convolutional neural network

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27377
Enrollment
52
Registered
2020-05-01
Start date
2019-02-05
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Barrett's esophagus, (low/high grade) dysplasia, esophageal adenocarcinoma

Interventions

None listed

Sponsors

University Medical Center Groningen (UMCG)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: o Patients with established BE scheduled for gastroscopy due to surveillance examination; o Patients with established BE and a malignant visible lesion scheduled for gastroscopy due to endoscopic mucosal resection (EMR) or Endoscopic Submucosal Dissection (ESD). o Age = 18 years; o Written informed consent.

Exclusion criteria

Exclusion criteria: o Age younger than 18 years o Inability to give written informed consent for the study

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy is defined as sensitivity, specificity, predictive value and likelihood ratio’s. Measures: true positives, true negatives, false positives and false negatives of endocytoscopy procedure. Gold standard for comparison is the histopathological result of biopsy which will be extracted from reports of patients’ digital medical chart for which they will have to provide consent.

Secondary

MeasureTime frame
Kappa values for inter-observer agreement. Procedural qualities will consist of the rating of image quality and additional procedural time for making endocytoscopic images. Basic demographic data: gender, year of birth.

Contacts

Public ContactJouke van der Laan

Universitair Medisch Centrum Groningen

j.j.h.van.der.laan@umcg.nl+31633719138

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)