We hypothesise that Endocytoscopy is feasible to detect dysplasia/carcinoma in patients with BE
Bron
Aandoening
Barrett's esophagus, (low/high grade) dysplasia, esophageal adenocarcinoma
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
Current time-consuming surveillance strategies may miss early esophageal adenocarcinoma (EAC) lesions and thus impede curative endoscopic resection methods. An approach with targeted biopsies in the Barrett's esophagus (BE) may increase effectiveness of surveillance examination. Endocytoscopy (EC) is an ultra-magnification endoscopy technique that allows real-time in vivo visualisation of the mucosal histology and cytology . First, we will perform endoscopic examination through EC in BE patients to acquire EC frames of the BE. Subsequently, based upon reviewing the EC frames, we will develop an in vivo EC classification system in order to discriminate non-dysplastic from dysplastic BE tissue. Clinicians will be trained and tested in handling this classification system during online modules that include a training program and two test sets. Furthermore, we will investigate the applicability of Artificial Intelligence (AI) in analysing EC images and assess its performance in comparison to and in cooperation with clinicians.
Doel van het onderzoek
We hypothesise that Endocytoscopy is feasible to detect dysplasia/carcinoma in patients with BE
Onderzoeksopzet
30-04-2020 interim analysis
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
o Age younger than 18 years
o Inability to give written informed consent for the study
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL8573 |
Ander register | IRB UMCG : 201900099 |