VLE computer algorithm is feasible for obtaining real-time targeted biopsies for improved detection of BE neoplasia
ID
Bron
Verkorte titel
Aandoening
Barrett esophagus with and without neoplasia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Feasibility of a real-time VLE computer algorithm for the detection of BE neoplasia
Achtergrond van het onderzoek
Feasibility of a volumetric laser endomicroscopy (VLE) computer algorithm is evaluated for obtaining real-time targeted biopsies for improved detection of early Barrett's neoplasia
Doel van het onderzoek
VLE computer algorithm is feasible for obtaining real-time targeted biopsies for improved detection of BE neoplasia
Onderzoeksopzet
1 endoscopy where the algorithm is evaluated. Histopathology is checked subsequently to assess the diagnostic yield
Onderzoeksproduct en/of interventie
Endoscopy as planned for routine clinical care, where VLE algorithm targeted biopsies are evaluated for the detection of BE neoplasia
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Age > 18 years;
• Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation.
• Minimum Barrett’s extent (from Prague criteria) M ≥ 2cm;
• Known BE, defined as columnar lined epithelium of the esophagus containing intestinal metaplasia upon biopsy, with or without dysplasia (low-grade or high-grade dysplasia or early adenocarcinoma);
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Presence of an esophageal mass that precludes full distention of the balloon from the NvisionVLE Optical Probe;
• Patients with known esophageal strictures, esophageal tears or ulcers, which would prohibit full distention of the balloon from the NvisionVLE Optical Probe;
• Contraindications for endomucosal resection (EMR) and/or obtaining biopsies (e.g. due to anticoagulation, coagulation disorders, esophageal varices);
• Patients within four weeks of receiving targeted forceps biopsies and/or EMR;
• Unable to provide signed informed consent.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8133 |
| Ander register | METC AMC : METC 2019_195 |