Feasibility of Computer guided Volumetric Laser Endomicroscopy (VLE) Targeted Biopsies for Improved Detection of Early Barrett*s Neoplasia

Withdrawn

Conditions: Barrett's esophagus
early esophageal cancer
10017990

Registration Number: NL-OMON48059

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

* 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);

Exclusion Criteria

* 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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>a) Can the suspicious regions of interest, which are predicted by VLE-CAD, be<br /><br>targeted by laser marking?<br /><br>Questionnaire analysis using Likert scale: 1-5<br /><br><br /><br>b) Feasibility of workflow? Questionnaire analysis using Likert scale: 1-5</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>a) Diagnostic performance of CAD targeted biopsies (sensitivity, specificity)<br /><br><br /><br>b) Proportion of VLE-CAD guided biopsies positive for dysplasia, assessed at a<br /><br>per biopsy & per patient level<br /><br><br /><br>c) Safety<br /><br>- Number of (serious) adverse events related to VLE-CAD guided biopsies<br /><br><br /><br>d) VLE procedure time, including image acquisition and targeting, not including<br /><br>time for biopsy or resection.<br /><br><br /><br>e) Total number of VLE-CAD guided biopsies per patient</p><br>