Detection of buried Barrett glands after Radiofrequency Ablation (RFA) with Volumetric Laser Endomicroscopy (VLE); a histopathology correlation study. vs 2.0

Completed

• Conditions: 1) Buried Barrett's 2) Occult buried glandular mucosa; 10017990

• Registration Number: NL-OMON40907
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Age > 18 * 80 years; - Patients post RFA treatment with 100% endoscopic regression of Barrett*s epithelium; - Minimum circumferential Barrett*s extent of 2 cm prior to ablation therapy; - Signed informed consent.

Exclusion Criteria

- Presence of significant stenosis; - Presence of erosive esophagitis; - Inability to undergo ER and/or obtain biopsies (e.g. due to anticoagulation, coagulation disorders, varices); - Unable to provide signed informed consent.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Presence of structures suggesting BB on VLE; - VLE characteristics of buried<br /><br>glands (e.g. sparsely distributed hyposcattering structures underneath NSE with<br /><br>various sizes and shapes) - Number of glands - Size of glands - Location of<br /><br>glands from GEJ - Depth level of glands - Consensus confidence level of BB<br /><br>detection in targeted suspicious area - Presence of structures suggesting of BB<br /><br>in ER specimens and, if present: - Number of glands - Size of glands - Location<br /><br>of glands from GEJ - Depth level of glands - Histology: Intestinal metaplasia,<br /><br>Dysplasia Correlation of OFDI images with corresponding histology of ER<br /><br>specimen</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-</p><br>