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

Completed

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

• Registration Number: NL-OMON38462
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 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;<br /><br>- VLE characteristics of buried glands (e.g. sparsely distributed<br /><br>hyposcattering structures underneath NSE with various sizes and shapes)<br /><br>- Number of glands<br /><br>- Size of glands<br /><br>- Location of glands from GEJ<br /><br>- Depth level of glands<br /><br><br /><br>Presence of structures suggesting of BB in ER specimens and, if present:<br /><br>- Number of glands<br /><br>- Size of glands<br /><br>- Location of glands from GEJ<br /><br>- Depth level of glands<br /><br>- Histology: Intestinal metaplasia, Dysplasia<br /><br><br /><br>Correlation of OFDI images with corresponding histology of ER specimen</p><br>

Secondary Outcome Measures

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