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

Detection of buried Barrett glands after Radiofrequency Ablation (RFA) with Volumetric Laser Endomicroscopy (VLE); a histopathology correlation study. vs 2.0 - nVision BB 2

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40907

Enrollment

Registered

2014-03-18

Start date

2014-03-31

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1) "Buried Barrett's" 2) Occult buried glandular mucosa

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
-	—

Countries

Netherlands

Outcome results