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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24516
Enrollment
10
Registered
2013-07-01
Start date
2013-07-12
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Barrett's esophagus Buried Barrett's Barrett slokdarm

Interventions

The study uses the VLE catheter to examine and scan the distal Barrett's esophagus. VLE is an advanced imaging technique that has the potential to visualize subsquamous structures in Barrett's esophag

Sponsors

AMC Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 – 80 years; 2. Patients post RFA treatment with 100% endoscopic regression of Barrett’s epithelium; 3. Minimum circumferential Barrett’s extent of 2 cm prior to ablation therapy; 4. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Presence of significant stenosis; 2. Presence of erosive esophagitis; 3. Inability to undergo ER and/or obtain biopsies (e.g. due to anticoagulation, coagulation disorders, varices); 4. Unable to provide signed informed consent.

Design outcomes

Primary

MeasureTime frame
1. Presence of structures suggesting BB on VLE; 2. 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 3.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 4. Histology: Intestinal metaplasia, Dysplasia Correlation of OFDI images with corresponding histology of ER specimen

Contacts

Public ContactJ.J.G.H.M. Bergman

Academic Medical Center Bldg. C2-210, Meibergdreef

j.j.bergman@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)