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Neosquamous epithelium after radiofrequency ablation (RFA) of Barrett epithelium: Where does it come from?

Neosquamous epithelium after radiofrequency ablation (RFA) of Barrett epithelium: Where does it come from? - NSE-regeneration

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON32517
Enrollment
10
Registered
2008-10-24
Start date
2008-10-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Barrett esophagus heartburn

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Age 18-85 years; * Circumferential Barrett segment of 3-8 cm; * Scheduled for primary circumferential RFA of Barrett epithelium with flat low-grade or high-grade intraepithelial neoplasia, or residual Barrett epithelium (with or without neoplasia) after prior endoscopic resection for lesions containing high-grade intraepithelial neoplasia and/or cancer; * No esophageal stricturing, defined as difficulties when passing a therapeutic endoscope; * Written informed consent.

Exclusion criteria

Exclusion criteria: * In the case of an endoscopic resection, histological evaluation showing: signs of deep submucosal infiltration (>T1sm1), poorly or undifferentiated cancer, irradical resection at the deep resection margin, or lymphatic/vascular invasion; * Visible lesions in the Barrett segment prior to RFA; * Any biopsy with residual cancer after the endoscopic resection; * Unable to sign informed consent.

Design outcomes

Primary

MeasureTime frame
1. Morphological stages of the epithelium during the squamous regeneration process after RFA. 2. Expression of relevant proteins in the epithelium during the squamous regeneration process after RFA. 3. Presence of loss of heterozygosity and single-nucleotide polymorphisms in the regenerating NSE, in the submucosal gland ducts in BE, and in normal squamous epithelium.

Secondary

MeasureTime frame
1. Morphological characteristics of NSE compared to untreated squamous epithelium. 2. Expression of relevant proteins with immunohistochemical staining in NSE and in untreated squamous epithelium.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)