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Characterization of the Neo-squamous Epithelial Barrier

Prospective Characterization of the Neo-squamous Epithelial Barrier Following Successful Endoscopic Therapy in Barrett's Esophagus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03077594
Enrollment
53
Registered
2017-03-13
Start date
2016-09-26
Completion date
2022-06-29
Last updated
2023-01-18

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

Conditions

Barrett's Esophagus With Dysplasia

Brief summary

To prospectively assess the functional aspects of the the esophageal squamous epithelial barrier and correlate this with tissue inflammation and intercellular space dilation in patients who have successfully completed endoscopic radiofrequency ablation versus balloon cryotherapy for Barrett's Esophagus related metaplasia.

Detailed description

The investigators will measure and correlate mucosal impedance (measured using a novel endoscopic mucosal impedance catheter), intercellular space as measured with transmission electron microscopy and tissue levels of prostaglandin E2 in patients undergoing surveillance following successful endoscopic therapy (defined as two negative endoscopic surveillance histology for intestinal metaplasia). Mucosal impedance will be measured by an endoscopic probe. Research biopsies will also be obtained for measurement of tissue levels of prostaglandin E2 and intracellular space with transmission electron microscopy. Volumetric laser endomicroscopy will measure the precise thickness of and area of subsquamous structures underneath the neosquamous epithelium.

Interventions

Aim 1: Mucosal impedance will be measured by an endoscopic probe 1 cm above the gastroesophageal junction, 5 cm above the gastroesophageal junction and in the proximal esophagus in an area not exposed to the index therapeutic radiofrequency ablation. Aim 2: Mucosal impedance will be measured 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.

Aim 1: Research biopsies will be obtained at 1 cm above the gastroesophageal junction, 5 cm above the gastroesophageal junction, and in the proximal esophagus in an area not exposed to the index therapeutic radiofrequency ablation. Aim 2: Aim 2: Research biopsies will be taken 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.

DEVICEVolumetric Laser Endomicroscopy

Aim 2: Volumetric laser endomicroscopy will be done and marked at 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Adults (age 18-90) who underwent an ablative program for BE

Exclusion criteria

* Patients that have not achieved complete remission of intestinal metaplasia. * Patients unable to consent. * Pregnant women

Design outcomes

Primary

MeasureTime frameDescription
Mucosal Impedance as measured by an endoscopic probeUp to two yearsAssess the mucosal impedance of neosquamous epithelium after successful treatment of Barrett's Esophagus.

Secondary

MeasureTime frameDescription
Tissue levels of prostaglandin E2Up to two yearsAssess the levels of prostaglandin E2 in neosquamous epithelium after successful treatment of Barrett's Esophagus.
Intracellular spaceUp to two yearsAssess the intercellular space in neosquamous epithelium following successful treatment of Barrett's Esophagus with use of transmission electron microscopy.
Volumetric Laser EndomicroscopyUp to two yearsAssess and measure precise thickness of and area of subsquamous structions underneath the neosquamous epithelium.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026