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Characterization of the Neo-squamous Epithelial Barrier

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Mayo Clinic

Status

Completed

Conditions

Barrett's Esophagus With Dysplasia

Treatments

Device: Volumetric Laser Endomicroscopy
Other: Research Biopsies
Device: Mucosal Impedance

Study type

Observational

Funder types

Other

Identifiers

NCT03077594
16-005490

Details and patient eligibility

About

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.

Full 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.

Enrollment

53 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

53 participants in 2 patient groups

Successfully ablated patients
Description:
Mucosal impedance will be performed at the time of clinically indicated endoscopy. Research biopsies will be obtained during clinically indicated endoscopy.
Treatment:
Other: Research Biopsies
Device: Mucosal Impedance
Successfully ablated patients - VLE
Description:
Mucosal impedance will be performed at the time of clinically indicated endoscopy. Research biopsies will be obtained during clinically indicated endoscopy. Volumetric laser endomicroscopy (VLE) will be done.
Treatment:
Device: Volumetric Laser Endomicroscopy
Other: Research Biopsies
Device: Mucosal Impedance

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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