Characterization of the Neo-squamous Epithelial Barrier
- Conditions
- Barrett's Esophagus With Dysplasia
- Interventions
- Device: Mucosal ImpedanceOther: Research BiopsiesDevice: Volumetric Laser Endomicroscopy
- Registration Number
- NCT03077594
- Lead Sponsor
- Mayo Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- Adults (age 18-90) who underwent an ablative program for BE
- Patients that have not achieved complete remission of intestinal metaplasia.
- Patients unable to consent.
- Pregnant women
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Successfully ablated patients - VLE Volumetric Laser Endomicroscopy 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. Successfully ablated patients Mucosal Impedance Mucosal impedance will be performed at the time of clinically indicated endoscopy. Research biopsies will be obtained during clinically indicated endoscopy. Successfully ablated patients - VLE Research Biopsies 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. Successfully ablated patients Research Biopsies Mucosal impedance will be performed at the time of clinically indicated endoscopy. Research biopsies will be obtained during clinically indicated endoscopy. Successfully ablated patients - VLE Mucosal Impedance 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.
- Primary Outcome Measures
Name Time Method Mucosal Impedance as measured by an endoscopic probe Up to two years Assess the mucosal impedance of neosquamous epithelium after successful treatment of Barrett's Esophagus.
- Secondary Outcome Measures
Name Time Method Volumetric Laser Endomicroscopy Up to two years Assess and measure precise thickness of and area of subsquamous structions underneath the neosquamous epithelium.
Tissue levels of prostaglandin E2 Up to two years Assess the levels of prostaglandin E2 in neosquamous epithelium after successful treatment of Barrett's Esophagus.
Intracellular space Up to two years Assess the intercellular space in neosquamous epithelium following successful treatment of Barrett's Esophagus with use of transmission electron microscopy.
Trial Locations
- Locations (2)
Columbia University Medical Center
🇺🇸New York, New York, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States