Characterization of the Neo-squamous Epithelial Barrier
NCT ID: NCT03077594
Last Updated: 2023-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
53 participants
OBSERVATIONAL
2016-09-26
2022-06-29
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Successfully ablated patients
Mucosal impedance will be performed at the time of clinically indicated endoscopy. Research biopsies will be obtained during clinically indicated endoscopy.
Mucosal Impedance
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.
Research Biopsies
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.
Successfully ablated patients - VLE
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.
Mucosal Impedance
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.
Research Biopsies
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.
Volumetric 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.
Interventions
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Mucosal Impedance
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.
Research Biopsies
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.
Volumetric 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients unable to consent.
* Pregnant women
18 Years
90 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Prasad G. Iyer
MD
Principal Investigators
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Prasad Iyer, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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16-005490
Identifier Type: -
Identifier Source: org_study_id
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