Characterization of the Neo-squamous Epithelial Barrier

January 16, 2023 updated by: Prasad G. Iyer, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who have successfully completed endoscopic ablation (one endoscopy with no evidence of intestinal metaplasia).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Successfully ablated patients
Mucosal impedance will be performed at the time of clinically indicated endoscopy. Research biopsies will be obtained during clinically indicated endoscopy.
Device: 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.
Other: 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.
Device: 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.
Other: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mucosal Impedance as measured by an endoscopic probe
Time Frame: Up to two years
Assess the mucosal impedance of neosquamous epithelium after successful treatment of Barrett's Esophagus.
Up to two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue levels of prostaglandin E2
Time Frame: Up to two years
Assess the levels of prostaglandin E2 in neosquamous epithelium after successful treatment of Barrett's Esophagus.
Up to two years
Intracellular space
Time Frame: Up to two years
Assess the intercellular space in neosquamous epithelium following successful treatment of Barrett's Esophagus with use of transmission electron microscopy.
Up to two years
Volumetric Laser Endomicroscopy
Time Frame: Up to two years
Assess and measure precise thickness of and area of subsquamous structions underneath the neosquamous epithelium.
Up to two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Prasad Iyer, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2016

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

June 29, 2022

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

March 7, 2017

First Posted (Actual)

March 13, 2017

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 16, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-005490

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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