Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)

January 11, 2018 updated by: McGuire Research Institute
Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Recruiting
        • Hunter Holmes McGuire VA Medical Center
        • Contact:
        • Principal Investigator:
          • Pritesh R Pritesh, MD,MPH
        • Sub-Investigator:
          • Tilak Shah, MD
        • Sub-Investigator:
          • Mitchell Schubert, MD
        • Sub-Investigator:
          • Alvin Zfass, MD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age > 18 years
  2. Ability to give informed consent

Exclusion Criteria:

  1. Pregnancy
  2. Esophageal varices
  3. Prior esophageal or gastric surgery
  4. Active gastrointestinal bleeding
  5. Evidence of esophageal malignancy
  6. Inability to provide informed consent

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Non-erosive reflux disease (NERD)
Patient's with GERD refractory to PPI with no evidence of erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.
Procedure: Confocal endomicroscopy
Confocal laser endomicroscopy (CLE) permits real-time in-vivo histologic analysis of esophageal mucosa at the time of upper endoscopy. The technology is based on the principle of illuminating a tissue with a low-power laser and then detecting fluorescent light reflected from the tissue. Because CLE relies upon tissue fluorescence, intravenous fluorescein is generally used to highlight the vasculature and intercellular spaces of the tissue being examined.
Other Names:
  • cellvizio
Diagnostic test: Endoscopic biopsies
Additional biopsies will be obtained of the esophageal mucosa.These will be obtained with a standard biopsy forceps inserted through the channel in gastroscope.
Diagnostic test: Mucosal impedance (MI)
MI balloon measures epithelial impedance along a 10 cm length of esophagus. The gastroscope will be withdrawn and the MI balloon will be advanced into the esophagus through the mouth. The balloon will be inflated so that the sensors contact the esophageal mucosa. After MI measurements are obtained, the balloon will be deflated and withdrawn.
Active Comparator: Barrett's esophagus/erosive esophagitis
Patient's with Barrett's esophagus or with erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.
Procedure: Confocal endomicroscopy
Confocal laser endomicroscopy (CLE) permits real-time in-vivo histologic analysis of esophageal mucosa at the time of upper endoscopy. The technology is based on the principle of illuminating a tissue with a low-power laser and then detecting fluorescent light reflected from the tissue. Because CLE relies upon tissue fluorescence, intravenous fluorescein is generally used to highlight the vasculature and intercellular spaces of the tissue being examined.
Other Names:
  • cellvizio
Diagnostic test: Endoscopic biopsies
Additional biopsies will be obtained of the esophageal mucosa.These will be obtained with a standard biopsy forceps inserted through the channel in gastroscope.
Diagnostic test: Mucosal impedance (MI)
MI balloon measures epithelial impedance along a 10 cm length of esophagus. The gastroscope will be withdrawn and the MI balloon will be advanced into the esophagus through the mouth. The balloon will be inflated so that the sensors contact the esophageal mucosa. After MI measurements are obtained, the balloon will be deflated and withdrawn.
Placebo Comparator: Control
Patient's with no h/o GERD or Barrett's esophagus who are undergoing endoscopy for non-GERD related indication. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.
Procedure: Confocal endomicroscopy
Confocal laser endomicroscopy (CLE) permits real-time in-vivo histologic analysis of esophageal mucosa at the time of upper endoscopy. The technology is based on the principle of illuminating a tissue with a low-power laser and then detecting fluorescent light reflected from the tissue. Because CLE relies upon tissue fluorescence, intravenous fluorescein is generally used to highlight the vasculature and intercellular spaces of the tissue being examined.
Other Names:
  • cellvizio
Diagnostic test: Endoscopic biopsies
Additional biopsies will be obtained of the esophageal mucosa.These will be obtained with a standard biopsy forceps inserted through the channel in gastroscope.
Diagnostic test: Mucosal impedance (MI)
MI balloon measures epithelial impedance along a 10 cm length of esophagus. The gastroscope will be withdrawn and the MI balloon will be advanced into the esophagus through the mouth. The balloon will be inflated so that the sensors contact the esophageal mucosa. After MI measurements are obtained, the balloon will be deflated and withdrawn.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between the time from intravenous injection of fluorescein to visualization of fluorescein on probe based confocal endomicroscopy (pCLE) with esophageal permeability (i.e. - epithelial barrier function).
Time Frame: Through study completion, an average of 1 year.
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare the time from intravenous injection of fluorescein to visualization of fluorescein on probe based confocal endomicroscopy (pCLE) in patients with Barrett's esophagus and controls
Time Frame: Through study completion, an average of 1 year.
Through study completion, an average of 1 year.
Compare the time from intravenous injection of fluorescein to visualization of fluorescein on probe based confocal endomicroscopy (pCLE) in patients with symptoms of refractory GERD and Barrett's esophagus
Time Frame: Through study completion, an average of 1 year.
Through study completion, an average of 1 year.
Correlation between the Ussing's chamber findings (esophageal permeability) and confocal endomicroscopy findings of patients with symptoms of refractory GERD and Barrett's esophagus
Time Frame: Through study completion, an average of 1 year.
Through study completion, an average of 1 year.
Correlation between the Ussing's chamber findings (esophageal permeability) and confocal endomicroscopy findings of patients with symptoms of refractory GERD and controls
Time Frame: Through study completion, an average of 1 year.
Through study completion, an average of 1 year.
Correlation between the Ussing's chamber findings (esophageal permeability) and Mucosal impedance findings of patients with symptoms of refractory GERD and controls
Time Frame: Through study completion, an average of 1 year.
Through study completion, an average of 1 year.

Collaborators and Investigators

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

Sponsor

McGuire Research Institute

Collaborators

Hunter Holmes McGuire VA Medical Center

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.

General Publications

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)

April 28, 2017

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

July 6, 2017

First Submitted That Met QC Criteria

July 20, 2017

First Posted (Actual)

July 24, 2017

Study Record Updates

Last Update Posted (Actual)

January 16, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2282

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

Yes

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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