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Status unknownNCT03228407Updated Jan 16, 2018

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

An interventional study of Confocal endomicroscopy and Endoscopic biopsies in Gastro Esophageal Reflux, Barrett Esophagus and Erosive Esophagitis, sponsored by McGuire Research Institute. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-16.

Sponsored by McGuire Research Institute · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Gastro Esophageal Reflux
  • Barrett Esophagus
  • Erosive Esophagitis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (estimated)

Study arms

  • 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 · Diagnostic Test: Endoscopic biopsies · Diagnostic Test: Mucosal impedance (MI)

  • 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 · Diagnostic Test: Endoscopic biopsies · Diagnostic Test: Mucosal impedance (MI)

  • 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 · Diagnostic Test: Endoscopic biopsies · Diagnostic Test: Mucosal impedance (MI)

Interventions

  • ProcedureConfocal 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.

    Also known as: cellvizio

  • Diagnostic testEndoscopic 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 testMucosal 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.

05

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

06

Study locations

1 of 1 sites recruiting
  • Hunter Holmes McGuire VA Medical Center
    Richmond, Virginia 23249, United States
    • Pritesh R Pritesh, MD,MPH · Contact · pritesh.mutha@va.gov · 804-675-5000
    • Pritesh R Pritesh, MD,MPH · Principal investigator
    • Tilak Shah, MD · Sub investigator
    • Mitchell Schubert, MD · Sub investigator
    • Alvin Zfass, MD · Sub investigator
    Recruiting
07

References and documents

Publications

  • Vaezi MF, Choksi Y. Mucosal Impedance: A New Way To Diagnose Reflux Disease and How It Could Change Your Practice. Am J Gastroenterol. 2017 Jan;112(1):4-7. doi: 10.1038/ajg.2016.513. Epub 2016 Dec 13. No abstract available. PubMed 27958288 ↗
  • Cui R, Zhou L, Lin S, Xue Y, Duan L, Xia Z, Jin Z, Zhang H, Zhang J, Song Z, Yan X. The feasibility of light microscopic measurements of intercellular spaces in squamous epithelium in the lower-esophagus of GERD patients. Dis Esophagus. 2011 Jan;24(1):1-5. doi: 10.1111/j.1442-2050.2010.01083.x. PubMed 20626453 ↗
  • Tobey NA, Carson JL, Alkiek RA, Orlando RC. Dilated intercellular spaces: a morphological feature of acid reflux--damaged human esophageal epithelium. Gastroenterology. 1996 Nov;111(5):1200-5. doi: 10.1053/gast.1996.v111.pm8898633. PubMed 8898633 ↗
  • Chu CL, Zhen YB, Lv GP, Li CQ, Li Z, Qi QQ, Gu XM, Yu T, Zhang TG, Zhou CJ, Rui-Ji, Li YQ. Microalterations of esophagus in patients with non-erosive reflux disease: in-vivo diagnosis by confocal laser endomicroscopy and its relationship with gastroesophageal reflux. Am J Gastroenterol. 2012 Jun;107(6):864-74. doi: 10.1038/ajg.2012.44. Epub 2012 Mar 13. PubMed 22415199 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03228407
Lead sponsor
McGuire Research Institute
Collaborators
Hunter Holmes McGuire VA Medical Center
Responsible party
Sponsor
First posted
Jul 24, 2017
Start date
Apr 28, 2017
Primary completion
Jun 2018 (estimated)
Completion
Jun 2018 (estimated)
Last update
Jan 16, 2018

Study contacts

Pritesh R Mutha, MD,MPH
Contact
pritesh.mutha@va.gov
804-675-5000 ext. 5021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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