NCT03228407

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 16, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

July 6, 2017

Last Update Submit

January 11, 2018

Conditions

Gastro Esophageal RefluxBarrett EsophagusErosive Esophagitis

Outcome Measures

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).

    Through study completion, an average of 1 year.

Secondary Outcomes (5)

  • 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

    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

    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

    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

    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

    Through study completion, an average of 1 year.

Study Arms (3)

Non-erosive reflux disease (NERD)

ACTIVE COMPARATOR

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 endomicroscopyDiagnostic Test: Endoscopic biopsiesDiagnostic Test: Mucosal impedance (MI)

Barrett's esophagus/erosive esophagitis

ACTIVE COMPARATOR

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 endomicroscopyDiagnostic Test: Endoscopic biopsiesDiagnostic Test: Mucosal impedance (MI)

Control

PLACEBO COMPARATOR

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 endomicroscopyDiagnostic Test: Endoscopic biopsiesDiagnostic Test: Mucosal impedance (MI)

Interventions

Confocal endomicroscopyPROCEDURE

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
Barrett's esophagus/erosive esophagitisControlNon-erosive reflux disease (NERD)
Endoscopic biopsiesDIAGNOSTIC_TEST

Additional biopsies will be obtained of the esophageal mucosa.These will be obtained with a standard biopsy forceps inserted through the channel in gastroscope.

Barrett's esophagus/erosive esophagitisControlNon-erosive reflux disease (NERD)
Mucosal impedance (MI)DIAGNOSTIC_TEST

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.

Barrett's esophagus/erosive esophagitisControlNon-erosive reflux disease (NERD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Ability to give informed consent

You may not qualify if:

  • Pregnancy
  • Esophageal varices
  • Prior esophageal or gastric surgery
  • Active gastrointestinal bleeding
  • Evidence of esophageal malignancy
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

RECRUITING

Related Publications (4)

  • 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.

    PMID: 27958288BACKGROUND

  • 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.

    PMID: 20626453RESULT

  • 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.

    PMID: 8898633RESULT

  • 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.

    PMID: 22415199RESULT

MeSH Terms

Conditions

Gastroesophageal RefluxBarrett Esophagus

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPrecancerous ConditionsNeoplasms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Central Study Contacts

Pritesh R Mutha, MD,MPH

CONTACT

804-675-5000pritesh.mutha@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Investigator in the lab performing Ussing's chamber analysis will be blinded to the diagnosis of the patient
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2017

First Posted

July 24, 2017

Study Start

April 28, 2017

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

January 16, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)