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

Not Applicable

• Conditions: Gastro Esophageal Reflux; Barrett Esophagus; Erosive Esophagitis
• Interventions: Procedure: Confocal endomicroscopy; Diagnostic Test: Endoscopic biopsies; Diagnostic Test: Mucosal impedance (MI)

• Registration Number: NCT03228407
• Lead Sponsor: McGuire Research Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-28
• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-24
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-11
• Last Update Posted: 2018-01-16
• Primary Completion: 2018-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Mucosal impedance (MI)	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.
Non-erosive reflux disease (NERD)	Confocal endomicroscopy	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.
Barrett's esophagus/erosive esophagitis	Confocal endomicroscopy	Patient's with Barrett's esophagus or with erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.
Non-erosive reflux disease (NERD)	Endoscopic biopsies	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.
Non-erosive reflux disease (NERD)	Mucosal impedance (MI)	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.
Control	Endoscopic biopsies	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.
Barrett's esophagus/erosive esophagitis	Endoscopic biopsies	Patient's with Barrett's esophagus or with erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.
Barrett's esophagus/erosive esophagitis	Mucosal impedance (MI)	Patient's with Barrett's esophagus or with erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.
Control	Confocal endomicroscopy	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hunter Holmes McGuire VA Medical Center; 🇺🇸 Richmond, Virginia, United States