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

McGuire Research Institute

Status: Unknown

Conditions: Erosive Esophagitis; Gastro Esophageal Reflux; Barrett Esophagus

Treatments: Diagnostic Test: Mucosal impedance (MI); Diagnostic Test: Endoscopic biopsies; Procedure: Confocal endomicroscopy

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03228407

2282

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 3 patient groups, including a placebo group

Non-erosive reflux disease (NERD)

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Mucosal impedance (MI)

Diagnostic Test: Endoscopic biopsies

Procedure: Confocal endomicroscopy

Barrett's esophagus/erosive esophagitis

Active Comparator group

Description:

Patient's with Barrett's esophagus or with erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed.

Treatment:

Diagnostic Test: Mucosal impedance (MI)

Diagnostic Test: Endoscopic biopsies

Procedure: Confocal endomicroscopy

Control

Placebo Comparator group

Description:

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.

Treatment:

Diagnostic Test: Mucosal impedance (MI)

Diagnostic Test: Endoscopic biopsies

Procedure: Confocal endomicroscopy