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

Barrett Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03228407
• Other study ID #: 2282
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2017
• Last updated: January 11, 2018
• Start date: April 28, 2017
• Est. completion date: June 2018

Study information

• Verified date: January 2018
• Source: McGuire Research Institute
• Contact: Pritesh R Mutha, MD,MPH
• Phone: 804-675-5000
• Email: pritesh.mutha[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Erosive Esophagitis
• Esophagitis
• Gastro Esophageal Reflux
• Gastroesophageal Reflux

Intervention

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.

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.
• 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 The gastroscope will be withdrawn and the MI balloon will be advanced into the esophagus through the mouth.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.

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
McGuire Research Institute	Hunter Holmes McGuire VA Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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 gastroesopha — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.