Clinical trial NCT03228407: Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)
Official title: Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastro Esophageal Reflux
Barrett Esophagus
Erosive Esophagitis
Lead sponsor: McGuire Research Institute
Sponsor class: OTHER
Collaborators: name: Hunter Holmes McGuire VA Medical Center
First posted: 2017-07-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: 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
timeFrame: Through study completion, an average of 1 year.
measure: 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
timeFrame: Through study completion, an average of 1 year.
measure: Correlation between the Ussing's chamber findings (esophageal permeability) and confocal endomicroscopy findings of patients with symptoms of refractory GERD and Barrett's esophagus
timeFrame: Through study completion, an average of 1 year.
measure: Correlation between the Ussing's chamber findings (esophageal permeability) and confocal endomicroscopy findings of patients with symptoms of refractory GERD and controls
timeFrame: Through study completion, an average of 1 year.
measure: Correlation between the Ussing's chamber findings (esophageal permeability) and Mucosal impedance findings of patients with symptoms of refractory GERD and controls
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
Study officials:
References:
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. No abstract available.
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. doi: 10.1111/j.1442-2050.2010.01083.x.
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. doi: 10.1053/gast.1996.v111.pm8898633.
citation: 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.