Clinical trial NCT02852525: Confocal Laser Probe to Treat Barrett's Esophagus
Official title: Real-Time Evaluation of Barrett's Esophagus by Confocal Laser Probe-based Microscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett's Esophagus
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 29
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to further validate the use of probe-based confocal laser endomicroscopy (pCLE) for the evaluation of Barrett's Esophagus and associated neoplasia in a larger patient base.

Detailed description: Subject Population

Approximately 100 subjects will be recruited, age greater than 18 years. Subjects will be recruited from OCF, OMC Kenner who are undergoing EGD for either 1) screening for Barrett's Esophagus because of long-standing GERD of greater than 5 years; 2) surveillance of known Barrett's Esophagus; or 3) therapy for known Barrett's Esophagus. They will be asked to volunteer for participation at the time of their EGD. These subjects are being recruited because of a high suspicion or known diagnosis of Barrett's Esophagus in this cohort.

Procedures

Patients agreeing to participate in the research study will receive an additional intravenous injection during endoscopy. This dose of 2.5 mg of IV fluorescein will be administered during their EGD. Probe-based microscopy will be used to evaluate the mucosa of the esophagus and GE junction. Photographs will be taken and digitally stored. Biopsies (which are part of the routine diagnosis and surveillance of Barrett's) will be targeted based on the microscopic images. The histologic findings on the biopsy specimens will be compared to the microscopic images to determine the accuracy of the probe-based microscopy in predicting pathology.

The time commitment for the patient is included in the time to undergo endoscopy and is roughly 30 minutes to an hour, including recovery time. The research will occur at OMC, Jefferson Highway and Ochsner Medical Center, Kenner.

Eligibility criteria: Inclusion Criteria:

* Must be greater than 18 years of age
* currently undergoing EGD
* previous diagnosis of Barrett's Esophagus
* long-standing GERD of greater than 5 years
* undergoing therapy for previously diagnosed Barrett's Esophagus

Exclusion Criteria:

* Under 19 years of age

Primary outcomes:
measure: Sensitivity and Specificity of probe based endomicroscopy as compared to histopathology in diagnosing Barrett's metaplasia
timeFrame: 30 minutes up to an hour on average after undergoing endoscopy
Secondary outcomes:
measure: Tissue and blood Biomarker evaluation in targeted biopsies obtained at endomicroscopy in patients diagnosed to have Barrett's metaplasia and dysplasia
timeFrame: 30 minutes up to an hour on average after undergoing endoscopy
Other outcomes:
Locations:
city: Kenner
country: United States
facility: Oschsner Medical Center-Kenner
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Medical Center-Jefferson Highway
state: Louisiana
Study officials:
affiliation: Ochsner Health System
name: Virendra Joshi, MD
role: PRINCIPAL_INVESTIGATOR
References: