Confocal Endomicroscopy for Barrett's Esophagus



Status:Completed
Conditions:Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:8/24/2018
Start Date:April 2007
End Date:September 2008

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Confocal Laser Endomicroscopy for Improved Diagnosis of Barrett's Esophagus and Associated Neoplasia

The purpose of this study is to determine if confocal laser endomicroscopy (CLE) can improve
detection of Barrett's esophagus, dysplasia, and early esophageal cancer.

Barrett's esophagus is a leading cause of esophageal adenocarcinoma. Detection of dysplasia
and early cancers in Barrett's esophagus can be challenging, time-consuming and expensive.
Small lesions may be difficult to detect with standard endoscopy protocols. Confocal laser
endomicroscopy (CLE) is a new type of endoscopy where a small confocal microscope is built
into the tip of a standard endoscope. For this study, we are comparing confocal laser
endomicroscopy (CLE) with targeted biopsies with standard endoscopy (EGD)and biopsy for
Barrett's esophagus to determine if CLE is more effective for detecting dysplasia and cancer.

Participants with Barrett's esophagus in this study undergo 1) CLE with targeted mucosal
biopsies (biopsy only taken if CLE shows abnormal tissue) and 2) standard EGD with biopsies.
The order of procedures is randomized (some patients have CLE first while others have
standard EGD first).

Inclusion Criteria:

- Barrett's esophagus or suspected Barrett's-associated neoplasia

- Age > 18

- Able to give informed consent

Exclusion Criteria:

- Known advanced malignant disease

- Allergy to the fluorescent contrast agent fluorescein sodium

- Coagulopathy or bleeding disorder
We found this trial at
1
site
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
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