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

Phase 3
18 Years
Not Enrolling
Barrett's Esophagus, Esophageal Adenocarcinoma

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Trial Information

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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia)

Outcome Description:

The yield for neoplasia is calculated by the number of biopsies showing neoplasia over the total number of biopsies taken (normal + neoplastic biopsies)

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Marcia I Canto, MD, MHS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Division of Gastroenterology, Johns Hopkins University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

April 2007

Completion Date:

September 2008

Related Keywords:

  • Barrett's Esophagus
  • Esophageal Adenocarcinoma
  • Barrett's esophagus
  • Esophageal adenocarcinoma
  • Endoscopy
  • Confocal laser endomicroscopy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Barrett Esophagus
  • Esophageal Diseases



Johns Hopkins HospitalBaltimore, Maryland  21287