Confocal Endomicroscopy for Barrett's Esophagus (CEBE)

Johns Hopkins University

Status and phase: Completed; Phase 3

Conditions: Esophageal Adenocarcinoma; Barrett's Esophagus

Treatments: Device: standard endoscopy (EGD); Device: confocal laser endomicroscopy (CLE)

Study type: Interventional

Funder types: Other

Identifiers

NCT00487695

NA0002805

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

46 participants in 2 patient groups

CLE followed by standard EGD

Active Comparator group

Description:

Participants are randomized to have either confocal laser endomicroscopy (CLE) or standard endoscopy (EGD) first. Then 6 weeks later, they have the other procedure. This arm is for patients randomized to CLE followed by standard EGD

Treatment:

Device: confocal laser endomicroscopy (CLE)

Device: standard endoscopy (EGD)

standard EGD followed by CLE

Active Comparator group

Description:

Patients are randomized to either have standard endoscopy (EGD)or confocal laser endomicroscopy (CLE) first. The second procedure is then completed 6 weeks later. This arm is for patients who had standard endoscopy first.

Treatment:

Device: confocal laser endomicroscopy (CLE)

Device: standard endoscopy (EGD)