Esophageal Cancer Clinical Trial

Confocal Endomicroscopy for Barrett’s Esophagus

Summary

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.

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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).

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Eligibility Criteria

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

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

46

Study ID:

NCT00487695

Recruitment Status:

Completed

Sponsor:

Johns Hopkins University

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There is 1 Location for this study

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Johns Hopkins Hospital
Baltimore Maryland, 21205, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 3

Estimated Enrollment:

46

Study ID:

NCT00487695

Recruitment Status:

Completed

Sponsor:


Johns Hopkins University

How clear is this clinincal trial information?

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