Clinical trial NCT00487695: Confocal Endomicroscopy for Barrett's Esophagus
Official title: Confocal Laser Endomicroscopy for Improved Diagnosis of Barrett's Esophagus and Associated Neoplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Barrett's Esophagus
Esophageal Adenocarcinoma
Keywords: Barrett's esophagus
Esophageal adenocarcinoma
Endoscopy
Confocal laser endomicroscopy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: American Society for Gastrointestinal Endoscopy
name: Pentax, USA
First posted: 2007-06-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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).

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

Primary outcomes:
measure: Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia)
timeFrame: 6 weeks
Secondary outcomes:
measure: Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia)
timeFrame: 6 weeks
measure: Mean Number of Biopsies Taken in High Risk Patients (Suspected Neoplasia)
timeFrame: 6 weeks
measure: Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients
timeFrame: 6 weeks
measure: Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients
timeFrame: 6 weeks
measure: Mean Number of Biopsies Taken in Barrett's Surveillance Patients
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Division of Gastroenterology, Johns Hopkins University School of Medicine
name: Marcia I Canto, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dunbar KB, Okolo P 3rd, Montgomery E, Canto MI. Confocal laser endomicroscopy in Barrett's esophagus and endoscopically inapparent Barrett's neoplasia: a prospective, randomized, double-blind, controlled, crossover trial. Gastrointest Endosc. 2009 Oct;70(4):645-54. doi: 10.1016/j.gie.2009.02.009. Epub 2009 Jun 25.