Phase 3 Completed N=46 Randomized Diagnostic

Confocal Endomicroscopy for Barrett's Esophagus

Barrett's esophagus · Esophageal Adenocarcinoma

Source: ClinicalTrials.gov NCT00487695 ↗

Enrolled (actual)

Serious AEs

1.3%

Results posted

Aug 2011

Primary outcomePrimary: Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia) — 34; 17 percent yield for neoplasia — p=0.01

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia)	34; 17	0.01 sig
SECONDARY Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia)	3.1; 3.7	0.89
SECONDARY Mean Number of Biopsies Taken in High Risk Patients (Suspected Neoplasia)	9.8; 23.7	0.002 sig
SECONDARY Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients	0; 0	—
SECONDARY Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients	0; 0	1.0
SECONDARY Mean Number of Biopsies Taken in Barrett's Surveillance Patients	1.7; 12.6	<0.0001 sig

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00487695). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.