Phase 3
N=46
Confocal Endomicroscopy for Barrett's Esophagus
Barrett's Esophagus · Esophageal Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00487695 ↗Enrolled (actual)
46
Serious AEs
1.3%
Results posted
Aug 2011
Primary outcome: Primary: Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia) — 34; 17 percent yield for neoplasia — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- confocal laser endomicroscopy (CLE) (Device); standard endoscopy (EGD) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- May 2008
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 |
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.
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
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.