Barrett Syndrome, Barrett's Syndrome, Barrett's Esophagus, Barrett Esophagus, Adenocarcinoma
Conditions
Keywords
Barrett's Esophagus, EsoGastroDuodenoscopy, Barrett's Carcinoma, adenocarcinoma, Cellvizio, endomicroscopy, random biopsy
Brief summary
This study will collect data from patients routinely undergoing a endoscopic surveillance and Cellvizio endomicroscopy procedure due to confirmed Barrett's esophagus. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.
Detailed description
This is a longitudinal observational study were imaging procedures are allocated in a random order to directly address the low sensitivity and specificity of enhanced macroscopic endoscopic imaging devices by determining whether probe-based Confocal Laser Endomicroscopy (pCLE), as a supplement to Narrow Band Imaging (NBI) can further improve sensitivity and specificity to a level that would be acceptable to avoid random biopsy, and better direct biopsy of suspicious areas. The study is also addressing pCLE as a supplement to standard white light endoscopy and random biopsy alone. In fact, the study is powered to evaluate per lesion sensitivity and specificity of confocal imaging as applied to lesions identified by white light endoscopy. Therefore, the study addresses the shortcomings of standard white light endoscopy (high number of random biopsies, less than ideal directed biopsy of suspicious areas) and the primary shortcomings of Narrow Band Imaging (NBI) (low specificity with resultant high false positives, again resulting in many unnecessary biopsies).
Interventions
DEVICEImaging procedures (NBI)
Imaging procedures (pCLE) and (NBI) - All patients undergo both procedures back to back by two endoscopists, blinded to each other, in randomized order. Procedure 1: Standard endoscopic procedure The patient receives white light endoscopy (WLE) examination. All visible lesions are noted and photographed. No biopsy is taken until both procedures are complete. Procedure 2: NBI endoscopic procedure The patient receives a NBI endoscopy examination. All visible and NBI abnormal lesions are noted and photographed. After both procedures are complete and all sites are unblinded to both endoscopists. pCLE with Cellvizio and physical biopsies are performed at all sites plus 4 quadrant sites.
DEVICEHDWLE
DEVICEpCLE
Sponsors
Cellvizio Inc.
Emissary International LLC
Mauna Kea Technologies
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with documented or suspected Barrett's esophagus presenting for endoscopy 2. Age \> 18 years 3. Ability to provide written, informed consent
Exclusion criteria
1. Presence of erosive esophagitis 2. Inability to obtain biopsies due to anticoagulation, varices, etc. 3. Allergy to fluorescein, pregnancy 4. Presence of an esophageal mass other than small 10mm or less nodules 5. Renal insufficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. | Centralized histopathology confirmation within 4-6 weeks | Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. |
Countries
France, Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 NBI-pCLE | 101 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Tissue sampling incomplete/conclusive | 8 | 13 |
Baseline characteristics
| Characteristic | Group 1 |
|---|---|
| Age, Continuous | 65.1 years STANDARD_DEVIATION 11.52 |
| Region of Enrollment France | 9 participants |
| Region of Enrollment Germany | 30 participants |
| Region of Enrollment United States | 62 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 122 |
| serious Total, serious adverse events | 0 / 122 |
Outcome results
Primary
Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.
Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.
Time frame: Centralized histopathology confirmation within 4-6 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HDWLE | Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. | Sensitivity | 34.2 percentage of lesions |
| HDWLE | Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. | Specificity | 92.7 percentage of lesions |
| NBI (Narrow Band Imaging) | Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. | Sensitivity | 41.7 percentage of lesions |
| NBI (Narrow Band Imaging) | Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. | Specificity | 90.5 percentage of lesions |
| pCLE | Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. | Sensitivity | 62.5 percentage of lesions |
| pCLE | Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. | Specificity | 92.7 percentage of lesions |
| HDWLE+NBI+pCLE | Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. | Sensitivity | 75.8 percentage of lesions |
| HDWLE+NBI+pCLE | Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. | Specificity | 84.2 percentage of lesions |
| HDWLE+pCLE | Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. | Sensitivity | 68.3 percentage of lesions |
| HDWLE+pCLE | Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. | Specificity | 87.8 percentage of lesions |
| HDWLE+NBI | Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. | Sensitivity | 45.0 percentage of lesions |
| HDWLE+NBI | Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. | Specificity | 88.2 percentage of lesions |