Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy

Not Applicable

Completed

• Conditions: Barrett Esophagus; Barrett Syndrome; Barrett's Esophagus; Barrett's Syndrome; Adenocarcinoma
• Interventions: Device: Imaging procedures (NBI); Device: HDWLE; Device: pCLE

• Registration Number: NCT00795184
• Lead Sponsor: Mauna Kea Technologies

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).

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Primary Completion: 2009-09
• Study Completion: 2010-02
• Results First Submitted: 2012-06-04
• Status Verified: 2016-05
• Results First Submitted QC: 2016-05-02
• Last Update Submitted: 2016-05-02
• Results First Posted: 2016-05-03
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Imaging Procedures NBI first HDWLE second and pCLE	HDWLE	All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.
Imaging Procedures HDWLE first NBI second and pCLE	Imaging procedures (NBI)	All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.
Imaging Procedures HDWLE first NBI second and pCLE	HDWLE	All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.
Imaging Procedures HDWLE first NBI second and pCLE	pCLE	All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.
Imaging Procedures NBI first HDWLE second and pCLE	Imaging procedures (NBI)	All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.
Imaging Procedures NBI first HDWLE second and pCLE	pCLE	All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

Centre Hospitalier Universitaire; 🇫🇷 Nantes, France

Veterans Affairs Hospital; 🇺🇸 Kansas City, Missouri, United States

New York Presbyterian Hospital/Columbia University Medical Center; 🇺🇸 New York, New York, United States

Klinikum rechts der Isar; 🇩🇪 Munich, Bayern, Germany

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States