Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy
DONTBIOPCE
1 other identifier
interventional
122
3 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2008
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 20, 2008
CompletedFirst Posted
Study publicly available on registry
November 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
May 3, 2016
CompletedMay 3, 2016
May 1, 2016
10 months
November 20, 2008
June 4, 2012
May 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Centralized histopathology confirmation within 4-6 weeks
Study Arms (2)
Imaging Procedures HDWLE first NBI second and pCLE
OTHERAll 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
OTHERAll 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients with documented or suspected Barrett's esophagus presenting for endoscopy
- Age \> 18 years
- Ability to provide written, informed consent
You may not qualify if:
- Presence of erosive esophagitis
- Inability to obtain biopsies due to anticoagulation, varices, etc.
- Allergy to fluorescein, pregnancy
- Presence of an esophageal mass other than small 10mm or less nodules
- Renal insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mauna Kea Technologieslead
- Cellvizio Inc.collaborator
- Emissary International LLCcollaborator
Study Sites (5)
Mayo Clinic
Jacksonville, Florida, 32224, United States
Veterans Affairs Hospital
Kansas City, Missouri, 64128, United States
New York Presbyterian Hospital/Columbia University Medical Center
New York, New York, 10032, United States
Centre Hospitalier Universitaire
Nantes, 44093 Cedex 1, France
Klinikum rechts der Isar
Munich, Bavaria, Germany
Related Publications (1)
Sharma P, Meining AR, Coron E, Lightdale CJ, Wolfsen HC, Bansal A, Bajbouj M, Galmiche JP, Abrams JA, Rastogi A, Gupta N, Michalek JE, Lauwers GY, Wallace MB. Real-time increased detection of neoplastic tissue in Barrett's esophagus with probe-based confocal laser endomicroscopy: final results of an international multicenter, prospective, randomized, controlled trial. Gastrointest Endosc. 2011 Sep;74(3):465-72. doi: 10.1016/j.gie.2011.04.004. Epub 2011 Jul 13.
PMID: 21741642RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Christophe Bailleul
- Organization
- Mauna Kea Technologies
Study Officials
- PRINCIPAL INVESTIGATOR
Prateek Sharma, MD
Veterans Affairs Hospital, Kansas City
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2008
First Posted
November 21, 2008
Study Start
November 1, 2008
Primary Completion
September 1, 2009
Study Completion
February 1, 2010
Last Updated
May 3, 2016
Results First Posted
May 3, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share