Clinical trial NCT00795184: Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy
Official title: Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett Syndrome
Barrett's Syndrome
Barrett's Esophagus
Barrett Esophagus
Adenocarcinoma
Keywords: Barrett's Esophagus
EsoGastroDuodenoscopy
Barrett's Carcinoma
adenocarcinoma
Cellvizio
endomicroscopy
random biopsy
Lead sponsor: Mauna Kea Technologies
Sponsor class: INDUSTRY
Collaborators: name: Cellvizio Inc.
name: Emissary International LLC
First posted: 2008-11-21
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Centralized histopathology confirmation within 4-6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Kansas City
country: United States
facility: Veterans Affairs Hospital
state: Missouri
city: New York
country: United States
facility: New York Presbyterian Hospital/Columbia University Medical Center
state: New York
city: Nantes
country: France
facility: Centre Hospitalier Universitaire
city: Munich
country: Germany
facility: Klinikum rechts der Isar
state: Bayern
Study officials:
affiliation: Veterans Affairs Hospital, Kansas City
name: Prateek Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.