Digestive System Diseases
Conditions
Keywords
confocal, biliary, esophagus
Brief summary
The goal of the project is to determine whether confocal endomicroscopy can be used to identify and discriminate among dysplastic, neoplastic, and nonneoplastic tissue, as compared with histologic specimens as a reference. The project will evaluate those at risk for or with known Barrett's esophagus, and those with known or suspected biliary strictures. It is our hypothesis that we will be able to identify between neoplastic and nonneoplastic tissue.
Detailed description
This study was amended from it's initial design to increase the number of patients to 200. The study was terminated in July 2016 after 106 patients were enrolled and had completed the study.
Interventions
DEVICEConfocal Imaging
Confocal imaging performed of the digestive system with the use of confocal miniprobes such as the Gastroflex UHD and Cholangioflex miniprobes (Cellvizio, Mauna Kea, Paris, France)
Sponsors
Yale University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with long-standing reflux symptoms, undergoing surveillance for Barrett's esophagus, or scheduled for endoscopic therapy with esophageal dysplasia * Patients undergoing ERCP for known or suspected biliary strictures.
Exclusion criteria
* have a known allergy or have had a prior adverse reaction to fluorescent contrast agents or chromoendoscopy stains * are younger than age 18 or who are mentally or legally incapacitated or unable to give informed consent * are pregnant or breastfeeding * patients with advanced esophageal cancer * acute gastrointestinal bleeding * coagulopathy * impaired renal function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare confocal image characteristics between benign and malignant tissue. | 2 Years |
Countries
United States
Outcome results
None listed