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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biliary Confocal Imaging |
| ||
| Esophageal Confocal Imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Confocal Imaging | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| To compare confocal image characteristics between benign and malignant tissue. | 2 Years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with long-standing reflux symptoms, undergoing surveillance for Barrett's esophagus, or scheduled for endoscopic therapy with esophageal dysplasia. Also, patients undergoing ERCP for known or suspected biliary strictures.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Nathanson, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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