A Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Esophageal Confocal Imaging	Confocal Imaging	-
Biliary Confocal Imaging	Confocal Imaging	-

Primary Outcome Measures

Name	Time	Method
To compare confocal image characteristics between benign and malignant tissue.	2 Years

Secondary Outcome Measures

Name	Time	Method

Locations (1): Yale New Haven Hospital
🇺🇸
New Haven, Connecticut, United States

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