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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Digestive System Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Biliary Confocal Imaging

Confocal Imaging

Intervention Type 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)

Esophageal Confocal Imaging

Confocal Imaging

Intervention Type 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)

Interventions

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Confocal 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)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No