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

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ClinicalTrials.gov Identifier: NCT01262937
Recruitment Status : Terminated
First Posted : December 20, 2010
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment
Digestive System Diseases Device: Confocal Imaging

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.

Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study to Examine the Human Gastrointestinal Tract Using the Confocal Endomicroscope
Actual Study Start Date : July 2009
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Biliary Confocal Imaging Device: 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)

Esophageal Confocal Imaging Device: 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)




Primary Outcome Measures :
  1. To compare confocal image characteristics between benign and malignant tissue. [ Time Frame: 2 Years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262937


Locations
United States, Connecticut
Yale New Haven Hospital
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Michael Nathanson, MD, PhD Yale University

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01262937     History of Changes
Other Study ID Numbers: 0706002810
First Posted: December 20, 2010    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018

Keywords provided by Yale University:
confocal, biliary, esophagus

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases