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

NCT01262937 | Terminated

• 1 other identifier: 0706002810
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Digestive System Diseases

Keywords

confocal, biliary, esophagus

Outcome Measures

Primary Outcomes (1)

• To compare confocal image characteristics between benign and malignant tissue.

  2 Years

Study Arms (2)

Biliary Confocal Imaging

Device: Confocal Imaging

Esophageal Confocal Imaging

Device: Confocal Imaging

Interventions

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)

Biliary Confocal Imaging; Esophageal Confocal Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Digestive System Diseases

Study Officials

• Michael Nathanson, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 20, 2010
• Study Start: July 1, 2009
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 26, 2018

Record last verified: 2018-02

Locations

US (1)