Probe-based Volumetric Laser Endomicroscopy (pVLE) of Endoscopic Mucosal Resection (EMR) Tissue in Patients With Barrett's Dysplasia (VLE EMR)

This study is to assess the diagnostic accuracy and precision of the Probe-based Volumetric Laser Endomicroscopy (pVLE) imaging system in detecting dysplasia in BE in both in vivo and ex vivo imaging of Endoscopic Mucosal Resection (EMR) tissue, as compared to standard histopathology

Study Overview

• Status: Completed
• Conditions: Barrett's Esophagus With High Grade Dsyplasia; Early Esophageal Cancer

Detailed Description

To assess the ability of pVLE to visualize subsurface architecture of EMR tissue, as compared to histology in both in vivo and ex vivo imaging.

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

subjects undergoing clinically-indicated EMR for BE dysplasia will be invited to participate

Description

Inclusion Criteria:

1. Males and females over the age of 18 years.
2. Patients with either suspected or confirmed Barrett's-associated high grade dysplasia (HGD) or intramucosal cancer (IMC) presenting for endoscopy possibly requiring EMR.
3. Ability to provide written, informed consent.
4. Females must be willing to take a pregnancy test if still capable of bearing a child.

Exclusion Criteria:

1. Patients on anticoagulation undergoing high risk procedures in accordance to ASGE guideline for the management of antithrombotic agents for endoscopic procedures (2009)*.
2. Patients with esophageal varices that preclude biopsies.
3. Presence of an esophageal mass/cancer that precludes full distention of the balloon from the Nvision balloon guide sheath.
4. Patients with esophageal strictures that would prevent adequate expansion of the balloon from the Nvision guide sheath.
5. Patients with known inflammatory disease, esophageal tears or ulcers, which prohibit full distention of the balloon from the Nvision balloon guide sheath.
6. Patients with known eosinophilic esophagitis.
7. Patients who are pregnant.

8. Patients with a history of hemostasis disorders*.

   • Patients on anticoagulation undergoing low risk procedures are not excluded. ** Hemostasis disorders will include, but will not be limited to: patients with hemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (<100,000 plt/ul) and individuals with von Willebrand's disease or other known platelet malfunction disorders.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
EMR; patients undergoing clinically indicated endoscopic mucosal resection as standard of care will be asked to participate for this observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
distinguishing between normal esophageal squamous mucosa and Barrett's dysplasia	We will assess descriptive and diagnostic performance (accuracy, sensitivity, specificity, positive and negative predictive values) of the Nvision pVLE device in visualizing dysplasia as compared to standard histopathology	at time of endoscopic mucosal resection

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Fred Hutchinson Cancer Center
• Investigators: Principal Investigator: Cadman Leggett, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: February 11, 2015
• First Submitted That Met QC Criteria: February 18, 2015
• First Posted (Estimated): February 19, 2015

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: 12-006665

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No