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

NCT ID: NCT02366039

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 76 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2023-08-10

Brief Summary

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

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.

Conditions

Barrett's Esophagus With High Grade Dsyplasia; Early Esophageal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

EMR

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

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Cadman Leggett

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cadman Leggett, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

12-006665

Identifier Type: -

Identifier Source: org_study_id