Clinical trial NCT02366039: Probe-based Volumetric Laser Endomicroscopy (pVLE) of Endoscopic Mucosal Resection (EMR) Tissue in Patients With Barrett's Dysplasia
Official title: Probe-based Volumetric Laser Endomicroscopy (pVLE) of Endoscopic Mucosal Resection (EMR) Tissue in Patients With Barrett's Dysplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Barrett's Esophagus With High Grade Dsyplasia
Early Esophageal Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Fred Hutchinson Cancer Center
First posted: 2015-02-19
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects undergoing clinically-indicated EMR for BE dysplasia will be invited to participate

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.

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.

Primary outcomes:
measure: distinguishing between normal esophageal squamous mucosa and Barrett's dysplasia
timeFrame: at time of endoscopic mucosal resection
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Cadman Leggett, MD
role: PRINCIPAL_INVESTIGATOR
References: