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18 Years
Open (Enrolling)
Barrett'S-associated Dysplasia, Intramucosal Adenocarcinoma

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Trial Information

The diagnosis of dysplasia and early adenocarcinoma in BE remains challenging. At present,
endoscopy with biopsy of suspected BE lesions is the only available method. However, the
endoscopic recognition of early dysplasia in BE relies on the subjective visual recognition
by an endoscopist. The subtle mucosal variations and early dysplastic changes in the
esophagus may easily be missed. The development of a wide-field, high resolution endoscopic
microscopy could enhance the early detection and treatment of dysplasia in BE.

Inclusion Criteria:

- Males and females over the age of 18 years.

- Patients with either suspected or confirmed Barrett's-associated dysplasia or
intramucosal adenocarcinoma presenting for endoscopy likely requiring EMR.

- Only en-bloc resections will be investigated, requiring lesions with a maximum
diameter of 15 mm with a Paris classification of 0-IIa, b, c, or a combination.

- Ability to provide written, informed consent.

- Women of childbearing potential must be willing to take a pregnancy test.

Exclusion Criteria:

- Patients on anticoagulation.

- Patients with esophageal varices that preclude either mucosal resection or biopsies.

- Presence of an esophageal mass that precludes full distention of the balloon from the
NvisionVLE Catheter.

- Patients with esophageal strictures that would prevent adequate expansion of the
balloon from the NvisionVLE Catheter.

- Patients with known inflammatory disease, esophageal tears or ulcers, which would
prohibit full distention of the balloon from the NvisionVLE Catheter.

- Patients with known eosinophilic esophagitis.

- Patients that are pregnant.

- Patients with a history of hemostasis disorders*.

- Patients with esophagitis above grade A.

- 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 Willibrand's disease or other known
platelet malfunction disorders.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The correlation of features seen on VLE images to those seen on histopathology from mucosal resection specimens.

Outcome Description:

All VLE images will be evaluated by two independent reviewers (not the trial endoscopist performing the scan), who are blinded to the histological finding of the corresponding EMR specimen. A predefined classification scheme will be used for VLE assessment.

Outcome Time Frame:

VLE images will be obtained during the day of the EGD (baseline). There is no follow-up period for this protocol. Correlation of features from VLE to histo will occur at the completion of enrollment.

Safety Issue:


Principal Investigator

Jacques Bergman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)


Netherlands: Dutch Health Care Inspectorate

Study ID:




Start Date:

May 2013

Completion Date:

Related Keywords:

  • Barrett'S-associated Dysplasia
  • Intramucosal Adenocarcinoma
  • Barrett's Esophagus
  • Dysplasia
  • Intramucosal Adenocarcinoma
  • EMR
  • Endoscopy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous