A Comparison of Volumetric Laser Endomicroscopy (VLE) and Endoscopic Mucosal Resection (EMR) in Patients With Barrett's Dysplasia or Intramucosal Adenocarcinoma

Intramucosal Adenocarcinoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862666
• Other study ID #: 12_01
• Status: Completed
• Phase: N/A
• First received: May 16, 2013
• Last updated: June 17, 2015
• Start date: May 2013
• Est. completion date: January 2015

Study information

• Verified date: March 2014
• Source: NinePoint Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Dutch Health Care InspectorateNetherlands: Independent Ethics Committee
• Study type: Observational

Clinical Trial Summary

Barrett's esophagus (BE) is a pre-neoplastic condition formed by the metaplasia of the normal squamous mucosa of the distal esophagus into a specialized intestinal mucosa. Its development is mostly associated with chronic injury from gastroesophageal reflux. BE is widely considered the leading risk factor for the development of esophageal adenocarcinoma (EAC).

Volumetric laser endomicroscopy (VLE) can be thought of as an analogous technique to ultrasound, however, instead of producing an image from the scattering of sound waves, it utilizes optical scattering based on differences in tissue composition to form a two-dimensional image. The benefit of VLE over ultrasound is that it is capable of generating cross-sectional images of tissues with an axial-resolution of up to 10 micrometers, which is comparable to low-power microscopy.

The proposed trial will evaluate the ability of physicians to use VLE to visualize high grade intraepithelial neoplasia (HGIN) or intramucosal adenocarcinoma (IMC) in both the ex-vivo and in-vivo setting and correlate those images to standard histology of endoscopic mucosal resection specimens as the gold standard.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett'S-associated Dysplasia
• Intramucosal Adenocarcinoma

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	AZ

Sponsors (1)

Lead Sponsor	Collaborator
NinePoint Medical

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The correlation of features seen on VLE images to those seen on histopathology from mucosal resection specimens.	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.	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.	No
Secondary	The creation of an image atlas, to determine the intra- and inter-observer agreement on VLE images in correlation with histopathology, resulting in refinement of the existing VLE image interpretation criteria and the validation of the VLE classification.	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.	VLE images will be obtained during the day of the EGD (baseline). There is no follow-up period for this protocol. The creation of the image atlas will occur at the completion of enrollment.	No