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Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia

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ClinicalTrials.gov Identifier: NCT03670134
Recruitment Status : Not yet recruiting
First Posted : September 13, 2018
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
American Society for Gastrointestinal Endoscopy
Information provided by (Responsible Party):
Cadman Leggett, Mayo Clinic

Brief Summary:
Researchers are trying to see if the Nvision® Imaging System (VLE) can accurately determine the risk of recurrent Barrett's esophagus in patients with Barrett's esophagus which have been clear of disease.

Condition or disease Intervention/treatment Phase
Barrett Esophagus Device: The Nvision VLE Imaging System Not Applicable

Detailed Description:

Patients with Barrett's Esophagus (BE) undergoing endoscopic therapy through our Barrett's Esophagus Unit will be approached for study enrollment. Patients with no endoscopic evidence of BE will be considered for the study. Surveillance biopsies will be obtained per standard clinical protocol and reviewed to confirm absence of intestinal metaplasia. Patients who have achieved complete eradication of intestinal metaplasia (CRIM) will be enrolled in the study and will undergo the Nvision® Imaging System (VLE). Patients enrolled in the study will undergo clinical follow-up consisting of surveillance endoscopy every 3 months for 1 year. Surveillance endoscopy intervals may be prolonged to every 6 months in the second year, and annually thereafter. At each follow-up visit, endoscopic data will be collected to determine if patients remain in CRIM or show evidence of recurrent disease. Patients will be followed for 1 year (endpoint 1) and 3 years (endpoint 2).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Use of Volumetric Laser Endomicroscopy to Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2022

Arm Intervention/treatment
Experimental: Volumetric laser Endomicroscopy (VLE)
Volumetric laser Endomicroscopy (VLE) is a second-generation optical coherence tomography platform that can image the human esophagus in cross-section at microscopic resolution this will performed by using the Nvision VLE Imaging System.
Device: The Nvision VLE Imaging System
Volumetric laser Endomicroscopy (VLE) will be performed by using the Nvision VLE Imaging System (Nine Point Medical, MA) consists of an imaging console, monitor and optical probe. The optical probe is centered by a balloon (diameter: 14 mm, 17 mm, 20 mm; length: 6 cm) that is deployed through a diagnostic gastroscope's instrument channel. Imaging is performed by automatic helical pullback of the probe from the distal to the proximal end of the balloon over 90 seconds.




Primary Outcome Measures :
  1. Determine association between number of glandular structures measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy [ Time Frame: 1 year ]
    Measure the number of glandular structures observed with volumetric laser endomicroscopy in patients who remain free of Barrett's esophagus and in those with recurrent disease. Report the mean and standard-deviation of this metric and determine a statistical significant difference using the Student's t-test.

  2. Determine association between distribution of glandular structures measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy [ Time Frame: 1 year ]
    Measure the distribution (gastric cardia versus esophagus) of glandular structures observed with volumetric laser endomicroscopy in patients who remain free of Barrett's esophagus and in those with recurrent disease. Report the mean and standard-deviation of this metric and determine a statistical significant difference using the Student's t-test.

  3. Determine association between thickness of neosquamous epithelium measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy [ Time Frame: 1 year ]
    Measure the thickness of neosquamous epithelium (mm) with volumetric laser endomicroscopy in patients who remain free of Barrett's esophagus and in those with recurrent disease. Report the mean and standard-deviation of this metric and determine a statistical significant difference using the Student's t-test.


Secondary Outcome Measures :
  1. Develop a volumetric laser endomicrosopy feature scoring index to stratify the risk of disease recurrence in patients with Barrett's esophagus following treatment [ Time Frame: 3 years ]
    The proposed model will stratify patients into two categories (1) low risk of recurrence and (2) high risk of recurrence. Low risk of disease recurrence is defined by a rate of <5% per patient-year. High risk of disease recurrence is defined by a rate of >10% per patient year.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient undergoing an upper endoscopy with prior biopsy confirmed Barrett's Esophagus.
  • Ability to provide written, informed consent
  • No significant esophagitis (LA grade <B, C, and D)

Exclusion Criteria:

  • Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use.
  • Prior esophageal or gastric surgical resection
  • Significant esophageal stricture requiring dilatation
  • Patients who require anti-coagulation for who biopsy would be contraindicated
  • Patients who are known to be pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03670134


Contacts
Contact: Magdalen (Medy) A Clemens 507-285-7495 Clemens.Magdalen@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Magdalen (Medy) A Clemens, MD    507-285-7495    Clemens.Magdalen@mayo.edu   
Principal Investigator: Cadman L Leggett, MD         
Sponsors and Collaborators
Mayo Clinic
American Society for Gastrointestinal Endoscopy
Investigators
Principal Investigator: Cadman L Leggett, MD Mayo Clinic

Responsible Party: Cadman Leggett, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03670134     History of Changes
Other Study ID Numbers: 18-003333
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Cadman Leggett, Mayo Clinic:
Laser Endomicroscopy
Intestinal Metaplasia

Additional relevant MeSH terms:
Recurrence
Barrett Esophagus
Metaplasia
Disease Attributes
Pathologic Processes
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases