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

Not Applicable

Withdrawn

• Conditions: Barrett Esophagus
• Interventions: Device: The Nvision VLE Imaging System

• Registration Number: NCT03670134
• Lead Sponsor: 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.

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).

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Study Timeline

• Study Start: 2018-08-06
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-13
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-17
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Volumetric laser Endomicroscopy (VLE)	The Nvision VLE Imaging System	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.

Primary Outcome Measures

Name	Time	Method
Determine association between distribution of glandular structures measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy	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.
Determine association between thickness of neosquamous epithelium measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy	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.
Determine association between number of glandular structures measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy	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.

Secondary Outcome Measures

Name	Time	Method
Develop a volumetric laser endomicrosopy feature scoring index to stratify the risk of disease recurrence in patients with Barrett's esophagus following treatment	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.