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

Barrett Esophagus Clinical Trial

Official title: The Use of Volumetric Laser Endomicroscopy to Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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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Related Conditions & MeSH terms

• Barrett Esophagus
• Metaplasia
• Recurrence

• NCT number: NCT03670134
• Study type: Interventional
• Source: Mayo Clinic
• Status: Withdrawn
• Phase: N/A
• Start date: August 6, 2018
• Completion date: October 2022