Overview

Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?

Status:
Completed

Trial end date:
2014-11-01

Target enrollment:
0

Participant gender:
All

Summary

The investigators hypothesize that intensive acid suppression with a long acting high potency proton pump inhibitor (PPI) drug dexlansoprazole will lead to a greater decrease in levels of inflammatory mediators (compared to conventional PPIs) in the esophagus, which could potentially lead to decreased recurrence of intestinal metaplasia following endoscopic ablation.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Mayo Clinic

Treatments:

Dexlansoprazole
Lansoprazole
Omeprazole

Criteria

Patients who have undergone ablation for Barrett's Esophagus (BE) and High Grade Dysplasia
(HGD) or Low Grade Dysplasia (LGD) with Photodynamic Therapy (PDT)/Radiofrequency ablation
and endoscopic mucosal resection who have no endoscopic and histologic evidence of
specialized intestinal metaplasia on biopsies from the esophagus on two successive
endoscopies post ablation will be offered enrollment in the study.

Inclusion criteria:

1. Absence of intestinal metaplasia on endoscopy (under Narrow Band Imaging) and on
histology (from biopsies taken from gastroesophageal junction and distal esophagus) on
two successive surveillance endoscopies.

2. Able to consent to study

3. Males and females age 18-90

4. Life expectancy of 5 years or greater.

Exclusion criteria:

1. Pregnancy

2. Inability to consent for the procedure

3. Anticoagulation therapy precluding performance of ambulatory pH monitoring and/or
biopsies

4. Intolerance to proton pump inhibitors

5. Elevation in Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), (liver
enzymes), bilirubin or alkaline phosphatase more than five times the upper limit of
normal.