Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?
Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Inflammation; Barrett's Esophagus
Intervention: dexlansoprazole (Drug); Omeprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s): Ganapathy Prasad, MD, Principal Investigator, Affiliation: Mayo Clinic
Summary
The investigators hypothesize that intensive acid suppression with a long acting high
potency proton pump inhibitor (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.
Clinical Details
Official title: Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?: A Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Inflammation reduction
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Patients who have undergone ablation for BE and HGD or LGD with 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 AST, ALT, Bilirubin or alkaline phosphatase more than five times the
upper limit of normal.
Locations and Contacts
Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States
Additional Information
Starting date: March 2010
Last updated: December 9, 2014
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