Phase 4
N=30
Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?
Inflammation · Barrett's Esophagus
Bottom Line
View on ClinicalTrials.gov: NCT01093755 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Change in Inflammation Biomarker Tissue PGE2 Level — 1.35; -0.02; 1.19; -0.06 nanograms/gram of tissue — p=0.30
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- dexlansoprazole (Drug); Omeprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Inflammation Biomarker Tissue PGE2 Level |
1.35; -0.02; 1.19; -0.06 | 0.30 |
| PRIMARY Change in Esophageal Inflammation Biomarker COX-2 Gene Expression |
36.81; 27.17; 56.54; 25.49 | 0.70 |
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.
Eligibility 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
- 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.
- Able to consent to study
- Males and females age 18-90
- Life expectancy of 5 years or greater.
Exclusion criteria
- Pregnancy
- Inability to consent for the procedure
- Anticoagulation therapy precluding performance of ambulatory pH monitoring and/or biopsies
- Intolerance to proton pump inhibitors
- Elevation in Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), (liver enzymes), bilirubin or alkaline phosphatase more than five times the upper limit of normal.
Data sourced from ClinicalTrials.gov (NCT01093755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.