Phase 4 Completed N=30 Randomized Treatment

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

Source: ClinicalTrials.gov NCT01093755 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcomePrimary: Change in Inflammation Biomarker Tissue PGE2 Level — 1.35; -0.02; 1.19; -0.06 nanograms/gram of tissue — p=0.30

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

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

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.