Back to resultsDoes Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?
Primary Purpose
Inflammation, Barrett's Esophagus
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
dexlansoprazole
Omeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation focused on measuring Barrett's Esophagus, Radiofrequency ablation, Patients post-radiofrequency ablation for Barrett's Esophagus.
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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
dexlansoprazole
omeprazole
Arm Description
Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months
Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.
Outcomes
Primary Outcome Measures
Change in Inflammation Biomarker Tissue PGE2 Level
Change from baseline in esophageal tissue biopsy prostaglandin E2 (PGE2) level, as determined by enzyme immunoassay
Change in Esophageal Inflammation Biomarker COX-2 Gene Expression
Change from baseline in esophageal issue biopsy cyclooxygenase-2 (COX-2) gene expression, as determined by Western blot.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01093755
Brief Title
Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?
Official Title
Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
Patients who achieve complete remission of intestinal metaplasia following ablation will be randomized (using concealed allocation, like the flip of a coin) to either intensive acid suppression with dexlansoprazole 60-90 mg/day or to symptom guided acid suppression with escalating doses of omeprazole (20-60 mg/day) for 6 months. Control of reflux will be assessed using 24 hour ambulatory pH monitoring. The need to escalate drug dosage at the 3 month visit will be determined by presence of excessive acid exposure on ambulatory pH monitoring. Biopsies of esophageal tissue will be obtained at baseline, then at 3 months and 6 months following randomization to measure changes in inflammatory biomarkers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Barrett's Esophagus
Keywords
Barrett's Esophagus, Radiofrequency ablation, Patients post-radiofrequency ablation for Barrett's Esophagus.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexlansoprazole
Arm Type
Active Comparator
Arm Description
Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months
Arm Title
omeprazole
Arm Type
Active Comparator
Arm Description
Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.
Intervention Type
Drug
Intervention Name(s)
dexlansoprazole
Other Intervention Name(s)
Dexilant
Intervention Description
Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Other Intervention Name(s)
Prilosec
Intervention Description
Escalating doses of omeprazole (20-60 mg/day) for 6 months
Primary Outcome Measure Information:
Title
Change in Inflammation Biomarker Tissue PGE2 Level
Description
Change from baseline in esophageal tissue biopsy prostaglandin E2 (PGE2) level, as determined by enzyme immunoassay
Time Frame
3 months, 6 months
Title
Change in Esophageal Inflammation Biomarker COX-2 Gene Expression
Description
Change from baseline in esophageal issue biopsy cyclooxygenase-2 (COX-2) gene expression, as determined by Western blot.
Time Frame
3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prasad Iyer, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?
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