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

• ClinicalTrials.gov Identifier: NCT01093755
• Recruitment Status: Completed
• First Posted: March 26, 2010
• Results First Posted: March 17, 2016
• Last Update Posted: March 17, 2016
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Prasad G. Iyer, Mayo Clinic

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.

Condition or disease	Intervention/treatment	Phase
Inflammation; Barrett's Esophagus	Drug: dexlansoprazole; Drug: Omeprazole	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?: A Randomized Controlled Trial
• Study Start Date: March 2010
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: dexlansoprazole; Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months	Drug: dexlansoprazole; Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months; Other Name: Dexilant
Active Comparator: omeprazole; Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.	Drug: Omeprazole; Escalating doses of omeprazole (20-60 mg/day) for 6 months; Other Name: Prilosec

Outcome Measures

Primary Outcome Measures :

1. Change in Inflammation Biomarker Tissue PGE2 Level [ Time Frame: 3 months, 6 months ]
   Change from baseline in esophageal tissue biopsy prostaglandin E2 (PGE2) level, as determined by enzyme immunoassay
2. Change in Esophageal Inflammation Biomarker COX-2 Gene Expression [ Time Frame: 3 months, 6 months ]
   Change from baseline in esophageal issue biopsy cyclooxygenase-2 (COX-2) gene expression, as determined by Western blot.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Prasad Iyer, MD; Mayo Clinic

More Information

• Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01093755
• Other Study ID Numbers: 09-007252
• First Posted: March 26, 2010
• Results First Posted: March 17, 2016
• Last Update Posted: March 17, 2016
• Last Verified: February 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Prasad G. Iyer, Mayo Clinic:

Barrett's Esophagus; Radiofrequency ablation; Patients post-radiofrequency ablation for Barrett's Esophagus.

Additional relevant MeSH terms:

Barrett Esophagus; Esophagitis; Inflammation; Pathologic Processes; Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Omeprazole; Dexlansoprazole; Lansoprazole; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action