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

Inflammation Clinical Trial

Official title:

Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093755
• Other study ID #: 09-007252
• Status: Completed
• Phase: Phase 4
• First received: March 24, 2010
• Last updated: February 19, 2016
• Start date: March 2010
• Est. completion date: November 2014

Study information

• Verified date: February 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Inflammation

Intervention

Drug:
• dexlansoprazole
Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months
• Omeprazole
Escalating doses of omeprazole (20-60 mg/day) for 6 months

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Inflammation Biomarker Tissue PGE2 Level	Change from baseline in esophageal tissue biopsy prostaglandin E2 (PGE2) level, as determined by enzyme immunoassay	3 months, 6 months	No
Primary	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.	3 months, 6 months	No