Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 09-007252
Sponsor Protocol Number: 09-007252
About this study
The investigators hypothesize that intensive acid suppression with a long acting high potency proton pump inhibitor (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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Patients who have undergone ablation for BE and HGD or LGD with 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 AST, ALT, Bilirubin or alkaline phosphatase more than five times the upper limit of normal.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Prasad Iyer, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available