The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors
Status:
Terminated
Trial end date:
2010-05-01
Target enrollment:
Participant gender:
Summary
Background: Up to 40% of patients who are treated with PPIs for symptoms that are thought to
be due to GERD experience only incomplete relief of their symptoms. Those patients are deemed
"PPI failures." Esophageal pH monitoring studies have shown that PPI failure rarely is due to
persistent acid reflux. Recently, heartburn that is refractory to treatment with PPIs has
been described in patients with eosinophilic esophagitis, a disorder of unknown etiology in
which eosinophils infiltrate the squamous epithelium of the esophagus, where they cause
symptoms and tissue injury. Presently, it is not clear how often eosinophilic esophagitis
underlies PPI failure for patients with GERD symptoms.
Purpose: To estimate the frequency with which eosinophilic esophagitis is the cause of "PPI
failure" in patients thought to have heartburn due to GERD.
Methods: Patients referred to the Division of Gastroenterology at the Dallas VA Medical
Center for the evaluation of heartburn that is refractory to PPI therapy will be invited to
participate in the study. Patients who provide informed consent will have a medical history
taken. Women of child bearing potential will have a pregnancy test. The patients' current PPI
therapy will be discontinued, and patients will be treated with lansoprazole 30 mg BID for
one week. The patient will return to the clinic one week later. Patients who feel that their
heartburn has not improved by more than 50% from baseline will have an endoscopic evaluation.
During the endoscopic examination, biopsy specimens will be taken as follows: A. Two
specimens from the proximal esophagus at 20 cm from the incisor teeth. B. Two specimens from
the mid-esophagus at 28 cm from the incisor teeth. C. Two specimens from the distal
esophagus, 3 cm above the squamo-columnar junction. D. Two specimens from the distal
esophagus, 1 cm above the squamo-columnar junction. E. Two specimens from the second portion
of the duodenum (to see if the eosinophilia is confined to the esophagus, or part of a more
extensive eosinophilic gastroenteritis). A diagnosis of eosinophilic esophagitis will be made
if there is at least one high-power field with >25 eosinophils, or two or more high-power
fields with >15 eosinophils.
Potential Benefits: This study will provide an estimate on the frequency with which
eosinophilic esophagitis is the cause of "PPI failure" in patients thought to have heartburn
due to GERD. This has substantial potential importance for patient management.