The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors
Condition: Gastroesophageal Reflux Disease; Eosinophilic Esophagitis
MeSH terms: Gastroesophageal Reflux; Esophagitis; Eosinophilic Esophagitis; Heartburn
Intervention: Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptoms
Intervention description: Treat with lansoprazole 30 mg BID for 2 weeks, perform endoscopic examination with esophageal biopsy
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastroesophageal reflux; Proton pump inhibitor; Eosinophilic esophagitis

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.
    

Eligibility criteria:

        Inclusion Criteria:Male and female patients ages 18 years and older who are referred to the
        Division of Gastroenterology at the Dallas VA Medical Center for the evaluation of
        heartburn that is refractory to PPI therapy

        Exclusion Criteria:

          1. Patients unwilling or unable to provide informed consent.

          2. Allergy to lansoprazole.

          3. Patients taking warfarin.

          4. Coagulopathy that precludes safe biopsy of the esophagus.

          5. Comorbidity that precludes safe participation in the study.

          6. Pregnancy.