Original ResearchFull Report: Clinical—Alimentary TractMucosal Impedance Discriminates GERD From Non-GERD Conditions
Section snippets
Patients and Methods
This study was performed in accordance with the Declaration of Helsinki, Good Clinical Practice, and applicable regulatory requirements. Each patient signed a consent form before undergoing any study-related procedures. The Vanderbilt Institutional Review Board approved this clinical trial (IRB# 101109; NCT01556919). All authors had access to the study data and reviewed and approved the final manuscript.
Demographics
A total of 268 patients were studied and stratified into those with E+ (n = 61) (LA grade A, 28; grade B, 18; grade C, 10; and grade D, 5), E−/pH+ (n = 81), E−/pH− (n = 93), achalasia (n = 18), and EoE (n = 15) (Table 1). As expected, patients with EoE were younger than those in other groups; in addition, like patients with achalasia, patients with EoE were mostly male (P < .001) and had significantly more dysphagia as the presenting symptom than those in other groups (P < .001). There were no
Discussion
In this prospective study, we showed the clinical performance of an innovative MI measurement device in patients with GERD. Important observations from our study include the following: (1) the MI pattern is unique in GERD compared with non-GERD patients; (2) low MI is an important determinant of changes along the esophageal epithelium, which is similar for GERD and those with EoE, but the MI pattern along the esophagus is distinctive in the 2 conditions; (3) GERD-related low MI recovers after
Acknowledgments
Partial support for Dr. Ates’s salary was made possible by a kind financial contribution from The Bill and Carol Latimer Charitable Trust.
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Conflicts of interest The authors disclose the following: J.M. is affiliated with Sandhill Scientific Inc (Denver, CO), which helped design the special mucosal impedance catheter used in this study. His involvement in the study was provision of technical support for the catheter design. He had no influence on the study design, conduct, analysis, or final manuscript. Vanderbilt University and Sandhill Scientific Inc jointly hold a patent on the mucosal impedance concept and device. Otherwise, there are no financial relationships between any of the other authors and Sandhill Scientific Inc. This was disclosed to the patients who participated in this study. The remaining authors disclose no conflicts.