Ablation of Esophageal Inlet Patches in Patients Referred for pH-Testing Due to Possible Extra-Esophageal Symptoms of Gastro-Esophageal Reflux Disease

Background The diagnosis of gastro-esophageal reflux disease (GERD) is difficult when patients present with extra-esophageal symptoms such as chronic cough, frequent throat clearing, globus sensation, sore throat, and hoarseness, as opposed to the traditional symptoms of heartburn and regurgitation.[1-4] These patients are often given a trial of proton pump inhibitors (PPIs) to see if their symptoms improve. They often undergo an upper endoscopy, which is usually unrevealing,[5] and they may be evaluated by other specialties such as otolaryngology and pulmonology. Eventually, some of these patients are referred for esophageal pH-testing to evaluate for objective evidence of acid reflux.

The symptoms of extra-esophageal GERD (EE-GERD) are not specific for GERD and many of them overlap with the symptoms from inlet patches, also known as heterotopic gastric mucosa.[6-7] Inlet patches consist of small areas of gastric mucosa in the upper esophagus that are capable of producing acid.[8-10] Studies in which inlet patches are endoscopically ablated have shown improvement in several extra-esophageal symptoms including globus sensation, sore throat, and cough.[11-15] As inlet patches are notoriously overlooked on upper endoscopy[16] and can cause many of the same symptoms as EE-GERD, we suspect that they may be responsible for the symptoms in some patients who are referred for pH-testing due to suspected EE-GERD. We believe that a careful inspection of the upper esophagus will reveal inlet patches that were missed on initial endoscopy and that ablation of these inlet patches will help improve the patients' symptoms more than the standard treatment for EE-GERD.

Aims The primary aim of this study is to evaluate the improvement in symptoms of patients referred for pH-testing for suspected EE-GERD that are treated with endoscopic ablation of an inlet patch versus those who receive standard PPI therapy. Secondarily, we seek to determine the prevalence of inlet patches in these patients with reportedly normal endoscopies, as well as percentage of patients in this group with a positive pH study.

Methods Patients referred for pH-testing due to symptoms of possible EE-GERD will be evaluated. These patients will have their prior medical history reviewed. Those with a prior normal endoscopy and inadequate response to PPI therapy will be included.

Patients' symptoms will be assessed via a questionnaire across 8 domains including 6 symptoms of possible EE-GERD and 2 subjective scores of how the symptoms are affecting their lives (see Questionnaire below). A visual Likert scale from 0 to 10 will be used. An overall symptom score will be calculated based on the results of the 8 individual domains.