Clinical trial NCT02997527: [Impedance Measurement for Non-Erosive Reflux Disease
Official title: Measurement of the Distal 5 cm of the Esophagus in Patients With Non-Erosive Reflux Disease and Controls
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: GERD
Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done to determine if people with and without GERD or trouble swallowing have increased esophageal mucosa impedance (food getting into the esophageal tissue).

Detailed description: In patients with gastroesophageal reflux disease (GERD) but without gross evidence of esophageal injury, confirmation of acid reflux is typically performed through testing that measures reflux at or proximal to 5 cm above the gastroesophageal junction. These tests such as pH/impedance monitoring and Bravo probe placement in the esophagus have been the gold standard for diagnosing and quantitating the degree of gastroesophageal reflux. This stands in contrast to the concept that the esophagus distal to 5 cm is first and foremost exposed to gastroesophageal reflux and that most injury in the form of erosive esophagitis is seen in the 4cm segment below where this instruments measure reflux. As a result, this type of testing may not allow for full understanding of the pathophysiology of GERD. Furthermore, with refluxed acid exposure limited to the distal esophagus in some patients, use of conventional pH testing could lead to inaccurate diagnosing of GERD.

Esophageal impedance testing measures epithelial integrity as reflected through the ability of the mucosa to conduct electric current. As dilation of intercellular spaces in biopsies from patients with GERD is considered the earliest indication of esophageal injury in response to reflux in the absence of gross endoscopic injury, the measure of increased current conduction through these dilated spaces has been shown to be an accurate means of diagnosing patients with non-erosive reflux disease. To this point, most esophageal impedance has been measured using impedance ports placed at locations similar to the pH probes in a combined intra-esophageal ambulatory catheter. As a result, the most distal point of impedance measurement is also 5 cm above the gastroesophageal junction. Recently, a site specific endoscopically placed impedance probe has been developed that can measure esophageal mucosal impedance at any point of the esophagus.

In this study the Principal Investigator would like to look at patients with and without reflux symptoms measuring impedance at 1,2,3,4 and 5 cm at the 6 o'clock position above the Gastroesophageal Junction.

Eligibility criteria: Inclusion Criteria:

* Adults ages 18-90
* Patients with heartburn and no hiatal hernia undergoing clinically indicated endoscopy
* Patients with heartburn and a hiatal hernia \> 3cm undergoing clinically indicated endoscopy
* Patients undergoing clinically indicated upper endoscopy for indications other than dysphagia or GERD
* Patients with reflux symptoms, a normal appearing esophagus on clinically indicated endoscopy undergoing clinically indicated ambulatory pH/impedance testing.

Exclusion Criteria:

* Previous gastric or esophageal surgery.
* Use of proton pump inhibitors 1 month prior to the study
* Patients on anticoagulation other than aspirin or clopidogrel
* Presence of erosive esophagitis or Barrett's esophagus

Primary outcomes:
measure: Epithelial integrity in GERD an Non-GERD subjects
timeFrame: 1 year
Secondary outcomes:
measure: Epithelial integrity by Mucosal Impedance verses gold standard Ambulatory pH monitoring
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: David A Katzka
role: PRINCIPAL_INVESTIGATOR
References: