Efficacy of Dx-pH Probe in Diagnosing Extra-esophageal Reflux Disease (ADHERE)

Vanderbilt University Medical Center

Status: Completed

Conditions: Larynx Disease; GERD

Treatments: Procedure: Manometry; Device: Dx-pH Probe

Study type: Interventional

Funder types: Other

Identifiers

NCT00388453

060860

Details and patient eligibility

About

The purpose of this study is to establish the clinical application of a new device that records pH changes in the hypopharynx. The investigators also aim to compare the consistency of distal esophageal pH with hypopharyngeal pH using both the "short" and the "long" catheters in patients.

Full description

Gastroesophageal reflux disease (GERD) has been linked to many disorders and can be diagnosed through a variety of modalities utilizing 24 hour ambulatory pH monitoring which can register the duration, pattern and symptom correlation of distal esophageal acid exposure. This can be accomplished via a catheter probe connected from outside the body and placed through a nostril, advanced past the hypopharynx and down into the distal esophagus. Or, a small pH detector temporarily implanted in the distal esophagus during endoscopy can record reflux events. However, despite available technologies, there has long been a deficiency in detecting extra-esophageal reflux in the upper esophagus/ hypopharynx. This is of interest for gastroenterologists, otolaryngologists, and pulmonologists in the evaluation of extra-esophageal reflux as a potential culprit for asthma, chronic cough, laryngitis, globus, and non-cardiac chest pain. Until now, there has not been a device sensitive enough for accurately detecting extra-esophageal reflux (EERD) and clinicians have relied upon subjective response to empiric treatment with acid reducing medications to determine whether acid reflux was at the root of the symptoms. There are currently no well designed published studies with this device to assess its role in this group of difficult to treat patients.

Enrollment: 47 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male and female volunteers aged 18 to 65 years old.
2. Control group: No known history of GERD or EERD or prior PPI use.
3. GERD group: Patients with known history of GERD based on prior response to either histamine inhibitors (H2 blockers) or proton pump inhibitors (PPIs) and/or endoscopic esophagitis identified at endoscopy.
4. EERD group: Patients with chronic cough, asthma and laryngeal findings felt to be GERD related.

Exclusion criteria

1. Use of H2 blockers or PPIs within one week prior to and during the study for the GERD and EERD patients. No prior PPI use is allowed for the control population.
2. Use of antacids (Rolaids, Tums, Pepto-Bismol, etc.) within one day prior to or during the study.
3. Esophageal motility abnormalities (achalasia, esophageal spasm, severe dysphagia)
4. Expected non-compliance.
5. Positive history of ongoing alcohol or tobacco use and inability to refrain from using either during study duration (24 hours).
6. Recent nasal surgery or nasal obstruction.
7. Significant medical conditions that, in the investigator's judgment, would compromise the subject's health and safety (mental disability, psychiatric impairment, inability to read or comprehend the consent form)
8. Pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 3 patient groups

1

Active Comparator group

Description:

Healthy volunteers with no history of GERD or EERD or Proton Pump Inhibitor (PPI) use

Treatment:

Device: Dx-pH Probe

Procedure: Manometry

2

Experimental group

Description:

subject is known to have GERD based on symptoms and previous positive response to PPI

Treatment:

Device: Dx-pH Probe

Procedure: Manometry

3

Experimental group

Description:

subject is known to have EERD based on symptoms and previous positive response to PPI

Treatment:

Device: Dx-pH Probe

Procedure: Manometry