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

NCT ID: NCT00388453

Last Updated: 2017-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2013-07-31

Brief Summary

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.

Detailed 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.

Conditions

GERD; Larynx Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: ACTIVE_COMPARATOR

Dx-pH Probe

Intervention Type: DEVICE

24 hour ph monitoring

Manometry

Intervention Type: PROCEDURE

procedure to measure pH at the Lower esophageal sphincter (LES) and Upper esophageal sphincter (UES)

2

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

Group Type: EXPERIMENTAL

Dx-pH Probe

Intervention Type: DEVICE

24 hour ph monitoring

Manometry

Intervention Type: PROCEDURE

procedure to measure pH at the Lower esophageal sphincter (LES) and Upper esophageal sphincter (UES)

3

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

Group Type: EXPERIMENTAL

Dx-pH Probe

Intervention Type: DEVICE

24 hour ph monitoring

Manometry

Intervention Type: PROCEDURE

procedure to measure pH at the Lower esophageal sphincter (LES) and Upper esophageal sphincter (UES)

Interventions

Dx-pH Probe

24 hour ph monitoring

Intervention Type: DEVICE

Manometry

procedure to measure pH at the Lower esophageal sphincter (LES) and Upper esophageal sphincter (UES)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Vaezi

Principal Investigatori

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael F Vaezi, MD, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

060860

Identifier Type: -

Identifier Source: org_study_id