Mechanisms Preventing Pharyngeal Reflux

NCT05696184 | Recruiting FDA Device

• 1 other identifier: PRO00020544
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal is to define and characterize the manometric characteristics of UES incompetence associated with objectively documented pharyngeal reflux. The investigators will use endoscopic reflux detection as gold standard.

Conditions

GERD

Outcome Measures

Primary Outcomes (2)

• Pressure Data Analysis

  All pressure measurements will be recorded at a 35HZ frequency and measured in reference to the atmospheric pressure UES and LES pressures will be measured utilizing the e-sleeve function of the manometric analysis software. All UES, LES and esophageal baseline pressures will be measured as peaks and troughs over 3 tidal volume respiratory cycles at stable resting conditions when no pharyngeal, gastric, esophageal, UES or LES events are present. Type, frequency, amplitude, onset, and duration of the UES response along with the LES and esophageal body response will be recorded.

  During simulated reflux perfusion of the esophagus

• Videoendoscopic data analysis

  Onset of the entry of colored refluxate into the pharynx though the UES inlet will be determined and correlated with the UES, esophageal and LES pressure phenomena, impedance and pH events. Endoscopic documentation of pharyngeal reflux will be considered the gold standard and impedance and pH data will be compared to it.

  During simulated reflux perfusion of the esophagus

Study Arms (5)

GERD patients with complaint of regurgitation and supra-esophageal reflux disease (SERD)

ACTIVE COMPARATOR

GERD patients with complaint of regurgitation and one of the following supra-esophageal symptoms attributed to reflux of gastric content: chronic cough, frequent throat clearing, history of non-deglutitive aspiration pneumonia, hoarse voice, chronic sinusitis and dental erosion i.e. SE-GERD. Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.

Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy; Diagnostic Test: Slow and rapid intra-esophageal infusion

Age and gender matched healthy controls

ACTIVE COMPARATOR

Controls will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.

Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy; Diagnostic Test: Slow and rapid intra-esophageal infusion

Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint)

ACTIVE COMPARATOR

Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint). Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.

Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy; Diagnostic Test: Slow and rapid intra-esophageal infusion

Asthma patients with and without supra-esophageal symptoms

ACTIVE COMPARATOR

Asthma patients with and without supra-esophageal symptoms (these symptoms include chronic cough, frequent throat clearing, history of non-deglutitive aspiration pneumonia, hoarse voice, chronic sinusitis, and dental erosion). Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.

Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy; Diagnostic Test: Slow and rapid intra-esophageal infusion

Age and gender matched patient controls for diagnosed Barrett's esophagus patients

ACTIVE COMPARATOR

Patient controls for diagnosed Barrett's esophagus patients. Patients will undergo endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing.

Diagnostic Test: Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy; Diagnostic Test: Slow and rapid intra-esophageal infusion

Interventions

Slow and rapid intra-esophageal infusion DIAGNOSTIC_TEST

A 3 mm outer diameter injection tube will be placed through the nose in a fashion that the injection port will be located 5-7cm above the manometrically determined upper border of lower esophageal sphincter (LES). With this arrangement gastroesophageal reflux events will be simulated by intra-esophageal injection of body temperature1/2 normal saline (its ionic nature helps impedance recording and identification of intra-esophageal distribution), 0.1 N HCl. Infused liquid will be colored green using food dye for ease of recognition of pharyngeal reflux. Esophageal clearance will be verified by the presence of an effective peristalsis and return of intra-esophageal impedance and pressure to baseline. Endoscopic views of pharynx will be watched carefully during infusions. At the first sign of reflux, perfusion will be stopped, and participants will be instructed to swallow to avoid any potential airway compromise.

Age and gender matched healthy controls; Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint); Age and gender matched patient controls for diagnosed Barrett's esophagus patients; Asthma patients with and without supra-esophageal symptoms; GERD patients with complaint of regurgitation and supra-esophageal reflux disease (SERD)

Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy DIAGNOSTIC_TEST

Combined manometric/impedance/pH recording: we will use combined solid-state high-resolution manometry and impedance catheter with 36 circumferential pressure sensors, spaced 1 cm apart, 18 impedance sensor couplets spaced 2 cm apart, 3 pH sensors spaced 7 and 10 cm respectively. The catheter will be introduced trans-nasally. Concurrent video-pharyngo-laryngoscopy: to monitor concurrently the pharynx and larynx for entry of simulated refluxate we will use a laryngo-pharyngo-scope passed through the other nostril and positioned within the pharynx such that the UES inlet, vocal cords and pyriform sinuses are visualized. The laryngo-pharyngo-scope images will be synchronized with manometric/impedance/pH recordings by importing and superimposing the endoscopic images onto high resolution manometric recordings. A specially designed timer will be superimposed on the video images for durational analyses of endoscopic images.

Age and gender matched healthy controls; Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint); Age and gender matched patient controls for diagnosed Barrett's esophagus patients; Asthma patients with and without supra-esophageal symptoms; GERD patients with complaint of regurgitation and supra-esophageal reflux disease (SERD)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 85
• GERD patients with complaints of regurgitation and supra-esophageal symptoms will be included and recruited from our GI \& Otolaryngology clinics
• GERD patients without complaint of supra-esophageal symptoms and regurgitation will be included and recruited from our GI \& Otolaryngology clinics
• Asthma patients with and without supra-esophageal symptoms will be included and recruited from clinics affiliated with Medical College of Wisconsin. Asthma patients with the following classifications of asthma severity will be included: intermittent, mild persistent, moderate persistent, and severe persistent (as long as no acute asthma exacerbation at the time of the study)
• Patient definition will be based on position statement and technical reviews of the American Gastroenterological Association and Montreal definition and classification of gastroesophageal and reflux disease (Am J Gastroenterol. 2006;101:1900-1920).
• SERD is defined as patients on long term acid suppressive therapy complaining of persistent regurgitation along with supra-esophageal manifestations such as burning throat, asthma, chronic cough, or hoarseness. Patients will be screened by Reflux Symptom Index \> 13.
• Barrett's esophagus patients will be recruited based on histological diagnosis from previous endoscopic biopsy that will be found using the clinical database warehouse.

You may not qualify if:

• Age \<18 or \>85
• Active alcohol or drug abuse
• History of ear, nose, throat and pulmonary diseases suspected of being GERD induced
• History of head and neck malignancy and chemo-radiation therapy to the head and neck
• Unable to give consent
• History of allergy to Lidocaine for nasal topical anesthesia
• Allergy to green food dye
• Asthma patients with an acute asthma exacerbation with symptoms including breathlessness, wheezing, and chest tightness

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53086, United States

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Reza Shaker, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reza Shaker, MD

CONTACT

4149556840; rshaker@mcw.edu

Mark Kern

CONTACT

4148053826; mkern@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Provost for Clinical and Translational Research, Senior Associate Dean and Director of the Clinical and Translational Science Institute of SE WI, and the Joseph E. Geenen Professor and Chief of Gastroenterology and Hepatology

Model Details: In a heterogeneous group of gastroesophageal reflux disease (GERD) patients, determine and characterize pressure phenomena of the upper esophageal sphincter (UES) incompetence confirmed by concurrent endoscopy.

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: November 1, 2013
• Primary Completion (Estimated): October 12, 2026
• Study Completion (Estimated): October 12, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)