Esophageal Muscle Function Study for Acid Reflux

Overseen By Mark Kern

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Active alcohol or drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the esophageal muscle function study for acid reflux safe for humans?

The techniques used in the study, such as high-resolution manometry (HRM) and impedance monitoring, have been used safely in humans for diagnosing esophageal and swallowing disorders. These methods are considered standard and have been used in both adults and children without significant safety concerns. ^{1 2 3 4 5}

How does this treatment for acid reflux differ from other treatments?

This study focuses on using advanced diagnostic techniques like high-resolution impedance manometry (HRIM) and multichannel intraluminal impedance-pH (MII-pH) to better understand esophageal muscle function in acid reflux, which is different from traditional treatments that primarily focus on reducing stomach acid. These techniques provide a more detailed analysis of both acid and non-acid reflux, potentially leading to more personalized treatment approaches. ^{4 5 6 7 8}

What data supports the effectiveness of this treatment for acid reflux?

The study on 'Validation of Pharyngeal Acid Reflux Episodes Using Hypopharyngeal Multichannel Intraluminal Impedance-pH' suggests that the HMII-pH technique can effectively detect pharyngeal reflux, which is relevant for understanding acid reflux. Additionally, 'Combined impedance-manometry for the evaluation of esophageal disorders' indicates that high-resolution impedance-manometry (HRIM) has been used to assess esophageal motor function, which is related to acid reflux management. ^{1 2 4 5 8}

Who Is on the Research Team?

Reza Shaker, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with asthma of varying severity, GERD with or without supra-esophageal symptoms like chronic cough or hoarseness, and Barrett's esophagus confirmed by biopsy. Excluded are those under 18 or over 85, active substance abusers, certain ENT disease histories, pregnant women, Lidocaine allergy sufferers, green food dye allergies, and acute asthma exacerbation patients.

Inclusion Criteria

I have asthma without a current severe flare-up.

I have GERD with symptoms like heartburn and throat issues.

I have been diagnosed with gastroesophageal reflux disease.

Exclusion Criteria

Pregnant women

History of allergy to Lidocaine for nasal topical anesthesia

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Simulated Reflux Testing

Participants undergo simulated reflux perfusion of the esophagus to analyze UES, LES, and esophageal pressure responses

During testing sessions

Multiple visits for testing

Endoscopic Evaluation

Endoscopic evaluation of reflux and upper esophageal sphincter (UES) manometric testing

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Concurrent manometry/impedance/pH with video pharyngo-laryngoscopy
• Slow and rapid intra-esophageal infusion

Trial Overview The study tests how well the upper esophageal sphincter works to prevent acid reflux into the throat. It involves slow and rapid infusions in the esophagus while monitoring pressure changes and pH levels alongside video imaging of the throat area.

How Is the Trial Designed?

Group I: GERD patients with complaint of regurgitation and supra-esophageal reflux disease (SERD) Active Control 2 Interventions

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.

Group II: Asthma patients with and without supra-esophageal symptoms Active Control 2 Interventions

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.

Group III: Age and gender matched patient controls (GERD without regurgitation and supra-esophageal complaint) Active Control 2 Interventions

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.

Group IV: Age and gender matched patient controls for diagnosed Barrett's esophagus patients Active Control 2 Interventions

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

Group V: Age and gender matched healthy controls Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

A systematic review of 62 studies on high resolution pharyngeal manometry (HRM) and high resolution impedance manometry (HRIM) revealed significant variability in methodology, which can hinder the ability to replicate studies and compare results effectively.

Most studies used the ManoScan™ system and reported the use of topical anesthesia, but only a small percentage provided data on measurement reliability, highlighting a need for improved methodological reporting in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of current methodology of high resolution pharyngeal manometry with and without impedance. Winiker, K., Gillman, A., Guiu Hernandez, E., et al.[2020]

In a study involving 90 patients with suspected laryngopharyngeal reflux and 28 healthy volunteers, the HMII-pH technology successfully identified 80% of candidate pharyngeal acid reflux episodes as confirmed cases, indicating its efficacy in detecting pharyngeal reflux.

The interobserver reproducibility for diagnosing these episodes was high at 92.2%, suggesting that the HMII-pH method provides reliable results across different observers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of Pharyngeal Acid Reflux Episodes Using Hypopharyngeal Multichannel Intraluminal Impedance-pH. Chen, YY., Wang, CC., Lin, YC., et al.[2023]

Pharyngeal high-resolution impedance manometry (HRIM) is now a practical tool for assessing swallowing dysfunction, providing both qualitative and quantitative measures of swallow function, including the swallow risk index (SRI) and post-swallow impedance ratio (PSIR).

The use of HRIM can help identify specific issues in swallowing mechanics, such as pressure and timing in the hypopharynx and upper esophageal sphincter, which may guide treatment strategies and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis of Swallowing Disorders: How We Interpret Pharyngeal Manometry. Cock, C., Omari, T.[2023]

The introduction of automated impedance-manometry (AIM) allows for combined analysis of impedance and manometry data, revealing subtle abnormalities in esophageal function in patients with nonobstructive dysphagia who previously showed normal results with conventional methods.

AIM analysis has the potential to predict postfundoplication dysphagia by identifying preoperative characteristics, enhancing the management of esophageal motor disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined impedance-manometry for the evaluation of esophageal disorders. Holloway, RH.[2022]

In a study of 38 asymptomatic volunteers using 24-hour MII-pH monitoring, it was found that laryngopharyngeal reflux events predominantly occurred in a gaseous state (95%) and were mostly detected while the subjects were upright (89%).

The study revealed that acid reflux is rare in healthy individuals, with only 1% of laryngopharyngeal reflux events being acidic, suggesting that traditional diagnostic criteria for gastroesophageal reflux disease may not be applicable for laryngopharyngeal reflux disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study on laryngopharyngeal and esophageal reflux characteristics using 24-h multichannel intraluminal impedance-pH monitoring in healthy volunteers. Hou, C., Chen, M., Chen, T., et al.[2021]

Esophageal impedance monitoring is now considered the gold standard for diagnosing gastroesophageal reflux disease (GERD) in both adults and children, significantly improving diagnostic accuracy for reflux symptoms.

High-resolution manometry (HRM) is more effective than other methods for diagnosing achalasia and helps classify esophageal disorders in patients with non-obstructive dysphagia, indicating its potential in managing dysphagia after gastric band surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of esophageal impedance monitoring and high-resolution manometry. Kessing, BF., Smout, AJ., Bredenoord, AJ.[2022]

In a study of 100 patients undergoing laparoscopic fundoplication for GERD, those with reflux esophagitis (RE) had longer acid reflux times preoperatively compared to those without RE, indicating a more severe reflux condition.

Post-surgery, both groups showed significant improvements in lower esophageal sphincter (LES) function and reflux parameters, but there were no changes in esophageal body motor function, suggesting that while surgical intervention benefits reflux control, it does not affect the overall motility of the esophagus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of reflux esophagitis on the esophageal function before and after laparoscopic fundoplication. Hoshino, M., Omura, N., Yano, F., et al.[2019]

In a study of 36 patients, baseline impedance (BI) values obtained from high-resolution impedance manometry (HRIM) showed a correlation with mean nocturnal baseline impedance (MNBI) at specific recording sites, indicating that both methods can provide similar insights into esophageal function during physiologic acid exposure time.

However, there were notable differences in BI values between two HRIM manufacturers, with Diversatek showing lower BI than Medtronic, suggesting that the choice of manufacturer may affect impedance measurements and that further research is needed to standardize these measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esophageal Baseline Impedance From High-resolution Impedance Manometry Correlates With Mean Nocturnal Baseline Impedance From pH-impedance Monitoring. Horton, A., Sullivan, B., Charles, K., et al.[2020]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

A systematic review of current methodology of high resolution pharyngeal manometry with and without impedance. [2020]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Validation of Pharyngeal Acid Reflux Episodes Using Hypopharyngeal Multichannel Intraluminal Impedance-pH. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Diagnosis of Swallowing Disorders: How We Interpret Pharyngeal Manometry. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Combined impedance-manometry for the evaluation of esophageal disorders. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Study on laryngopharyngeal and esophageal reflux characteristics using 24-h multichannel intraluminal impedance-pH monitoring in healthy volunteers. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical applications of esophageal impedance monitoring and high-resolution manometry. [2022]

7. Japan pubmed.ncbi.nlm.nih.gov

Impact of reflux esophagitis on the esophageal function before and after laparoscopic fundoplication. [2019]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Esophageal Baseline Impedance From High-resolution Impedance Manometry Correlates With Mean Nocturnal Baseline Impedance From pH-impedance Monitoring. [2020]