Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06773702

Evaluation of Upper Esophageal Sphincter Motor Activity in Patients with Extra Esophageal Reflux Symptoms

To evaluate the presence of motor changes of the upper esophageal sphincter detectable by high-resolution manometry in patients with oropharyngeal symptoms referable to extra-esophageal reflux manifestations.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

About this study

Gastroesophageal reflux disease (GERD) is a condition that occurs when the passage of gastric contents into the esophagus becomes clinically symptomatic and results in the appearance of complications. The incidence is higher in countries with high socioeconomic status; in fact, the prevalence in the US is estimated to be between 15 and 30 percent of the population compared with 5 to 10 percent in eastern countries such as China. 1 Typical manifestations are heartburn and acid regurgitation; however, in some cases it may manifest with extraesophageal symptoms, termed atypical, resulting from the involvement of anatomical areas of otolaryngological and pulmonary relevance.

According to the 2006 Montreal classification (Figure 1), still the reference of gastroesophageal reflux disease, the disease can manifest with:

  • esophageal syndrome, subdivided into:
  • symptomatic, without esophageal injury (typical reflux syndrome, Chest pain syndrome)
  • syndrome with esophageal damage (esophagitis, stenosis, Barrett's esophagus and Adenocarcinoma of the esophagus)
  • extraesophageal syndrome, subdivided into:
  • association with established reflux disease (chronic cough, laryngitis, asthma, dental erosions)
  • association with proposed reflux disease (pharyngitis, sinusitis, idiopathic pulmonary fibrosis, recurrent otitis media).

A study performed by Francis DO in the United States in 2013 showed how the management of extra esophageal reflux disease substantially burdens public spending. In fact, it was found that the cost for the first year of evaluation and treatment of patients presenting with extra esophageal reflux symptoms is five times higher than the management of typical esophageal reflux disease. The cause of this discrepancy is precisely the absence of a definitive diagnosis and standard treatment, which result in difficult management of the disease.

While there is ample literature regarding the association between MRGE and alteration of the lower esophageal sphincter, little is described about the correlation between alterations in pharyngo-laryngeal motor activity and the upper esophageal sphincter in patients with extraesophageal reflux disease symptoms.

Indeed, it is hypothesized that the reflux of acidic material at the level of the larynx may be due to a dysfunction of the sphincter that acts as an escape valve between the esophagus and pharyngo-larynx. With the development of high-resolution manometry, which, unlike conventional manometry, has no spatial gaps and allows for a faithful representation of esophageal motor function in time and space, a detailed study of oropharyngeal and upper esophageal sphincter motor activity can be achieved

The observational, non-interventional nature of the study is based on two main elements:

  • the evaluation of data obtained from high-resolution esophageal manometry in patients with extra-esophageal reflux symptoms
  • the comparison of data obtained from high-resolution esophageal manometry with 24-hour PH-impedancemetry and otolaryngological scores of laryngopharyngeal reflux (Reflux symptom Index, Reflux Finding Score) Patients participating in the study will not undergo any procedures beyond normal daily clinical practice; likewise, the clinical variables that will be collected for the study are those that are commonly collected by the physician in daily clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

.

  • Age between 18 and 80 years.
  • Patients with laryngopharyngeal reflux symptoms.
  • Obtaining informed consent. Exclusion criteria.
  • Patients with tobacco habit.
  • Patients with occupational exposure to irritants (artisans and industrial workers).

Treatment and study plan

gastroenterology and otolaryngological evaluation

Other
  • Gastroenterology evaluation: presence and intensity of esophageal symptoms of gastro esophageal reflux disease, high-resolution esophageal manometry, and 24-hour pH-impedancometry in the absence of PPI therapy.
  • otolaryngological evaluation: presence and intensity of laryngopharyngeal reflux symptoms, laryngoscopy.

Primary outcomes

  1. Evaluate the presence of motor changes of the upper esophageal sphincter detectable on high-resolution manometry in patients with oropharyngeal symptoms referable to extra-esophageal reflux manifestations.

    Time frame: 1 year

    Evaluate the presence of motor changes of the upper esophageal sphincter detectable on high-resolution manometry in patients with oropharyngeal symptoms referable to extra-esophageal reflux manifestations.

Secondary outcomes

  1. PH-impedancemetry

    Time frame: 1 year

    The secondary objectives of the study are contingent on the actual presence of manometric alterations of the upper esophageal sphincter in patients with extraesophageal syndrome. Basically, if no manometric changes are present, secondary objectives will: assess the association between manometric changes and the result of PH-impedancemetry

  2. Reflux Index Score

    Time frame: 1 year

    The secondary objectives of the study are contingent on the actual presence of manometric alterations of the upper esophageal sphincter in patients with extraesophageal syndrome. Basically, if no manometric changes are present, secondary objectives will: evaluate the association between manometric alterations and the result of Reflux Index Score

  3. Reflux Symptom Index

    Time frame: 1 year

    The secondary objectives of the study are contingent on the actual presence of manometric alterations of the upper esophageal sphincter in patients with extraesophageal syndrome. Basically, if no manometric changes are present, secondary objectives will: evaluate the association between manometric alterations and the result of the Reflux Symptom Index

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Valutazione Dell'attività Motoria Dello Sfintere Esofageo Superiore Nei Pazienti Con Sintomi Extra Esofagei Da Reflusso

Important dates

Study start
2020
Primary completion
2021
Study completion
2025
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.