IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138, Italy
NCT Number: NCT06773702
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–80 year
All sexes
Observational
Bologna, 40138, Italy
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:
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
.
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.
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
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
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
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Other
Valutazione Dell'attività Motoria Dello Sfintere Esofageo Superiore Nei Pazienti Con Sintomi Extra Esofagei Da Reflusso
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