Extraesophageal Reflux - Feasibility of Measurement of Pepsin in Saliva as a Diagnostic Option

Study Overview
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Brief Summary
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The diagnostics of extraesophageal reflux (EER) is challenging. Currently, 24-h dual-probe esophageal pH monitoring or impedance is considered the best diagnostic method for EER. The 24-h oropharyngeal pH monitoring is a newer method aimed at detecting episodes of reflux to the oropharynx. Unfortunately, all these methods have many disadvantages. Pepsin detection in saliva would be an almost ideal diagnostic technique. However, data of its reliability is lacking. The aim of the study is to compare results of oropharyngeal pH monitoring and esophageal impedance monitoring, compared to a quantified pepsin presence in the saliva obtained immediately prior to 24-hour monitoring and to evaluate the feasibility of this technique as a routine option of diagnosing the presence of extraesophageal reflux.

Detailed Description
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Extraesophageal reflux (EER) has recently been found to be a risk factor for many head and neck pathologies. Many studies have shown that contact between the refluxed content and mucous tissue can cause local inflammation and edema and thus facilitate the development of inflammation. Although important, the diagnostics of EER is not easy. The simplest means of collecting information about reflux problems is questioning potential sufferers. However, although many questionnaires have been developed over the last few years, questioning is still not a suitable technique for the evaluation of EER, the reason being that symptoms of EER are heterogeneous and very common. Currently, 24-h dual-probe esophageal pH monitoring or impedance is considered the best diagnostic method for EER. The 24-h oropharyngeal pH monitoring is a newer method aimed at detecting episodes of reflux to the oropharynx and seems to generate similar results. However, these methods may not be tolerated well. Moreover, the position of the sensor, which is placed in the hypopharynx or oropharynx, does not precisely reflect the amount of reflux content that reaches larynx, nasopharynx, nasal cavity or middle ear. Another disadvantage of pH monitoring is that it enables only a short-term analysis over a timespan of just 24-48 h. Detection of pepsin in fluids and tissues is considered by some authors to be perhaps more appropriate than pH monitoring because it reflects the long-term effects of EER and proves that EER is truly affecting the examined region. This is particularly true for more distant regions like the middle ear. Pepsin detection in saliva would be very well tolerated and fast diagnostic method. However, data of its reliability are lacking. The aim of the study is to compare results of oropharyngeal pH monitoring and esophageal impedance monitoring, compared to a quantified pepsin presence in the saliva obtained immediately prior to 24-hour monitoring and to evaluate the feasibility of this diagnostic option as a routine method.

Official Title
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Extraesophageal Reflux - Feasibility of Measurement of Pepsin in Saliva as a Diagnostic Option

Conditions
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Extraesophageal Reflux

Intervention / Treatment
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* Diagnostic Test: Pepsin in saliva test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - suspicion of EER indicated for diagnostics Exclusion Criteria: head and neck cancer not-signing of the informed consent with participation in the study intolerance of 24-hour monitoring treatment with proton pump inhibitors

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients will be randomized into two study arms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitoring of pH with Restech<br>The patients with EER randomized into this arm will undergo pH monitoring using Restech system | Diagnostic Test: Pepsin in saliva test<br>* The presence of pepsin in the saliva will be tested in both groups of patients.<br>|
| Experimental: Monitoring of oesophageal impedance<br>The patients with EER randomized into this arm will undergo monitoring of oesophageal impedance | Diagnostic Test: Pepsin in saliva test<br>* The presence of pepsin in the saliva will be tested in both groups of patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflux symptom index (RSI) | Reflux symptom index is a standard tool in the form of a questionnaire scale where the patients evaluate their problems related to reflux on a scale of 0 (no problems) to 5 (severe). The value of RSI over 13 may be indicative of serious reflux-related problems. | 24 hours | 
| Reflux finding score (RFS) | Reflux finding score is a standard tool for assessing the presence and severity of reflex, evaluating reflux symptoms in eight areas. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of pepsin in the saliva | The presence of pepsin in the saliva will be assessed. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extraesophageal reflux, laryngopharyngeal reflux, pepsin, saliva, oropharyngeal pH monitoring, esophageal impedance