Extraesophageal Reflux - Feasibility of Measurement of Pepsin in Saliva as a Diagnostic Option
Condition: Extraesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Pepsin in saliva test
Intervention type(s): Diagnostic Test
Intervention description(s): The presence of pepsin in the saliva will be tested in both groups of patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients will be randomized into two study arms.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: extraesophageal reflux; laryngopharyngeal reflux; pepsin; saliva; oropharyngeal pH monitoring; esophageal impedance