Clinical trial NCT01854970: Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal Reflux
Official title: Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal Reflux
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngopharyngeal Reflux
Oesophageal pH-impedance
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Laryngopharyngeal reflux (LPR) is the retrograde movement of gastric contents into the larynx, pharynx and upper aerodigestive tract. The symptoms and manifestations are very changeable and non specific. Pharyngeal and Oesophageal pH-impedance may help to detect these reflux and to identify patients with abnormal LPR.

To compare and describe the results of pharyngeal and oesophageal pH-impedance of patients with high suspicion of laryngopharyngeal reflux, with the results of healthy patients.

Detailed description: This is a monocentric, prospective descriptive study. Patients will be recruited in otolaryngology and gastroenterology departments of Bordeaux teaching hospital. A first clinical, endoscopic and pH-impedance evaluation will be made, after at least 15 days of interruption of any proton pump inhibitors (PPI). After 8 weeks' treatment by double PPI doses (esomeprazole 40 mg bid), another clinical and pH-impedance evaluation will be realized. The characteristics of the patients who respond to the treatment will be compared to non responders. The subjects will also have an initial laryngoscopy, an oesophageal manometry allowing the location of the lower sphincter of the oesophagus and the upper sphincter of the oesophagus for positioning the catheters.

Eligibility criteria: Inclusion Criteria:

* age : 18 to 80 years old.
* Written consent
* Laryngopharyngeal symptoms (dysphonia, and/or globus and/or sensation, and/or pharyngeal pain, and/or cough) for 3 months at least.
* No PPI for at least 15 days
* Social security affiliation

Exclusion Criteria:

* Sinusitis or chronic rhinitis (in the previous year)
* Laryngeal trauma, tracheotomy or pharyngolaryngeal surgery
* pregnancy or absence of efficacy contraception
* breast feeding
* history of gastrointestinal pathology, diabetes, neurological condition
* cardio-vascular history requiring the taking of Plavix
* esomeprazole contraindication or intolerance

Primary outcomes:
measure: Number of pharyngeal reflux/24h
timeFrame: visit 3 - 60 days after inclusion
measure: • Number of pharyngeal acid reflux/24h
timeFrame: Visit 3 - 60 days after inclusion
measure: • Number of pharyngeal less acid reflux/24h
timeFrame: Visit 3 - 60 days after inclusion
measure: • Pharyngeal acid exposure (% of total time with pharyngeal pH <4)
timeFrame: Visit 3 - 60 days after inclusion
measure: • Pharyngeal bolus exposure (% of total time with liquid in the pharynx)
timeFrame: Visit 3 - 60 days after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
References: