Clinical Trial: Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal Reflux

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal Reflux

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 Summary: 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.
Sponsor: University Hospital, Bordeaux

Current Primary Outcome:

  • Number of pharyngeal reflux/24h [ Time Frame: visit 3 - 60 days after inclusion ]
  • • Number of pharyngeal acid reflux/24h [ Time Frame: Visit 3 - 60 days after inclusion ]
  • • Number of pharyngeal less acid reflux/24h [ Time Frame: Visit 3 - 60 days after inclusion ]
  • • Pharyngeal acid exposure (% of total time with pharyngeal pH <4) [ Time Frame: Visit 3 - 60 days after inclusion ]
  • • Pharyngeal bolus exposure (% of total time with liquid in the pharynx) [ Time Frame: Visit 3 - 60 days after inclusion ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospital, Bordeaux

Dates:
Date Received: May 3, 2013
Date Started: May 2013
Date Completion:
Last Updated: July 22, 2015
Last Verified: July 2015