Status:
COMPLETED
Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The aim of this study is to establish and validate High resolution manometry (HRM) criteria for the definition of transient lower esophageal sphincter relaxations (tLESRs) in gastroesophageal reflux d...
Detailed Description
tLESRs represent the main mechanism of all types of reflux events. Inhibition of transient lower esophageal sphincter relaxations (tLESRs) has become one of the most relevant therapeutic objectives in...
Eligibility Criteria
Inclusion
- Patients 18 to 75 years old
- GERD documented by :
- Typical reflux symptoms (heartburn, regurgitations) completely responsive to PPI therapy
- And/or erosive esophagitis or Barrett's esophagus at endoscopy
- And/or positive pH 24h monitoring (acid exposure time \> 5% or positive symptom association indices)
- Possibility of easily positioned transnasal catheter
- Patients covered by social security
- Subjects must provide written, free and informed consent
Exclusion
- Pregnant or lactating women
- History of digestive or thoracic surgery (except appendicectomy)
- Patients unable to stop PPI therapy for 7 days
- Subjects unable to provide written consent, including adult under guardianship and emergency situation
- Simultaneous participation in another study
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01844440
Start Date
April 1 2013
End Date
January 1 2014
Last Update
July 2 2014
Active Locations (3)
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1
Service d'hépato-gastroentérologie et oncologie digestive
Bordeaux, Bordeaux, France, 33075
2
Service d'Exploration Fonctionnelle Digestive
Lyon, Lyon, France, 69437
3
Institut des Maladies de l'Appareil Digestif (IMAD)
Nantes, Nantes, France, 44000