Gastroesophageal Reflux Disease
Conditions
Keywords
GERD, tLESR, impedance, manometry
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 disease (GERD) patients.
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 patients with reflux symptoms resistant to proton pump inhibitors. HRM is the gold standard for detecting and characterizing tLESR, and could be considered as part of the pharmacological evaluation of new drugs targeting tLESRs. HRM criteria for the objective definition of tLESRs in GERD patients have to be established, as it has been done in healthy patients Subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.
Interventions
PROCEDUREHigh resolution manometry
Subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.
Sponsors
University Hospital, Bordeaux
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tLESRs characteristics | Inclusion (Day 0) | To characterize tLESRs defined according following criteria: * LES basal pressure (mmHg) defined as LES pressure during relaxation * LES minimum pressure during relaxation * Duration of the LES relaxation (seconds) * Integrated relaxation pressure (4 seconds) |
| Reflux underlying mechanisms | Inclusion (Day 0) | To detect every reflux and to determine underlying mechanisms * Transient lower esophageal sphincter relaxations (tLESR) * Low basal LES pressure (free reflux) * Increased abdominal pressure * Swallow * Another mechanism |
Countries
France
Outcome results
None listed