Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD.

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Procedure: High resolution manometry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HRM<br> | Procedure: High resolution manometry<br>* Subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tLESRs characteristics | 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) | Inclusion (Day 0) | 
| Reflux underlying mechanisms | 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 | Inclusion (Day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, tLESR, impedance, manometry