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

University Hospital, Bordeaux15 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Gastroesophageal Reflux Disease

Interventions

High resolution manometryPROCEDURE

Subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

Service d'hépato-gastroentérologie et oncologie digestive

Bordeaux, Bordeaux, France

Service d'Exploration Fonctionnelle Digestive

Lyon, Lyon, France

Institut des Maladies de l'Appareil Digestif (IMAD)

Nantes, Nantes, France

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: Inclusion (Day 0)

Data from ClinicalTrials.gov

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